San Diego-based Ligand Pharmaceuticals had plenty to cheer about after European regulators approved Pfizer's application to sell Fablyn to women with weak bones.
The regulatory win at the European Commission comes just two months after Fablyn failed to win approval by the FDA. The agency wants more data on the osteoporosis drug, with U.S. regulators concerned about deaths recorded among patients taking the drug in a clinical trial. An advisory group at the FDA had recommended an approval last September, though, noting that the drug's benefits most likely outweighed any risks.
Ligand wins a $3 million milestone payment on the approval in Europe and royalties on any sales. And Pfizer-which has worldwide commercialization rights--says it will now look for a partner to commercialize the therapy.
"Today's announcement is an exciting development for Ligand as the European approval of Fablyn marks the fourth drug associated with Ligand's research platform that has been approved and the second to be approved in just the past six months," said Ligand CEO John Higgins.
- read the press release