Eisai snags FDA nod for blockbuster hopeful Fycompa

Eisai scored FDA approval for its new epilepsy drug Fycompa. It's the first seizure drug of its kind--a glutamate receptor antagonist--and a blockbuster hopeful for the Japanese drugmaker, which is aiming for top-three status in the seizure drug market.

As PMLive reports, Fycompa's approval follows three late-stage trials that tested it as an add-on treatment for partial-onset seizures, the most common in epilepsy. Seizure rates fell with Fycompa therapy, the studies found; in about a third of patients, rates dropped by 50%, compared with 20% or less of patents in the placebo arm.

FDA said epilepsy patients need to try a variety of drugs for their treatment to be effective. "Some people with epilepsy do not achieve satisfactory seizure control from treatments they are currently using," said Russell Kathz, the Center for Drug Evaluation and Research's neurology chief. "It is important to have a variety of treatment options available."

Fycompa, also known as perampanel, is another option--but it does come with a variety of potential side effects. A boxed warning will flag the risks of mood changes and other mental disturbances, including aggression, anxiety and paranoia. More common side effects include dizziness and weight gain.

Analysts have said Fycompa could hit $500 million in sales by 2015 and eventually break the $1 billion blockbuster barrier. It joins other seizure drugs in Eisai's portfolio, including Zonegran.

- get the FDA statement
- see the PMLive story