Vertex Pharmaceuticals Reports Positive Phase 3 Results in Children for Blockbuster CF Drug
Vertex Pharmaceuticals' (NASDAQ: VRTX) blockbuster cystic fibrosis drug Trikafta might soon have a larger addressable market. The company announced Thursday that a phase 3 trial of the drug, in which it was administered to 6- to 11-year-old patients, met both its primary endpoint (for safety and tolerability) and several secondary endpoints.
The next stage, said Vertex, is for the company to file a supplemental New Drug Application (NDA) for patients in that age group, which it will do in the fourth quarter.
Trikafta was first approved by the Food and Drug Administration in October, but only for use in patients 12 and older -- hence the need for a supplemental NDA.
Source Fool.com
