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FDA Grants Priority Review for Gilead's Sofosbuvir + Ledipasvir Coformulation

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The U.S. Food and Drug Administration (FDA) has agreed to expedited review of Gilead Science's sofosbuvir plus ledipasvir coformulation for treatment of chronic hepatitis C, putting the combination pill on track for an approval decision by mid-October, the company recently announced.

The FDA approved sofosbuvir (Sovaldi), a nucleotide HCV polymerase inhibitor, in December 2013. For people with HCV genotypes 2 or 3, or those with genotype 1 who cannot use interferon, sofosbuvir plus ribavirin is the first approved interferon-free option. Studies have shown that a coformulation of sofosbuvir plus the NS4A inhibitor ledipasvir is highly effective against HCV genotype 1. Adding a third experimental drug cured most people in only 6 weeks in the SYNERGY trial.

Below is an edited excerpt from a Gilead press release describing the FDA action.

Gilead Announces U.S. FDA Priority Review Designation for Ledipasvir/Sofosbuvir Fixed-Dose Combination Tablet for Chronic Hepatitis C Genotype 1 Infection

Final FDA Decision Anticipated by October 10, 2014

Foster City, Calif. -- April 7, 2014 -- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted priority review to the company’s New Drug Application (NDA) for a once-daily fixed-dose combination of the NS5A inhibitor ledipasvir (LDV) 90 mg and the nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400 mg for the treatment of chronic hepatitis C genotype 1 infection in adults. Gilead filed the NDA for LDV/SOF on February 10, 2014, and the FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of October 10, 2014.

The FDA has also assigned LDV/SOF a Breakthrough Therapy designation. The FDA grants Breakthrough Therapy designation and priority review status to investigational medicines that may offer major advances in treatment over existing options. The data submitted in the NDA are from three Phase 3 studies, ION-1, ION-2 and ION-3, and support the use of LDV/SOF in adults with genotype 1 HCV infection, with a treatment duration of eight or 12 weeks depending on prior treatment history and whether they have cirrhosis. Approximately 75 percent of people infected with HCV in the United States have the genotype 1 strain of the virus.

A marketing application for LDV/SOF is also under review in the European Union, and was validated by the European Medicines Agency (EMA) on March 27, 2014. The agency has accepted Gilead’s request for accelerated assessment of LDV/SOF, a designation that is granted to new medicines of major public health interest. If accepted, accelerated assessment could shorten the EMA’sreview time of LDV/SOF by two months, although it does not guarantee a positive opinion from the Committee for Medicinal Products for Human Use or approval by the European Commission.

LDV/SOF is an investigational product and its safety and efficacy have not yet been established.

SOF as a single agent was approved by the FDA under the tradename Sovaldi on December 6, 2013 and by the European Commission on January 17, 2014.

About Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North and South America, Europe and Asia Pacific.

U.S. full prescribing information for Sovaldi is available at www.gilead.com

For more information on Gilead Sciences, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

4/9/14

Source

Gilead Sciences. Gilead Announces U.S. FDA Priority Review Designation for Ledipasvir/Sofosbuvir Fixed-Dose Combination Tablet for Chronic Hepatitis C Genotype 1 Infection. Press release. April 7, 2014.