Sofosbuvir Is Waiting for Green Light
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Regulators Await Gilead’s Hep C Candidate
Feb 21 2013
Gilead Sciences’ (GILD) sofosbuvir has passed all its preliminary examinations, and now is looking like a good bet for regulatory submissions in the coming months. The last of four phase III trials in combination with one or both of the mainstays of current hepatitis C treatment has met its primary endpoint, likely providing sufficient data to support approval in combination therapy in the six major genotypes of the virus.
The pivotal data leave the California company tantalisingly close to reaching the holy grail of hep C treatment: an all-oral treatment that removes interferon and ribavirin – and their associated side effects – from the treatment regimen. With filing of the fixed-dose combination with GS-5885 not expected until next year, a limited approval of sofosbuvir should help Gilead begin to earn back the $11bn it spent to acquire the candidate.
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