Looks like you’re on the UK site. Choose another location to see content specific to your location

Home Industry News Gilead Sciences files for US approval of new hepatitis drug

Gilead Sciences files for US approval of new hepatitis drug

12th February 2014

Gilead Sciences' new combination therapy for hepatitis C has reached a new regulatory milestone with the filing of a new drug application with the US Food and Drug Administration (FDA).

The company is seeking US approval of a once-daily fixed-dose combination of the NS5A inhibitor ledipasvir 90 mg and the nucleotide analog polymerase inhibitor sofosbuvir 400 mg for the treatment of chronic hepatitis C genotype 1 infection in adults.

Based on the positive safety and efficacy data from three phase III trials and the potentially significant advances it offers over currently available options, the new treatment has received a breakthrough therapy designation from the FDA.

Gilead plans to file for approval of the drug combination in other territories such as Europe in the first quarter of 2014. An application has already been submitted to the European Medicines Agency for accelerated assessment of the therapy.

Dr Norbert Bischofberger, executive vice-president of research and development and chief scientific officer at Gilead, said: "Today's filing brings us one step closer to our goal of offering all patients with hepatitis C a simple, safe and highly effective all-oral treatment regimen."

Sofosbuvir is available as a single agent under the trade name Sovaldi. It was approved for use in the treatment of hepatitis C genotypes 1-4 in Europe last month.ADNFCR-8000103-ID-801692663-ADNFCR

We currently have 10 jobs available in Pharmacy industry, find your perfect one now.

Stay informed

Receive the latest industry news, Tips
and straight to your inbox.