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Talicia FDA Approval History

Reviewed by J.Stewart BPharm. Last updated on Nov 4, 2019.

FDA Approved: Yes (First approved November 4, 2019)
Brand name: Talicia
Generic name: amoxicillin, omeprazole and rifabutin
Dosage form: Delayed-Release Capsules
Company: RedHill Biopharma Ltd.
Treatment for: Helicobacter Pylori Infection

Talicia (omeprazole magnesium, amoxicillin and rifabutin) is a fixed-dose combination of two antibiotics, (amoxicillin and rifabutin) and a proton pump inhibitor (omeprazole) for the treatment of Helicobacter pylori (H. pylori) infection.

  • H. pylori is classified as a Group I carcinogen and is considered a significant risk factor for the development of gastric cancer. H. pylori infection affects approximately 35% of the U.S. population and is also a major cause of peptic ulcer and gastritis.
  • Treatment of H. pylori infection has become increasingly difficult over the past decade due to bacterial resistance and diminished efficacy of clarithromycin-based standard-of-care therapies. Talicia is the first and only FDA approved rifabutin-based H. pylori therapy. It is designed to address the problem of growing H. pylori resistance to clarithromycin.
  • FDA approval of Talicia approval is based, in part, on the results of two positive Phase 3 studies in H. pylori-positive adult patients complaining of epigastric pain and/or discomfort. The ERADICATE Hp2 confirmatory Phase 3 study of Talicia demonstrated 84% eradication of H. pylori infection with Talicia versus 58% in the active comparator (amoxicillin and omeprazole) arm (p<0.0001).
  • Common adverse reactions include diarrhea, headache, nausea, abdominal pain, chromaturia (abnormal coloration of the urine), rash, dyspepsia, oropharyngeal pain (sore throat), vomiting, and vulvovaginal candidiasis (yeast infection).

Development Timeline for Talicia

DateArticle
Nov  4, 2019Approval FDA Approves Talicia (omeprazole magnesium, amoxicillin and rifabutin) for the Treatment of H. pylori Infection in Adults
Jul  3, 2019RedHill Biopharma Announces FDA Acceptance of New Drug Application for Talicia
May  7, 2019RedHill Biopharma Submits New Drug Application for Talicia for H. pylori Infection
Dec  3, 2018RedHill Announces Positive Top-Line Results from Confirmatory Phase 3 Study with Talicia for H. pylori Infection

Further information

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