Update on FDA Priority Review of Dupixent® (dupilumab) for the Treatment of COPD Patients with Type 2 Inflammation
Regeneron Pharmaceuticals and Sanofi announced that the U.S. FDA has extended the target action date for the priority review of Dupixent (dupilumab) by three months to September 27, 2024. This extension follows the submission of additional efficacy analyses requested by the FDA for the BOREAS and NOTUS pivotal trials. The FDA has no concerns about the approvability of Dupixent for treating uncontrolled COPD with type 2 inflammation. The companies are optimistic that this supplemental Biologics License Application (sBLA) will be approved. Additionally, reviews are ongoing with regulatory authorities in the EU and China. The EMA has already recommended approval in the EU. However, the safety and efficacy of Dupixent in COPD have not been fully evaluated by any regulatory authority.
- FDA has no concerns regarding the approvability of Dupixent for COPD.
- Additional analyses submitted support the efficacy of Dupixent.
- EMA has adopted a positive opinion recommending Dupixent's approval in the EU.
- Regulatory reviews for Dupixent in COPD are ongoing globally, including in China.
- FDA has extended the target action date by three months, potentially delaying market entry.
- Safety and efficacy of Dupixent in COPD have not been fully evaluated by any regulatory authority.
Insights
The extension of the FDA's target action date for Dupixent's new indication in COPD signifies a critical step in the drug approval process. The request for additional efficacy analyses from the BOREAS and NOTUS trials suggests that while the FDA sees potential in Dupixent, it requires more data to substantiate its effectiveness for COPD patients with type 2 inflammation. This extended timeline could introduce short-term uncertainty for investors, but it is not unusual in the regulatory process and indicates thorough due diligence by the FDA. Dupixent's existing success in treating other conditions like eczema and asthma enhances its credibility as a versatile biologic, potentially expanding its market significantly if approved for COPD. Investors should note that ongoing reviews by other regulatory bodies, including the EMA and China, may provide additional positive momentum. However, it is important to remain cautious until full regulatory approval is achieved.
From a financial perspective, the news of the FDA's extension may introduce some volatility in Regeneron's and Sanofi's stock prices in the short term. However, the companies’ confidence in the additional analyses supporting Dupixent's approval is reassuring for long-term investors. Dupixent has already proven to be a substantial revenue driver for both companies and its potential approval for COPD could significantly boost revenues. The COPD market is substantial, given the high prevalence of the disease and capturing even a fraction of this market could be highly lucrative. Nonetheless, investors should be aware of the inherent risks and delays associated with drug approval processes, which may affect stock performance temporarily.
The extension of the FDA's review period for Dupixent in treating COPD underscores the growing trend of biologics targeting specific inflammation pathways. If approved, Dupixent could address a significant unmet need in the COPD market, particularly for patients with type 2 inflammation, which is often resistant to standard treatments. This strategic move aligns with the broader shift toward personalized medicine. Additionally, the positive opinion from the EMA's CHMP indicates strong support from another major regulatory body, which could facilitate smoother approvals elsewhere. For investors, this indicates a potential global market expansion. Yet, it is important to consider market competition, like existing COPD treatments and how Dupixent's unique mechanism of action might offer a competitive edge. Understanding the market dynamics and patient demographics will be key to evaluating the drug's future success.
TARRYTOWN, N.Y. and PARIS, May 31, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced the U.S. Food and Drug Administration (FDA) has extended by three months the target action date of its priority review of the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease (COPD). The revised target action date is September 27, 2024. The FDA did not raise any concerns regarding the approvability of Dupixent for this indication.
The FDA had requested additional analyses on the efficacy of Dupixent in the BOREAS and NOTUS pivotal trials. Based on the submission of these analyses earlier in May, the agency has now determined that this additional information constituted a major amendment to the sBLA and extended the target action date accordingly.
Regeneron and Sanofi are confident that the additional analyses strongly support the approval of Dupixent in COPD with evidence of type 2 inflammation, and are committed to working with the FDA to bring Dupixent to patients living with uncontrolled COPD as quickly as possible.
Additionally, submissions for Dupixent in COPD are currently under review with regulatory authorities around the world, including the European Union (EU) and China. Recently, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion and recommended the approval of Dupixent as an add-on maintenance treatment in adults with uncontrolled COPD characterized by raised blood eosinophils. The potential use of Dupixent in COPD is currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority.
About the BOREAS and NOTUS Trials
The sBLA is supported by data from the landmark BOREAS and NOTUS Phase 3 trials evaluating the efficacy and safety of Dupixent in adults who were current or former smokers with uncontrolled COPD with type 2 inflammation (i.e., blood eosinophils ≥300 cells per μL). All patients were on background maximal standard-of-care inhaled therapy (nearly all on triple therapy).
