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Gilead’s Hepatitis C Drug Submitted for FDA Review



Providing the treatment received agency approval, Gilead hopes to launch the sofosbuvir-velpatasvir therapy in 2016.

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October 30, 2015 | by Sarah Massey, M.Sc.

As Gilead Sciences’ two approved therapies for hepatitis C have been billion-dollar successes, the company plans to launch a third treatment option which could be more effective at treating a wider range of patients with the disease. Gilead has submitted a Food and Drug Administration (FDA) application for its combination therapy of Sovaldi (sofosbuvir) and velpatasvir – an experimental NS5A inhibitor.

The combination has proved effective across three Phase II clinical trials in treating patients infected with hepatitis C genotypes 1 to 6, and has cured 98 percent of patients in a 12 week period. As a further win for Gilead, the combination therapy was awarded the FDA’s breakthrough therapy designation.

Providing the treatment received agency approval, Gilead hopes to launch the sofosbuvir-velpatasvir therapy in 2016. At that time, the company will have extended its market share to three approved hepatitis C drugs.

Following its 2013 approval, Sovaldi ushered in a new treatment paradigm for hepatitis C. Traditionally, the viral infection was treated using painful interferon therapy.

In 2014, Gilead outdid themselves by launching Harvoni – a combination therapy consisting of sofosbuvir and ledipasvir – that is capable of curing genotype 1 hepatitis C in as little as 8 weeks. The Solaldi-velpatasvir combination therapy would add a broader-spectrum treatment for multiple hepatitis C genotypes to Gilead’s hepatitis C portfolio.

“Genotype 1 is the most prevalent form of HCV in the United States, but worldwide, more than half of people living with HCV are infected with other genotypes,” said Norbert Bischofberger, Gilead’s Chief Scientific Officer. “SOF/VEL (sofosbuvir and velpatasvir) complements our current HCV portfolio of Sovaldi and Harvoni, offering high cure rates and the potential to simplify treatment and eliminate the need for HCV genotype testing.”

While Gilead is staying strong with its hepatitis C offerings, a number of other pharmaceutical developers are edging into the territory. Last year AbbVie released their combination treatment which retains some market share thanks to their exclusive deals with payers.

Both Merck and Bristol-Myers Squibb are also working on their own hepatitis C treatments. If competitors are able to gain approval for their hepatitis C drugs, Gilead could experience pricing pressure.




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Keywords:  Hepatitis C, Virus, FDA


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