Vertex could snag 250 more Kalydeco patients with EMA nod

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. Now, the EMA could be poised to do the same: Friday, its European Committee for Medicinal Products for Human Use (CHMP) issued a recommendation for approval in that population for the pricey orpha drug. Vertex gets about $300,000 a year per patient for Kalydeco in the U.S. Release | More

Suggested Articles

The future may be uncertain for AZ’s Imfinzi in first-line lung cancer, but its targeted med Tagrisso now boasts a green light in that setting.

Ultragenyx is back with another FDA nod, this time for Crysvita to treat X-linked hypophosphatemia in patients one year and older.

Roche got a two pieces of good Hemlibra news early this week—and what's good for Hemlibra must be good for Roche.