Eisai will be celebrating news that US regulators have at last given the all clear to its novel epilepsy drug Fycompa.
The US Food and Drug Administration has approved the use of Fycompa (perampanel) as an adjunctive treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy age 12 and above.
The news must come as somewhat of a relief to the firm, given that in July last year US regulators turned down the drug, requesting a reanalysis of data.
Fycompa is the first in an entirely new class of therapies for uncontrolled partial epilepsy, the most common form of the condition.
The drug is the only licensed anti-epileptic drug (AED) to selectively target AMPA receptors, which play a crucial role in the spread of epileptic seizures.
This gives Fycompa a different mechanism of action to rival AEDs on the market, and the drug has an added advantage of having a once-daily dosing regimen, which may give it a competitive edge.
Reducing seizure frequency
Approval was based on clinical data from three pivotal Phase III studies involving 1,480 patients with partial-onset seizures, which found that Fycompa, when used as an adjunctive therapy, significantly cut seizure frequency in the target patient group, Eisai said.
There are an estimated 2.2 million people living with epilepsy in the US. But of the 60% suffering partial-onset epilepsy, 25% to 30% are still experiencing seizures despite therapy, highlighting the scope for improvement in outcomes.
The FDA has recommended that Fycompa be classified by the Drug Enforcement Administration as a scheduled drug under the country’s Controlled Substances Act, and it also comes with a boxed warning describing the potential for serious side effects including new or worse aggressive behaviour (including homicidal behaviour) and other extreme mood changes.
Fycompa won approval in Europe in July this year.