Vertex Wins FDA Panel’s Recommendation for New Hepatitis C Drug
Vertex Pharmaceuticals’ bid for FDA approval of its new drug for hepatitis C has been treated by most observers as a slam dunk, and the company, as expected, nailed its high percentage shot on goal today.
Cambridge, MA-based Vertex (NASDAQ: VRTX) received a unanimous 18-0 endorsement from an FDA advisory panel, which said the company’s new telaprevir thrice-daily pill deserves a spot on the U.S. market. The FDA, which usually follows the advice of its panels, is scheduled to make its final determination by May 23.
Advisors to the FDA weighed the evidence today, which said that cure rates for the chronic liver infection shot up from 40 percent to almost 80 percent when the Vertex treatment was added to a regimen of two standard therapies, as noted by Matthew Perrone of the Associated Press. Panelists paid close attention to side effects of the new drug—primarily rash—although they said the issue could be managed by educating patients and doctors through materials and a toll-free hotline.
If Vertex goes on to win FDA approval of the new drug, it will be in position to change the standard of care for a virus that infects about 3 million people in the U.S. Analysts have forecast the drug could generate more than $2 billion a year in U.S. sales within a couple years.
“Hepatitis C is a curable disease with potentially devastating consequences if left untreated, so we are pleased by the committee’s unanimous recommendation to approve telaprevir for a broad group of people with hepatitis C,” said Peter Mueller, Vertex’s chief scientific officer, in a statement. “We look forward to working with the FDA as it prepares to make its decision next month.”
The FDA’s antiviral drug advisory committee also endorsed a competing hepatitis C drug from Merck yesterday, by the same 18-0 vote. Panelists today, according to Perrone, talked about how Vertex’s treatment offered cures to a higher percentage of patients than the Merck drug did, and the opportunity to shorten courses of treatment by half. Shortening the duration of therapy is important, because it means patients will have to endure less of the flu-like symptoms that are associated with the two standard meds.