The Food and Drug Administration approved the twice-a-day pill from Vertex Pharmaceuticals for a variation of cystic fibrosis that affects about 8,500 people in the US who are 12 years and older.
The approval notice was posted to the agency's website.
The new drug, to be sold as Orkambi (or-KAM-bee), is Vertex's follow-up to its breakthrough pill Kalydeco (kuh-LYE-deh-koh), which became the first drug to treat the underlying cause of cystic fibrosis in 2012.