The primary endpoint was met in both trials, showing Dupixent significantly reduced annualized moderate or severe acute COPD exacerbations by up to
Safety results in both trials were generally consistent with the known safety profile of Dupixent in its approved indications. Adverse events more commonly observed with Dupixent (≥
About COPD
COPD is a respiratory disease that damages the lungs and causes progressive lung function decline. Symptoms include persistent cough, excessive mucus production and shortness of breath that may impair the ability to perform routine daily activities, which may lead to sleep disturbances, anxiety and depression. COPD is also associated with a significant health and economic burden due to recurrent acute exacerbations that require systemic corticosteroid treatment and/or lead to hospitalization. Smoking and exposure to noxious particles are key risk factors for COPD, but even individuals who quit smoking can still develop or continue having the disease. There have been no new treatment approaches approved for more than a decade. In the U.S., approximately 300,000 people live with uncontrolled COPD with evidence of type 2 inflammation.
About Regeneron and Sanofi’s COPD Clinical Research Program
Regeneron and Sanofi are motivated to transform the treatment paradigm of COPD by examining the role different types of inflammation play in the disease progression through the investigation of two potentially first-in-class biologics, Dupixent and itepekimab.
Dupixent inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and the program focuses on a specific population of people with evidence of type 2 inflammation. Itepekimab is a fully human monoclonal antibody that binds to and inhibits interleukin-33 (IL-33), an initiator and amplifier of broad inflammation in COPD.
Itepekimab is currently under clinical investigation, with two Phase 3 trials currently enrolling, and its safety and efficacy have not been evaluated by any regulatory authority.
About Dupixent
Dupixent, which was invented using Regeneron’s proprietary VelocImmune® technology, is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in Phase 3 trials, establishing that IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases. These diseases include approved indications for Dupixent, such as atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), eosinophilic esophagitis (EoE), prurigo nodularis and chronic spontaneous urticaria (CSU).
Dupixent has received regulatory approvals in one or more countries around the world for use in certain patients with atopic dermatitis, asthma, CRSwNP, EoE, prurigo nodularis or CSU in different age populations. Dupixent is currently approved for one or more of these indications in more than 60 countries, including in Europe, the U.S. and Japan. Approximately 850,000 patients are being treated with Dupixent globally.
About Regeneron's VelocImmune® Technology
Regeneron's VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron's co-Founder, President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite® technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create a substantial portion of all original, FDA-approved or authorized fully human monoclonal antibodies. This includes REGEN-COV® (casirivimab and imdevimab), Dupixent, Libtayo® (cemiplimab-rwlc), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab-dgnb) and Inmazeb® (atoltivimab, maftivimab and odesivimab-ebgn).
Dupilumab Development Program
Dupilumab is being jointly developed by Regeneron and Sanofi under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation.
In addition to the currently approved indications, Regeneron and Sanofi are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in Phase 3 trials, including chronic spontaneous urticaria, chronic pruritus of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation and bullous pemphigoid. These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority.
U.S. INDICATIONS
DUPIXENT is a prescription medicine used:
- to treat adults and children 6 months of age and older with moderate-to-severe eczema (atopic dermatitis or AD) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. DUPIXENT can be used with or without topical corticosteroids. It is not known if DUPIXENT is safe and effective in children with atopic dermatitis under 6 months of age.
- with other asthma medicines for the maintenance treatment of moderate-to-severe eosinophilic or oral steroid dependent asthma in adults and children 6 years of age and older whose asthma is not controlled with their current asthma medicines. DUPIXENT helps prevent severe asthma attacks (exacerbations) and can improve your breathing. DUPIXENT may also help reduce the amount of oral corticosteroids you need while preventing severe asthma attacks and improving your breathing. DUPIXENT is not used to treat sudden breathing problems. It is not known if DUPIXENT is safe and effective in children with asthma under 6 years of age.
- with other medicines for the maintenance treatment of chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults whose disease is not controlled. It is not known if DUPIXENT is safe and effective in children with chronic rhinosinusitis with nasal polyposis under 18 years of age.
- to treat adults and children 1 year of age and older with eosinophilic esophagitis (EoE), who weigh at least 33
pounds (15 kg). It is not known if DUPIXENT is safe and effective in children with eosinophilic esophagitis under 1 year of age, or who weigh less than 33pounds (15 kg). - to treat adults with prurigo nodularis (PN). It is not known if DUPIXENT is safe and effective in children with prurigo nodularis under 18 years of age.
IMPORTANT SAFETY INFORMATION
Do not use if you are allergic to dupilumab or to any of the ingredients in DUPIXENT®.
Before using DUPIXENT, tell your healthcare provider about all your medical conditions, including if you:
- have eye problems.
