RedHill Biopharma’s Talicia Received the US FDA’s Approval for H. pylori in Adults

 RedHill Biopharma’s Talicia Received the US FDA’s Approval for H. pylori in Adults

Shots:

  • The approval is based on two P-III study results assessing Talicia vs active comparator arm and resulted in eradication of H. pylori infection (84% vs 58%), response rate @13 day (90.3% vs 64.7%), No resistance to rifabutin
  • Talicia has market exclusivity of 8 years in the US under QIDP designation in addition to patent protection extending until 2034
  • Talicia is a combination of two antibiotics amoxicillin and rifabutin and a PPI (omeprazole magnesium) is a delayed-release capsules 10 mg1/250 mg/12.5 mg with fixed-dose approved in the US for H. pylori infection in adults, with expected launch in Q1’20

Click here to­ read full press release/ article | Ref: GlobeNewswire | Image: Twitter

Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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