J&J, Medivir gain FDA OK for new hep C therapy simeprevir
Johnson & Johnson ($JNJ) and its partner Medivir ($MVIR) won a green light from the FDA late on Friday to begin marketing their hepatitis C drug simeprevir, which will now be sold as Olysio. The protease inhibitor is in the same class of drugs as Incivek and Victrelis, the two dominant therapies which will soon be pushed aside by a new wave of all-oral cocktails that will eliminate the need for interferon.
Simeprevir's big claim to fame is that it can expand the cure rate and cut the duration of treatment, reducing the amount of interferon that patients have to subject themselves to when they take either of the two current mainstays: Vertex's ($VRTX) Incivek or Merck's ($MRK) Victrelis.
Medivir won a €10 million milestone from J&J on the approval.
"Olysio is the third FDA-approved protease inhibitor to treat chronic hepatitis C virus infection, and provides health professionals and patients with a new, effective treatment for this serious disease," said Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research.
An FDA panel recently green-lighted the hep C treatment with its unanimous backing, offering doctors an alternative to what's available now. In Phase III studies the treatment wiped out the virus among 80% of patients, including 79% who had relapsed following other therapies.
But it won't be the preferred treatment once Gilead's ($GILD) sofosbuvir and the other all-orals arrive. Sofosbuvir is expected to get an OK in a matter of days, with a PDUFA date for early December. And then other drugs are following closely behind from AbbVie ($ABBV) and Bristol-Myers Squibb ($BMY).
- here's the FDA's release