Federal regulators have expanded US approval of a Vertex Pharmaceuticals Inc. cystic fibrosis drug, making it available to more than 900 new patients age 2 and over with specific genetic mutations.
The Boston biotech said Wednesday that said the Food and Drug Administration OK’d the use of Kalydeco in patients who each have one of 23 so-called residual function mutations in a cystic fibrosis regulator gene. The company, based in Boston, also said it was talking to FDA officials about using the medicine to treat more than 600 other patients with one of five different mutations.
Kalydeco was first approved five years ago for a narrower set of patients.
“We will continue to work closely with the FDA to bring Kalydeco to more people with responsive mutations who are still in need as rapidly as possible,” Vertex chief medical officer Jeffrey Chodakewitz said in a statement.
Vertex announced the FDA approval after financial markets closed Wednesday. The company’s shares were up about 1 percent in after-market trading.Robert Weisman can be reached at firstname.lastname@example.org. Follow him on Twitter @GlobeRobW.