The advisors also recommended that the drug be available under a risk evaluation and mitigation strategy. If approved, Sabril would be the first and only drug approved in the US for the treatment of infantile spasms (IS), said Ovation.
Earlier, the committee unanimously recommended Sabril as an adjunctive treatment for adults with refractory complex partial seizures (CPS) who have inadequately responded to several anti-epileptic drugs and for whom the potential benefits outweigh the potential risks of therapy.
Jeffrey Aronin, Ovation’s president and CEO, said: “We are very pleased with the advisory committee’s unanimous recommendation in support of the safety and efficacy of Sabril for the treatment of adults with refractory CPS and infants with IS. This is a significant milestone for patients and their caregivers who have been waiting so long for an effective and approved treatment option for these catastrophic epilepsies.”