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FDA clears Gilead’s Sofosbuvir in HCV; Simeprevir combo ‘door open’?

By Randy Osborne
Staff Writer

As expected, the FDA approved Gilead Sciences Inc.’s Sovaldi (sofosbuvir) 400 mg tablets, a once-daily oral nucleotide analog polymerase inhibitor for chronic hepatitis C virus, as part of a combination antiviral treatment regimen.

Sovaldi, hailed as one of the more promising HCV therapies to come down the pike in recent years, proved its efficacy in subjects with genotypes 1, 2, 3 or 4 infection, including those with hepatocellular carcinoma meeting the Milan criteria (awaiting liver transplantation) and those with HCV/HIV-1 co-infection.

The FDA-recommended regimens and treatment durations for Sovaldi vary according to genotype: 1 and 4 should get Sovaldi plus ribavirin and peg-interferon alfa for 12 weeks; genotype 2 should get the drug along with ribavirin for 12 weeks; and genotype 3 should be given the Sovaldi-ribavirin regimen for 24 weeks. U.S. regulators approved the compound under priority review and gave it breakthrough status.

Foster City, Calif.-based Gilead said almost 3,000 patients so far have received at least one dose of Sovaldi in Phase II or Phase III studies, and it’s been well tolerated. Adverse events were mild, with few treatment discontinuations.

The drug is moving forward in Europe, too. Last month, the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion on Gilead’s application for marketing authorization for Sovaldi. The opinion was adopted following an accelerated review procedure, a path saved for drugs expected to be of major public health interest. If approved, Sovaldi could be available in the European Union in the first quarter of 2014.

Gilead also has applications pending in Australia, Canada, New Zealand, Switzerland and Turkey.

Medivir AB pocketed a €10 million (US$13.5 million) milestone from partner Johnson & Johnson following the FDA approval of its hepatitis C virus (HCV)

The FDA’s approval late last month of the HCV protease inhibitor Olysio (simeprevir) from New Brunswick, N.J.-based Johnson & Johnson – an action that triggered a €10 million (US$13.5 million) milestone payment to partner Medivir AB, of Huddinge, Sweden – could bode well for Sovaldi as well, wrote Wells Fargo analyst Brian Abrahams in a research report.

“Perhaps most interestingly, the [Olysio] indication statement is broader than we had anticipated – for HCV treatment ‘as a component of a combination antiviral treatment regimen,’” Abrahams wrote. “The label goes on to say that efficacy for the agent has only been ‘established’ in combination with peg-interferon alfa/ribavirin; still, we believe this language should leave a wider door open for payers to support use of the agent in an all-oral combo with sofosbuvir.”