Lundbeck's epilepsy med approved, J&J's rejected

Shares of Lundbeck are on the rise today on the news that the FDA has approved the drugmaker's anti-epilepsy drug Sabril. The drug, which received the FDA nod as a monotherapy on Friday, is the first approved for the treatment of infantile spasms in children aged one month to two years. Infantile spasms is a rare disease that causes hundreds of spasms per day and kills as many as 20 percent of its victims. Sabril was also cleared as a second-line treatment for adults with complex partial seizures.

Lundbeck said it will launch the drug this quarter. Sabril will carry a boxed warning regarding the risk of permanent vision loss associated with the drug, the company said in a statement. The drugmaker plans to closely monitor its patients by restricting the drug's distribution, as well as requiring that all patients undergo a vision test and mandatory risk-benefit assessment. The drug, which Lundbeck acquired along with Ovation Pharmaceuticals (now Lundbeck Inc.) earlier this year, is already approved in Canada and Europe. Lundbeck is also seeking the FDA's approval to market Sabril as an addiction treatment.

Johnson & Johnson's experimental epilepsy drug Comfyde (carisbamate) failed to gain the agency's backing. J& sought approval, on behalf of its subsidiary, Ortho-McNeil-Janssen Pharmaceuticals, to market the drug as an adjunctive treatment for partial onset seizures in patients aged 16 years and over. J&J said it is reviewing the FDA's letter and will respond as quickly as possible, but the drugmaker has offered no further details or comment.

- here's the Lundbeck release
- read the J&J release
- more on the development of Sabril from LA Times Blog