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Gilead gets OK for three-in-one hep C therapy in US

FDA clears the new product for the most common HCV genotypes

GileadThe US FDA has approved Gilead Sciences' triple drug therapy Vosevi to treat hepatitis C Virus (HCV) as a back-up therapy for patients who can't eliminate the virus with current drugs.

The single-tablet triple therapy contains NS5B polymerase inhibitor sofosbuvir and NS5A inhibitor velpatasvir - the two active ingredients in Gilead's recently-approved two-drug HCV combination Epclusa - as well as a new pan-genotypic protease inhibitor called voxilaprevir.

The FDA has cleared the new product for all the most common HCV genotypes (1-6) in patient without or with mild cirrhosis, saying in a statement that Vosevi is "the first treatment approved for patients who have been previously treated with the direct-acting antiviral drug sofosbuvir or other drugs for HCV that inhibit a protein called NS5A".

Other NS5A inhibitors on the market for HCV include Gilead's ledipasvir, Bristol-Myers Squibb's daclatasvir, AbbVie's dasabuvir and Merck & Co's elbasvir. The approval is believed to be the first for voxilaprevir anywhere in the world.

Gilead said the new product completes its range of sofosbuvir-based directly-acting antiviral (DAAs) for hepatitis C that offer people living with HCV a short course of therapy to cure their infection with a single-tablet, once-daily dose, and has previously been described by CEO John Milligan as "the end of what we'll be developing in terms of HCV molecules".

Hepatitis specialist Ira Jacobson of Mount Sinai Beth Israel, New York City, who led the Vosevi trials, said: "DAA regimens have transformed HCV treatment and have allowed health care providers the fortunate opportunity to cure many patients.

"However, for patients who require re-treatment, there remains an unmet clinical need for an effective and well-tolerated option."

The US biotech has made tens of billions of dollars from its HCV portfolio since it launched Sovaldi (sofosbuvir) to great fanfare in 2013, but the DAA therapies have fallen victim to their own success. They have been so effective in eradicating the virus in a short treatment timeframe that the pool of available patients for therapy is in decline - along with Gilead's HCV revenues.

Latterly, efforts have been made to develop combination regimens that are as short as possible, less costly and better-tolerated.

Sovaldi and follow-ups Harvoni and Epclusa are still pulling in big bucks for Gilead - adding $2.6bn to its revenues in the first quarter of this year - but were down from a $4.3bn in the first quarter of 2016. The company is now turning its attention to other R&D targets - notably chronic non-viral liver disease, cancer and inflammation.

Gilead has also filed for the sofosbuvir, velpatasvir and voxilaprevir therapy in the EU, winning an accelerated review from the EMA in January.

Article by
Phil Taylor

19th July 2017

From: Regulatory

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