J&J wins FDA panel blessing for hep C blockbuster hopeful
Johnson & Johnson's ($JNJ) much-hyped simeprevir picked up the unanimous support of FDA advisers on Thursday, moving the potential hepatitis C blockbuster one step closer to market as a who's who of drug developers advances next-generation therapies.
The agency's Antiviral Drugs Advisory Committee voted 19-0 in favor of approving simeprevir, an NS3/4A protease inhibitor that promises to treat the most common genotype of chronic hepatitis C, standing out amid a new class of combo treatments angling for entry into the huge market. The committee's recommendation applies to a capsule containing the compound combined with pegylated interferon and ribavirin, but much of the excitement over simeprevir and its in-development competitors stems from their potential to be used in interferon-free cocktails.
The drug, developed alongside partner Medivir, won a priority review from the FDA in May, and while the agency is not beholden to the advice of its committees, a unanimous recommendation makes full approval more than likely. In parsing simeprevir's data, FDA investigators noted that hep C patients with a certain polymorphism variant were less likely to benefit from the drug, but, considering the panel's final vote, the issue is apparently not a major demerit.
The panel's recommendation of simeprevir is based on three Phase III studies in which J&J's drug cured about 80% of treatment-naive hep C patients and roughly 79% of those who had relapsed after earlier interferon-based treatment.
J&J's success sets the table for rival Gilead Sciences ($GILD) and its class-leading sofosbuvir, which is due before the same panel Friday. Sofosbuvir is widely expected to become the brightest star among the new generation of hep C therapies, which also includes offerings from AbbVie ($ABBV) and Bristol-Myers Squibb ($BMY).
- read J&J's statement
FDA gives J&J a thumbs-up--with a catch--on hep C drug simeprevir
J&J's hep C drug simeprevir gets inside track at the FDA
Gilead's sofosbuvir cures some of the toughest hepatitis C cases