Arkansas Medicaid officials have wrapped up a legal dispute over Vertex's cystic fibrosis drug Kalydeco, settling to resolve claims the state denied patients the treatment based on its high price tag. And while it's good news for the drugmaker, this may be just the first in a series of cost-control battles to follow.
Vertex is already awaiting the FDA's decision on a Kalydeco combo that could exponentially amp up its cystic fibrosis patient pool. But in the meantime, it announced Sunday evening, it's starting in on a Phase III program for yet another Kalydeco pairing.
Vertex will start the new year with a group of new eligible patients for cystic fibrosis drug Kalydeco, thanks to a Monday green light from the FDA. The agency has OK'd the med in patients with the R117H mutation, a nod analysts say will boost Kalydeco in the present and also bodes well for its future.
Despite falling short of its primary endpoint in a trial to examine its effects in cystic fibrosis patients with the R117H mutation, Vertex's Kalydeco has scored an FDA advisory committee recommendation for approval in that population. And the way some see it, that's a sign of much, much bigger approvals to come.
Vertex' orphan drug Kalydeco boasts a comparatively small patient pool that the drugmaker is trying to swell, with an eye on adding cystic fibrosis patients with the R117H mutation. But first, it'll have to get the FDA's OK, and new briefing documents suggest the agency still has some doubts.
Just three years after nabbing the "fastest drug launch ever" award, Vertex is discontinuing hepatitis C med Incivek on withering demand, it said in a recent letter to healthcare providers.
Bye-bye, Incivek. Just three years after nabbing the "fastest drug launch ever" award, maker Vertex is discontinuing the hepatitis C med on withering demand. For that, the Cambridge-based company has Gilead Sciences--owner of the new fastest drug launch ever--to thank.
Vertex' patient pool for cystic fibrosis drug Kalydeco is getting wider--250 patients wider, to be specific. The European Medicines Agency has green-lighted the drug--originally approved for CF patients with at least one copy of the G551D mutation--for 8 additional mutations, spelling new revenue potential for the orphan drugmaker.
Back in February, the FDA green-lighted Kalydeco to treat cystic fibrosis in patients with one of 8 distinct gating mutations, dramatically swelling the orphan drug's patient pool.
Biotech Vertex has pulled the plug on work in the hepatitis C arena, an area it was expected to dominate with its Incivek until Gilead Sciences redefined the category with Sovaldi, a drug now expected to become the top seller of all time.