Oct 25, 2013, 2:49pm PDT Updated: Oct 25, 2013, 3:05pm PDT
Gilead's Norbert Bischofberger: Sofosbuvir is aimed at curing hepatitis C.
Ron Leuty
Reporter- San Francisco Business Times
A kinder, gentler hepatitis C treatment from Gilead Sciences Inc. — seen as a potential cure for the debilitating and deadly liver disease — was green-lighted Friday by an FDA advisory panel.
The Food and Drug Administration isn't required to follow the committee's recommendation — which was unanimous in this case — but often does. What's more, FDA staff gave the drug, called sofosbuvir, a favorable review earlier this week.
The FDA is expected to approve the drug — actually a once-a-day combination of sofobuvir with antiviral ribavirin in adults with chronic hepatitis C with genotype 2 and 3 infection — by Dec. 8.
Foster City-based Gilead (NASDAQ: GILD) acquired the drug as part of its $11 billion January 2011 buyout of Pharmasset Inc. But the initial use of the drug is only the first step toward a crucial one-pill oral cure for the leading cause of liver cancer. Gilead is working on a combination of sofoxbuvir and another drug it is developing, called ledipasvir, that targets the largest subset of hepatitis C patients.
Gilead, led by CEO John Martin, hopes to follow up that with another once-daily combination, called GS-5816, aimed at obliterating the virus in all hepatitis C patients.
"This could potentially eliminate hepatitis C from the face of the earth," Gilead Chief Scientific Officer Norbert Bischofberger told the San Francisco Business Times earlier this year.
Gilead has faced criticism from some patients and their advocates, however, because it opted not to work with Bristol-Myers Squibb, Pharmasset's one-time partner.
Gilead also is seeking approval of sofosbuvir in the European Union, Canada, Australia, New Zealand, Switzerland and Turkey.
Sofosbuvir is part of a new class of hepatitis C treatments — nicknamed "nucs" — that block a specific enzyme of the virus. Besides stunning cure rates from clinical trials, nucs are important because they could shift patients from today's treatment of weekly injections of interferon and ribavirin to an all-oral cure.
An easily dosed cure, Gilead and others say, would increase the number of patients who stay on therapy. The interfron-ribavirin treatment is so brutal, they say, that only about half of patients who start therapy continue with it.
"One argument for not collaborating is, if you do it yourself, you can move faster," Bischofberger told the Business Times earlier this year. "Patients will benefit from this single pill much sooner than in a collaboration."
Gilead stock closed down 15 cents to $69.68 per share, near its 52-week high of $70.30.
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