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Gilead Requests FDA Approval of Sofosbuvir/ Ledipasvir Hep C Combo

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Gilead Sciences announced this week that it has filed for U.S. Food and Drug Administration (FDA) approval of a new fixed-dose coformulation containing its recently approved HCV polymerase inhibitor sofosbuvir (Sovaldi, formerly GS-7977) plus its NS5A inhibitor ledipasvir (formerly GS-5885) for interferon-free treatment of genotype 1 chronic hepatitis C.

As previously reported, the sofosbuvir/ledipasvir coformulation, with or without ribavirin, has demonstrated sustained response rates of 90% to 100% in the Phase 2 ELECTRON and LONESTAR trials and the Phase 3 ION trials. High cure rates have been obtained for treatment-naive patients and previous non-responders, including difficult-to-treat patients with HCV subtype 1a and liver cirrhosis.

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

Gilead Files for U.S. Approval of Ledipasvir/Sofosbuvir Fixed-Dose Combination Tablet for Genotype 1 Hepatitis C

-- If Approved, Fixed-Dose Combination Would be First Oral Treatment Regimen for Patients with Genotype 1 HCV Infection, Eliminating Need for Both Interferon and Ribavirin

Foster City, Calif. -- February 10, 2014 -- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) 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. The data submitted in the NDA support the use of LDV/SOF in patients with genotype 1 hepatitis C virus (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.

"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," said Norbert Bischofberger, PhD, Executive Vice President of Research and Development and Chief Scientific Officer. "Based on the data from the Phase 3 ION studies, the LDV/SOF combination may have the potential to cure HCV in genotype 1 patients in as little as eight weeks and without the need for interferon injections or ribavirin."

The FDA has assigned LDV/SOF a Breakthrough Therapy designation, which is granted to investigational medicines that may offer major advances in treatment over existing options. The NDA for LDV/SOF is supported by three Phase 3 studies, ION-1, ION-2, and ION-3, in which nearly 2,000 genotype 1 HCV patients were randomized to receive the fixed-dose combination, with or without RBV, for treatment durations of eight, 12, or 24 weeks. Trial participants included patients who were treatment-naive or who had failed previous treatment, including protease inhibitor-based regimens, and also included patients with compensated cirrhosis.

Gilead plans to file for regulatory approval of LDV/SOF in other geographies, including the European Union, in the first quarter of 2014. Gilead has submitted an application to the European Medicines Agency (EMA) for accelerated assessment of LDV/SOF, a designation that is granted to new therapies and medicines of major public health interest. If accepted, accelerated assessment could shorten the EMA’s review 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 has not yet been established.

SOF as a single agent was approved by the FDA under the trade name 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.

2/11/14

Source

Gilead Sciences. Gilead Files for U.S. Approval of Ledipasvir/Sofosbuvir Fixed-Dose Combination Tablet for Genotype 1 Hepatitis C. Press release. February 10, 2014.