The US Food and Drug Administration (FDA) has granted priority review to Gilead Sciences‘ new drug application (NDA) for a once-daily fixed-dose combination of the NS5A inhibitor ledipasvir (LDV) 90mg and the nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400mg for the treatment of adult patients with chronic hepatitis C genotype 1 infection.

The company filed the NDA for LDV/SOF in February, and the FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of 10 October 2014.

Previously, the FDA granted LDV/SOF a breakthrough therapy designation, which is given to investigational medicines that may provide major advances in treatment compared with existing options.

The NDA is based on data secured from three Phase III trials, ION-1, ION-2 and ION-3, which support the use of LDV/SOF in patients with genotype 1 HCV infection, with treatment duration of eight or 12 weeks depending on prior treatment history and whether they have cirrhosis.

"In the US, more than 75% of people infected with HCV have the genotype 1 strain of the virus."

In the US, more than 75% of people infected with HCV have the genotype 1 strain of the virus.

A marketing application for the combination therapy is also under review in the European Union (EU), and was validated by the European Medicines Agency (EMA) in March.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The EMA has accepted the company’s request for accelerated assessment of LDV/SOF, which if granted, will reduce the EMA’s review time of the combination drug by two months. But it does not guarantee a positive opinion from the Committee for Medicinal Products for Human Use or approval by the European Commission (EC).

SOF as a single agent was approved by the US FDA under the tradename Sovaldi in December 2013 and by the EC in January 2014.

Image: FDA priority review for Gilead’s hepatitis C combination therapy. Photo: courtesy of Freedigitalphotos.net.