RedHill Announces FDA sNDA Approval for Talicia®
- Talicia is the leading branded first-line therapy for H. pylori eradication
- Talicia's favorable efficacy, tolerability, and resistance profile provide potential advantages
- None.
FDA approves supplemental new drug application (sNDA) for Talicia, changing dosing to a simplified three times daily (TID) regimen, which may support increased patient adherence and treatment outcomes
Talicia is the leading branded first-line therapy prescribed by
"H. pylori treatment can be challenging for patients as most regimens require different pills to be taken multiple times per day. However, it is clear that simplified regimens promote improved patient adherence and should be a key factor when considering choice of H. pylori eradication therapy," said Colin W. Howden, MD, Professor Emeritus, University of
"Talicia is unique in that it is the only FDA-approved rifabutin-based therapy for the eradication of H. pylori. Both its components and formulation are optimized to provide patients with the necessary medications for successful H. pylori eradication," said Dr. June Almenoff, MD, Ph.D., RedHill's Chief Medical Officer. "RedHill is committed to advancing GI and infectious disease management through patient-focused innovation. Through our successful collaboration with Certara, utilizing their Simcyp™ Simulator for physiologically based pharmacokinetic (PBPK) modeling, we have demonstrated therapeutic equivalence between TID and Q8H dosing, enabling us to provide what we believe is a more flexible Talicia regimen that we believe will be beneficial for the patient experience."
About H. pylori infection
H. pylori is a bacterial infection that affects approximately
About Talicia
Talicia is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (PPI) (omeprazole), approved by the
Talicia is the only low-dose rifabutin-based therapy approved for the treatment of H. pylori infection and is designed to address H. pylori's high resistance to other antibiotics. The high rates of H. pylori resistance to clarithromycin have led to significant rates of treatment failure with clarithromycin-based therapies and are a strong public health concern, as highlighted by the ACG, FDA and the World Health Organization (WHO) in recent years.
In the pivotal Phase 3 study, Talicia demonstrated
Talicia is eligible for a total of eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation and is also covered by
TALICIA: IMPORTANT SAFETY INFORMATION
Tell your healthcare provider about all of the medicines you take, including prescription or non-prescription medications or herbal supplements before starting Talicia. Talicia may affect the way other medicines work, and other medicines may affect the way Talicia works. Do not start any new medications while taking Talicia without first speaking with your healthcare provider.
- You should not take Talicia if you are known to be sensitive to any of the components of Talicia (omeprazole, amoxicillin, rifabutin), penicillins, proton pump inhibitors or rifamycins.
- You should not take Talicia if you are taking rilpivirine-containing products, delavirdine or voriconazole.
Before you take Talicia, tell your healthcare provider about all of your medical conditions, including if you:
- Are pregnant or plan to become pregnant. Talicia may harm your unborn baby. Tell your healthcare provider if you become pregnant or think you may be pregnant during your treatment with Talicia.
- Have severe kidney disease or liver disease.
When taking Talicia, do not crush or chew capsules. Do not take Talicia with alcohol.
Call your healthcare provider immediately if while taking Talicia you develop:
- New rash or other skin changes, muscle or joint pains, swelling of any area of the body, severe flu-like symptoms, difficulty breathing, fever, blood in your urine, increased or decreased urination, drowsiness, confusion, nausea, vomiting, ongoing stomach pain, bloody diarrhea, or if diarrhea continues after therapy is completed, weight gain or changes in your eyesight.
What are the common side effects of Talicia?
- The most common side effects of Talicia are diarrhea, headache, nausea, stomach pain, rash, indigestion, mouth or throat pain, vomiting, and vaginal yeast infection. Call your healthcare professional for medical advice about side effects.
- Tell your healthcare provider if you experience tiredness, weakness, achiness, headaches, dizziness, depression, increased sensitivity to light, or pain when taking a deep breath.
- Talicia may reduce the effectiveness of oral or other forms of hormonal birth-control. You should use an additional non-hormonal highly effective method of birth control while taking Talicia.
- You may experience a brown-orange discoloration of your urine or tears while taking Talicia.
- The information here is not comprehensive. Talk to your healthcare provider to learn more.
APPROVED USE FOR TALICIA
TALICIA is indicated for the treatment of Helicobacter pylori infection in adults.
Click here for the full Prescribing Information for TALICIA.
You are encouraged to report Adverse Reactions to RedHill Biopharma Inc. at 1-833-ADRHILL (1-833-237-4455) or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
About RedHill Biopharma
RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs Talicia®, for the treatment of Helicobacter pylori (H. pylori) infection in adults[11], and Aemcolo®, for the treatment of travelers' diarrhea in adults[12]. RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640), a first-in-class oral broad-acting, host-directed SPHK2 selective inhibitor with potential for pandemic preparedness, targeting multiple indications with a
More information about the Company is available at: www.redhillbio.com / twitter.com/RedHillBio.
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties, including without limitation the risk that the Company will not succeed to expand Talicia's reach to additional ex-
Company contact: Adi Frish Chief Corporate & Business Development Officer RedHill Biopharma +972-54-6543-112 |
Category: Commercial
[1] IQVIA XPO Data on file
[2] Hooi JKY et al. Global Prevalence of Helicobacter pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology 2017; 153:420-429.
[3] Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: www.Talicia.com.
[4] IQVIA Custom Study for RedHill Biopharma, 2019
[5] Lamb A et al. Role of the Helicobacter pylori–Induced inflammatory response in the development of gastric cancer. J Cell Biochem 2013;114.3:491-497.
[6] NIH – Helicobacter pylori and Cancer, September 2013.
[7] Hu Q et al. Gastric mucosa-associated lymphoid tissue lymphoma and Helicobacter pylori infection: a review of current diagnosis and management. Biomarker research 2016;4.1:15.
[8] National Cancer Institute, Surveillance, Epidemiology, and End Results Program (SEER).
[9] Defined as the PK population which included those subjects in the ITT population who had demonstrated presence of any component of investigational drug at visit 3 (approx. day 13) or had undetected levels drawn >250 hours after the last dose.
[10] The pivotal Phase 3 study with Talicia® demonstrated
[11] Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: www.Talicia.com.
[12] Aemcolo® (rifamycin) is indicated for the treatment of travelers' diarrhea caused by noninvasive strains of Escherichia coli in adults. For full prescribing information see: www.aemcolo.com.
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SOURCE RedHill Biopharma Ltd.