Lundbeck announces Sabril approval

Lundbeck has revealed that the Food and Drug Administration (FDA) has approved Sabril (vigabatrin) – marking the first-ever time the body has endorsed a treatment for infantile spasms.

In total, two drug application approvals have been granted to Lundbeck for Sabril tablets and an oral variation. Both are scheduled to be launched in the third quarter of 2009, along with an FDA-required risk evaluation and mitigation strategy.

Ulf Wiinberg, president and chief executive of Lundbeck, stated: “We are pleased to be able to address the unmet medical need patients with infantile spasms have faced and to offer an additional choice in treating refractory complex partial seizures.”

Sabril can be used as a treatment for adults with complex partial seizures, as well as children aged between one month and two years.

Earlier this month, Lundbeck unveiled its second-quarter financial results for 2009, which showed that the company’s revenue reached 3,432 million Danish kroner (396.4 million pounds) during the period.