Eisai Co.’s epilepsy drug has won the approval of the Food and Drug Administration to treat patients who suffer from seizures because of the disease.
The FDA cleared the drug, perampanel, to treat partial onset seizures, which are the most common associated with epilepsy, reports Bloomberg BusinessWeek.
The drug is used to treat those who are over the age of 12, according to a FDA statement on Monday.
Epilepsy is a general term that is used to describe a condition that involves abnormal electrical activity in the brain. The disease affects about two million Americans, according to a report by the Centers for Disease Control.
Eisai is based in Tokyo and is looking for novel medicines that replace dwindling sales of Aricept. Aricept is the pharmaceutical company’s Alzheimer’s disease, which lost its patent protection in 2010.
Eisai currently markets at least two anti-seizure medications in the US, as well as three in the European Union. Haruo Naito, president and CEO of the company, stated that their epilepsy franchise will be “substantially enriched” with the addition of perampanel in the US.
Naito added that the company expects to become one of the world’s top three firms in the field of epilepsy drugs. The Chicago Tribune notes that Russell Katz, an official at the US Food and Drug Administration’s Center for Drug Evaluation and Research, stated:
“It is important to have a variety of treatment options available for patients with epilepsy.”
The FDA added that the drug was approved based on Fycompa outperforming a placebo in three separate clinical studies. Fycompa’s side effects include dizziness, weight increase, blurred vision, and excessive sleep.
The drug’s packaging will include a warning for prescribers and patients about the risks of medication, including aggression, anger, anxiety, paranoia, and agitation. The epilepsy drug’s users will also include a patient medication guide, which includes instructions on both the drug’s use and safety information.