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Gilead Gets European CHMP's Positive Opinion For Epclusa For All Genotypes of Chronic Hepatitis C Treatment

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Gilead Sciences, Inc. (NASDAQ: GILD) revealed that the Committee for Medicinal Products for Human Use (CHMP), European Medicines Agency's (EMA) Scientific Committee, has adopted a positive opinion on its Marketing Authorization Application (MAA) for Epclusa. According to the company, this is an investigational, pan-genotypic, once-daily tablet containing the nucleotide analogue polymerase inhibitor sofosbuvir (SOF) 400 mg and velpatasvir (VEL) 100 mg, an investigational pan-genotypic NS5A inhibitor, for chronic hepatitis C virus (HCV) infection treatment.

Gilead Sciences said the data included in the application supported the use of Epclusa (SOF/VEL) in adults with all genotypes (GT1-6) of HCV infection. The positive opinion of CHMP was adopted after an accelerated review procedure, reserved for medicinal products expected to be of big public health interest. The company indicated that the recommendation would now be reviewed by the European Commission as it has the sole authority to approve medicines for use in the 28 countries of the European Union, Norway and Iceland.

The drug maker also said it submitted a regulatory application for SOF/VEL in the United States. The company filed the NDA for SOF/VEL on October 28 last year, and the American Regulator has set a target action date under the Prescription Drug User Fee Act (PDUFA) of June 28. The company added that Epclusa is an investigational product and its safety, as well as, efficacy has not yet been established.

Gilead said that the MAA for Epclusa was supported by data from four Phase 3 studies, ASTRAL-1, ASTRAL-2, ASTRAL-3 and ASTRAL-4. In the ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, 1,035 patients with genotypes 1-6 HCV infection, without cirrhosis or with compensated cirrhosis (Child-Pugh A) received 12 weeks of Epclusa.

Posted-In: Biotech News FDA General

 

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