Denmark’s Lundbeck has received the backing of US health regulators to market Sabril to treat infantile spasms in children and certain types of epileptic seizures in adults.

Specifically, the US Food and Drug Administration has approved Sabril (vigabatrin) as a monotherapy to treat infantile spasms in children aged one month to two years, the first drug to be approved for that indication across the Atlantic. The treatment has also been given the green light for the 30%-36% of adults with complex partial seizures who have not responded adequately to other antiepileptic therapies.

Lundbeck says it plans to launch Sabril, which it got hold of through its acquisition of Ovation Pharmaceuticals earlier this year, during the third quarter of 2009. The firm noted that the launch will come with an extensive risk evaluation and mitigation strategy programme “to manage the risk of permanent vision loss associated with the product”.

The REMS, which was “a critical component in receiving FDA approval”, Lundbeck acknowledged, involves restricted product distribution, requires vision testing and mandatory risk-benefit assessments. Sabril will also carry a boxed warning about the risk of “a progressive loss of peripheral vision with potential decrease in visual acuity”.

CRL for J&J’s carisbamate
Meantime, the FDA has sent a complete response letter to Johnson & Johnson about its investigational epilepsy drug Comfyde (carisbamate).

J&J's Ortho-McNeil-Janssen Pharmaceuticals division is hoping to get approval for carisbamate for the adjunctive treatment of partial onset seizures who are 16 years of age and over. The company declined to reveal any details about the contents of the letter and limited itself to saying that it will “respond to the agency's questions as quickly as possible”.