AbbVie Submits Application to FDA for Upadacitinib (RINVOQ®) for Adults and Adolescents with Severe Alopecia Areata
Rhea-AI Summary
AbbVie (NYSE: ABBV) submitted an FDA application for upadacitinib (RINVOQ) 15 mg and 30 mg once daily for adults and adolescents with severe alopecia areata, based on Phase 3 UP-AA data.
In two replicate trials (N=1,399), the primary endpoint SALT ≤ 20 at week 24 was met for both doses; response rates improved through week 52. Safety through week 52 was described as consistent with earlier results. Use in AA is not approved and remains under regulatory review.
Positive
- Primary endpoint met: SALT ≤ 20 at week 24 for both doses
- Upadacitinib 30 mg achieved 55.0% and 54.3% SALT ≤ 20 in studies
- Complete scalp coverage (SALT = 0) observed at week 24 up to 22.5%–20.3%
- Responses improved further through week 52 in the blinded extension
Negative
- Use in alopecia areata is not approved; approval is pending FDA review
- Placebo-controlled period ended at week 24; week 52 data are descriptive
News Market Reaction – ABBV
In the Apr 28 session, ABBV gained 0.16%, reflecting a mild positive market reaction. Argus tracked a peak move of +8.7% during that session. Our momentum scanner triggered 4 alerts that day, indicating moderate trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Apr 23 | Regulatory setback | Negative | -1.1% | FDA Complete Response Letter for TrenibotE manufacturing information. |
| Apr 22 | Capex expansion | Positive | -1.5% | Announcement of $1.4B Durham manufacturing campus and job creation. |
| Apr 14 | Marketing initiative | Neutral | +1.8% | Natrelle® breast augmentation awareness and patient education campaign. |
| Apr 13 | Licensing deal | Positive | -0.7% | Exclusive global rights (ex-China regions) to Haisco pain compounds. |
| Apr 08 | Brand program | Positive | +2.5% | BOTOX® Cosmetic Confidence Collective grants and support for entrepreneurs. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Recent ABBV news shows mixed alignment: some positive strategic or pipeline updates coincided with share declines, while brand and program announcements saw modest gains.
Over the past month, AbbVie issued several notable updates, including a Complete Response Letter on TrenibotE (Apr 23), a new $1.4 billion North Carolina manufacturing campus plan (Apr 22), licensing of multiple pain compounds from Haisco (Apr 13), and brand initiatives for Natrelle® and BOTOX® Cosmetic. Market reactions alternated between declines on regulatory/manufacturing news and gains on aesthetic brand programs. Today’s upadacitinib alopecia areata filing extends the company’s recent run of pipeline and portfolio developments.
Key Terms
alopecia areata medical
severity of alopecia tool (SALT) medical
SALT score medical
Phase 3 medical
double-blind medical
placebo-controlled medical
JAK inhibitor medical
non-responder imputation technical
AI-generated analysis. How Rhea-AI works. Not financial advice.
- Submission is supported by data from the Phase 3 UP-AA clinical program in which upadacitinib achieved the primary endpoint of severity of alopecia tool (SALT) score ≤ 20 at week 24, with additional efficacy results observed at week 521-3
- Upadacitinib is also the first JAK inhibitor to meet the ranked secondary endpoint of complete scalp hair regrowth (SALT = 0) at week 241-3
"Alopecia areata is a chronic immune-mediated disease in which the physical and psychological burden patients can experience goes far beyond hair loss, impacting their day-to-day lives," said Kori Wallace, M.D., Ph.D., vice president, global head of immunology clinical development, AbbVie. "In the UP-AA clinical program, upadacitinib showed early and substantial scalp hair growth, including complete scalp hair coverage, which is a significant outcome for those living with this often-overlooked disease."
UP-AA Clinical Trial Summary1-3
UP-AA includes two replicate studies with Period A as a double-blind, placebo-controlled phase for 24 weeks, followed by Period B, a blinded extension through 52 weeks. Results from Period B are summarized descriptively.
