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 [1] (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 [2]
- read the J&J release [3]
- more [4] on the development of Sabril from LA Times Blog

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Lundbeck to buy Ovation in $900M deal [1]