Eisai earns FDA nod for Fycompa
pharmafile | June 22, 2015 | News story | Sales and Marketing | Eisai, FDA, Fycompa
The FDA has expanded the patient groups for whom Eisai’s epilepsy drug Fycompa is available to include people who have primary generalised tonic-clonic seizures.
Fycompa (perampanel hydrate) is now available in the US as an adjunctive treatment in patients with epilepsy 12 years of age and older, and comes after the regulator’s review of the Japanese firm’s data from a study in 164 people in this patient group.
In the study, people with primary generalised tonic-clonic (PGTC) seizures treated with Fycompa had a statistically significant reduction in the frequency of their seizures compared with placebo. Some 31% of people in the Fycompa group were free of seizures after 13 weeks, compared with 12.3% in the placebo group.
In May Eisai received the nod from the European regulator, which approved Fycompa as a treatment for idiopathic generalised epilepsy. The green light also means Fycompa can be used to treat seizures in adult and adolescent patients from 12 years of age in Europe.
Fycompa was approved as an adjunctive treatment for partial-onset seizures (with or without secondarily generalized seizures) in patients with epilepsy 12 years of age and older in US in October 2012 and was launched in January last year.
Generalised tonic-clonic seizures can cause significant falls and injury to patients, and are the most important risk factor associated with sudden unexpected death in epilepsy, which affects approximately 2.9 million people in the US. It is estimated that the currently available anti-epilepsy drugs do not control symptoms in 30% of people with epilepsy.
Lilian Anekwe
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