The mean baseline SALT score across the trials was 84 and approximately
Phase 3 UP-AA Efficacy Results (NRI)1-3* | |||||||
Study 1 | Study 2 | ||||||
Pbo N=135 % | Upa 15 mg N=270 % | Upa 30 mg N=271 % | Pbo N=145 % | Upa 15 mg N=289 % | Upa 30 mg N=289 % | ||
Substantial | Week | 1.5 % | 45.2 % | 55.0 % | 3.4 | 44.6 % | 54.3 % |
Week | N/A† | 59.3 % | 63.8 % | N/A† | 55.0 % | 63.3 % | |
Complete | Week | 0 | 14.1 % | 20.3 % | 0.7 % | 13.1 % | 22.5 % |
Week | N/A† | 28.5 % | 35.8 % | N/A† | 26.6 % | 37.0 % | |
*The primary endpoint was SALT score ≤ 20 at week 24, and a key ranked secondary endpoint was SALT score = 0 at week 24 from the double-blind, placebo-controlled Period A. Data at week 52 are descriptive from the blinded extension Period B. SALT score ≤ 20 indicates ≥ | |||||||
The safety profile of upadacitinib 15 mg and 30 mg through week 52 was consistent with that observed at week 24 and shared in previously announced results.1-3
Use of upadacitinib in AA is not approved; its safety and efficacy are under regulatory review by the
About UP-AA Clinical Trial1-3
UP-AA M23-716 was conducted as a single protocol that includes two replicate pivotal studies (Study 1 and Study 2) with randomization, investigative sites, data collection, analysis and reporting independent for each study. These Phase 3 randomized, placebo-controlled, double-blind studies evaluate the efficacy and safety of upadacitinib in adult and adolescent patients with severe alopecia areata. In Study 1 and Study 2 Period A, participants were randomized to one of three groups to receive upadacitinib 15 mg, upadacitinib 30 mg or placebo for 24 weeks. In Study 1 and Study 2 Period B, participants originally randomized to upadacitinib dose groups in Period A continued their same treatment in Period B for 28 additional weeks. Participants originally randomized to placebo in Period A either remained on placebo in Period B or were re-randomized to either upadacitinib 15 or upadacitinib 30 mg, based on their SALT score at week 24. In total, Study 1 and Study 2 Periods A and B span 52 weeks. Results from Period B are summarized descriptively. Participants who complete Study 1 or Study 2 can join Study 3 and may be re-randomized to receive 1 of 2 doses of upadacitinib for up to 108 weeks, where data is summarized descriptively. The two trials randomized 1,399 participants with severe AA ages 12 to 63 across 248 sites worldwide. More information on this trial can be found at www.clinicaltrials.gov (NCT06012240).
About Alopecia Areata
Alopecia areata (AA) is an unpredictable autoimmune disease causing a range of hair loss patterns, from sudden, round bald patches on the scalp to complete loss of all body hair, including scalp, face, eyebrows and eyelashes.4,5 Despite its immune-mediated nature, AA is often considered a cosmetic problem, which can lead to stigma and have an impact on patients' lives.6,7
About RINVOQ® (upadacitinib)
Discovered and developed by AbbVie scientists, RINVOQ is a JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. Based on enzymatic and cellular assays, RINVOQ demonstrated greater inhibitory potency for JAK-1 vs JAK-2, JAK-3, and TYK-2. The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness and safety is not currently known.
Upadacitinib (RINVOQ) is being studied in Phase 3 clinical trials for alopecia areata, hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus, and vitiligo. The use of upadacitinib in alopecia areata is not approved; its safety and efficacy are under regulatory review by the
RINVOQ (upadacitinib)
RINVOQ is a prescription medicine used to treat:
- Adults with moderate to severe rheumatoid arthritis (RA) when 1 or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well or could not be tolerated.
- Adults with active psoriatic arthritis (PsA) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated.
- Adults with active ankylosing spondylitis (AS) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated.
- Adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation when a TNF blocker medicine has been used, and did not work well or could not be tolerated.
- Adults with giant cell arteritis (GCA).
- Adults with moderate to severe ulcerative colitis (UC) when 1 or more medicines called TNF blockers have been used and did not work well or could not be tolerated, or after taking a different injection or pill (systemic therapy) when your healthcare provider does not recommend TNF blockers.
- Adults with moderate to severe Crohn's disease (CD) when 1 or more medicines called TNF blockers have been used and did not work well or could not be tolerated, or after taking a different injection or pill (systemic therapy) when your healthcare provider does not recommend TNF blockers.
It is not known if RINVOQ is safe and effective in children with ankylosing spondylitis, non-radiographic axial spondyloarthritis, ulcerative colitis, or Crohn's disease.
- Adults and children 12 years of age and older with moderate to severe eczema (atopic dermatitis [AD]) that did not respond to previous treatment and their eczema is not well controlled with other pills or injections, including biologic medicines, or the use of other pills or injections is not recommended.
It is not known if RINVOQ is safe and effective in children under 12 years of age with atopic dermatitis.
It is not known if RINVOQ LQ is safe and effective in children with atopic dermatitis.
RINVOQ/RINVOQ LQ is a prescription medicine used to treat:
- Children 2 years of age and older with active polyarticular juvenile idiopathic arthritis (pJIA) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated.
- Children 2 to less than 18 years of age with active psoriatic arthritis (PsA) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated.