- have a parasitic (helminth) infection.
- are scheduled to receive any vaccinations. You should not receive a “live vaccine” right before and during treatment with DUPIXENT.
- are pregnant or plan to become pregnant. It is not known whether DUPIXENT will harm your unborn baby.
- A pregnancy registry for women who take DUPIXENT during pregnancy collects information about the health of you and your baby. To enroll or get more information call 1-877-311-8972 or go to https://mothertobaby.org/ongoing-study/dupixent/.
- are breastfeeding or plan to breastfeed. It is not known whether DUPIXENT passes into your breast milk.
Tell your healthcare provider about all the medicines you take, including prescription and over-the- counter medicines, vitamins, and herbal supplements.
Especially tell your healthcare provider if you are taking oral, topical, or inhaled corticosteroid medicines; have asthma and use an asthma medicine; or have atopic dermatitis, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, or prurigo nodularis and also have asthma. Do not change or stop your corticosteroid medicine or other asthma medicine without talking to your healthcare provider. This may cause other symptoms that were controlled by the corticosteroid medicine or other asthma medicine to come back.
DUPIXENT can cause serious side effects, including:
- Allergic reactions. DUPIXENT can cause allergic reactions that can sometimes be severe. Stop using DUPIXENT and tell your healthcare provider or get emergency help right away if you get any of the following signs or symptoms: breathing problems or wheezing, swelling of the face, lips, mouth, tongue or throat, fainting, dizziness, feeling lightheaded, fast pulse, fever, hives, joint pain, general ill feeling, itching, skin rash, swollen lymph nodes, nausea or vomiting, or cramps in your stomach-area.
- Eye problems. Tell your healthcare provider if you have any new or worsening eye problems, including eye pain or changes in vision, such as blurred vision. Your healthcare provider may send you to an ophthalmologist for an exam if needed.
- Inflammation of your blood vessels. Rarely, this can happen in people with asthma who receive DUPIXENT. This may happen in people who also take a steroid medicine by mouth that is being stopped or the dose is being lowered. It is not known whether this is caused by DUPIXENT. Tell your healthcare provider right away if you have: rash, chest pain, worsening shortness of breath, a feeling of pins and needles or numbness of your arms or legs, or persistent fever.
- Joint aches and pain. Some people who use DUPIXENT have had trouble walking or moving due to their joint symptoms, and in some cases needed to be hospitalized. Tell your healthcare provider about any new or worsening joint symptoms. Your healthcare provider may stop DUPIXENT if you develop joint symptoms.
The most common side effects include:
- Eczema: injection site reactions, eye and eyelid inflammation, including redness, swelling, and itching, sometimes with blurred vision, dry eye, cold sores in your mouth or on your lips, and high count of a certain white blood cell (eosinophilia).
- Asthma: injection site reactions, high count of a certain white blood cell (eosinophilia), pain in the throat (oropharyngeal pain), and parasitic (helminth) infections.
- Chronic Rhinosinusitis with Nasal Polyposis: injection site reactions, eye and eyelid inflammation, including redness, swelling, and itching, sometimes with blurred vision, high count of a certain white blood cell (eosinophilia), gastritis, joint pain (arthralgia), trouble sleeping (insomnia), and toothache.
- Eosinophilic Esophagitis: injection site reactions, upper respiratory tract infections, cold sores in your mouth or on your lips, and joint pain (arthralgia).
- Prurigo Nodularis: eye and eyelid inflammation, including redness, swelling, and itching, sometimes with blurred vision, herpes virus infections, common cold symptoms (nasopharyngitis), dizziness, muscle pain, and diarrhea.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of DUPIXENT. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.
Use DUPIXENT exactly as prescribed by your healthcare provider. It’s an injection given under the skin (subcutaneous injection). Your healthcare provider will decide if you or your caregiver can inject DUPIXENT. Do not try to prepare and inject DUPIXENT until you or your caregiver have been trained by your healthcare provider. In children 12 years of age and older, it’s recommended DUPIXENT be administered by or under supervision of an adult. In children 6 months to less than 12 years of age, DUPIXENT should be given by a caregiver.
Please see accompanying full Prescribing Information including Patient Information.
About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.
Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite®, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases.
For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn, Instagram, Facebook or X.
About Sanofi
We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people's lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.
Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY.
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This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. 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FAQ
What is the new FDA target action date for Dupixent in COPD?
Why did the FDA extend the review period for Dupixent in COPD?
Are there any concerns from the FDA regarding the approvability of Dupixent for COPD?
What were the pivotal trials involved in the Dupixent COPD submission?
Has Dupixent received a positive opinion from any other regulatory authority for COPD?
Is Dupixent fully approved for COPD treatment by any regulatory authority?