It is not known if RINVOQ/RINVOQ LQ is safe and effective in children under 2 years of age with polyarticular juvenile idiopathic arthritis or psoriatic arthritis.
IMPORTANT SAFETY INFORMATION FOR RINVOQ/RINVOQ LQ (upadacitinib)
What is the most important information I should know about RINVOQ*?
RINVOQ may cause serious side effects, including:
- Serious infections. RINVOQ can lower your ability to fight infections. Serious infections have happened while taking RINVOQ, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your healthcare provider (HCP) should test you for TB before starting RINVOQ and check you closely for signs and symptoms of TB during treatment with RINVOQ. You should not start taking RINVOQ if you have any kind of infection unless your HCP tells you it is okay. If you get a serious infection, your HCP may stop your treatment until your infection is controlled. You may be at higher risk of developing shingles (herpes zoster).
- Increased risk of death in people 50 years and older who have at least 1 heart disease (cardiovascular) risk factor.
- Cancer and immune system problems. RINVOQ may increase your risk of certain cancers. Lymphoma and other cancers, including skin cancers, can happen. Current or past smokers are at higher risk of certain cancers, including lymphoma and lung cancer. Follow your HCP's advice about having your skin checked for skin cancer during treatment with RINVOQ. Limit the amount of time you spend in sunlight. Wear protective clothing when you are in the sun and use sunscreen.
- Increased risk of major cardiovascular (CV) events, such as heart attack, stroke, or death, in people 50 years and older who have at least 1 heart disease (CV) risk factor, especially if you are a current or past smoker.
- Blood clots. Blood clots in the veins of the legs or lungs and arteries can happen with RINVOQ. This may be life-threatening and cause death. Blood clots in the veins of the legs and lungs have happened more often in people who are 50 years and older and with at least 1 heart disease (CV) risk factor.
- Allergic reactions. Symptoms such as rash (hives), trouble breathing, feeling faint or dizzy, or swelling of your lips, tongue, or throat, that may mean you are having an allergic reaction have been seen in people taking RINVOQ. Some of these reactions were serious. If any of these symptoms occur during treatment with RINVOQ, stop taking RINVOQ and get emergency medical help right away.
- Tears in the stomach or intestines. This happens most often in people who take nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids. Get medical help right away if you get stomach-area pain, fever, chills, nausea, or vomiting.
- Changes in certain laboratory tests. Your HCP should do blood tests before you start taking RINVOQ and while you take it. Your HCP may stop your RINVOQ treatment for a period of time if needed because of changes in these blood test results.
Do not take RINVOQ if you are allergic to upadacitinib or any of the ingredients in RINVOQ. See the Medication Guide or Consumer Brief Summary for a complete list of ingredients.
What should I tell my HCP BEFORE starting RINVOQ?
Tell your HCP if you:
- Are being treated for an infection, have an infection that won't go away or keeps coming back, or have symptoms of an infection, such as:
| ̶ Fever, sweating, or chills ̶ Shortness of breath ̶ Warm, red, or painful skin or | ̶ Muscle aches ̶ Feeling tired ̶ Blood in phlegm ̶ Diarrhea or stomach pain | ̶ Cough ̶ Weight loss ̶ Burning when urinating or urinating more often than normal |
- Have TB or have been in close contact with someone with TB.
- Are a current or past smoker.
- Have had a heart attack, other heart problems, or stroke.
- Have or have had any type of cancer, hepatitis B or C, shingles (herpes zoster), blood clots in the veins of your legs or lungs, diverticulitis (inflammation in parts of the large intestine), or ulcers in your stomach or intestines.
- Have other medical conditions, including liver problems, low blood cell counts, diabetes, chronic lung disease, HIV, or a weak immune system.
- Live, have lived, or have traveled to parts of the country, such as the Ohio and Mississippi River valleys and the Southwest, that increase your risk of getting certain kinds of fungal infections. If you are unsure if you've been to these types of areas, ask your HCP.
- Have recently received or are scheduled to receive a vaccine. People who take RINVOQ should not receive live vaccines.
- Are pregnant or plan to become pregnant. Based on animal studies, RINVOQ may harm your unborn baby. Your HCP will check whether or not you are pregnant before you start RINVOQ. You should use effective birth control (contraception) to avoid becoming pregnant during treatment with RINVOQ and for 4 weeks after your last dose.
- There is a pregnancy surveillance program for RINVOQ. The purpose of the program is to collect information about the health of you and your baby. If you become pregnant while taking RINVOQ, you are encouraged to report the pregnancy by calling 1-800-633-9110.
- Are breastfeeding or plan to breastfeed. RINVOQ may pass into your breast milk. Do not breastfeed during treatment with RINVOQ and for 6 days after your last dose.
Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. RINVOQ and other medicines may affect each other, causing side effects.
Especially tell your HCP if you take:
- Medicines for fungal or bacterial infections
- Rifampicin or phenytoin
- Medicines that affect your immune system
If you are not sure if you are taking any of these medicines, ask your HCP or pharmacist.
What should I avoid while taking RINVOQ?
Avoid food or drink containing grapefruit during treatment with RINVOQ as it may increase the risk of side effects.
What should I do or tell my HCP AFTER starting RINVOQ?
- Tell your HCP right away if you have any symptoms of an infection. RINVOQ can make you more likely to get infections or make any infections you have worse.
- Get emergency help right away if you have any symptoms of a heart attack or stroke while taking RINVOQ, including:
- Discomfort in the center of your chest that lasts for more than a few minutes or that goes away and comes back
- Severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
- Pain or discomfort in your arms, back, neck, jaw, or stomach
- Shortness of breath with or without chest discomfort
- Breaking out in a cold sweat
- Nausea or vomiting
- Feeling lightheaded
- Weakness in one part or on one side of your body
- Slurred speech
- Tell your HCP right away if you have any signs or symptoms of blood clots during treatment with RINVOQ, including:
| ̶ Swelling ̶ Pain or tenderness in one or both legs | ̶ Sudden unexplained chest or upper back pain ̶ Shortness of breath or difficulty breathing |
- Tell your HCP right away if you have a fever or stomach-area pain that does not go away, and a change in your bowel habits.
What are other possible side effects of RINVOQ?
Common side effects include upper respiratory tract infections (common cold, sinus infections), shingles (herpes zoster), herpes simplex virus infections (including cold sores), bronchitis, nausea, cough, fever, acne, headache, swelling of the feet and hands (peripheral edema), increased blood levels of creatine phosphokinase, allergic reactions, inflammation of hair follicles, stomach-area (abdominal) pain, increased weight, flu, tiredness, lower number of certain types of white blood cells (neutropenia, lymphopenia, leukopenia), muscle pain, flu-like illness, rash, increased blood cholesterol levels, increased liver enzyme levels, pneumonia, low number of red blood cells (anemia), and infection of the stomach and intestine (gastroenteritis).
A separation or tear to the lining of the back part of the eye (retinal detachment) has happened in people with atopic dermatitis treated with RINVOQ. Call your HCP right away if you have any sudden changes in your vision during treatment with RINVOQ.
Some people taking RINVOQ may see medicine residue (a whole tablet or tablet pieces) in their stool. If this happens, call your HCP.
These are not all the possible side effects of RINVOQ.
How should I take RINVOQ/RINVOQ LQ?
RINVOQ is taken once a day with or without food. Do not split, crush, or chew the tablet. Take RINVOQ exactly as your HCP tells you to use it. RINVOQ is available in 15 mg, 30 mg, and 45 mg extended-release tablets. RINVOQ LQ is taken twice a day with or without food. RINVOQ LQ is available in a 1 mg/mL oral solution. RINVOQ LQ is not the same as RINVOQ tablets. Do not switch between RINVOQ LQ and RINVOQ tablets unless the change has been made by your HCP.
*Unless otherwise stated, "RINVOQ" in the IMPORTANT SAFETY INFORMATION refers to RINVOQ and RINVOQ LQ.
This is the most important information to know about RINVOQ. For more information, talk to your HCP.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/PatientAccessSupport to learn more.
Please click here for the Full Prescribing Information and Medication Guide.
Globally, prescribing information varies; refer to the individual country product label for complete information.
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2025 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
References
- AbbVie. Data on file ABVRRTI81580.
- AbbVie. Data on file ABVRRTI81456.
- AbbVie. Data on file ABVRRTI83115.
- Alkhalifah A, Alsantali A, Wang E, McElwee KJ, Shapiro J. Alopecia areata update: Part I. Clinical picture, histopathology, and pathogenesis. J Am Acad Dermatol. 2010;62(2):177-188, quiz 189-190.
- Pratt CH, King LE, Messenger AG, Christiano AM, Sundberg JP. Alopecia areata. Nat Rev Dis Primers. 2017;3(1):17011
- Davey L, Clarke V, Jenkinson E. Living with alopecia areata: an online qualitative survey study. Br J Dermatol. 2019;180(6):1377-1389
- Bain KA, McDonald E, Moffat F, et al. Alopecia areata is characterized by dysregulation in systemic type 17 and type 2 cytokines, which may contribute to disease-associated psychological morbidity. Br J Dermatol. 2020;182(1):130-137
- RINVOQ [Package Insert]. North Chicago, IL: AbbVie Inc.; 2025
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