Eisai Co.’s epilepsy drug won U.S. approval to treat patients who suffer seizures as a result of the disease.
The Food and Drug Administration cleared perampanel to treat partial onset seizures, the most common associated with epilepsy, in those older than age 12, the agency said today in a statement. Epilepsy is a general term for conditions involving abnormal electrical activity in the brain. The ailment affects about 2 million Americans, according to the Centers for Disease Control and Prevention.
Eisai, based in Tokyo, is looking for novel medicines to replace dwindling sales of Aricept, its best-selling medicine for Alzheimer’s disease that lost patent protection in 2010. Eisai markets at least two anti-seizure drugs in the U.S. and three in the European Union, according to company’s website.
The drugmaker’s epilepsy franchise will be “substantially enriched” with the approval of perampanel, Haruo Naito, president and chief executive officer of Eisai, said in an earnings call in November. The company expects to become one of the world’s top three firms in the field, Naito said.
Results from three clinical trials show improvement in seizure control in patients taking perampanel, to be known as Fycompa, the agency said in its statement. Among the side effects were dizziness, tiredness, irritability, headaches and falls, according to results from a late-stage clinical trial released in April 2011.
“Some people with epilepsy do not achieve satisfactory seizure control from treatments they are currently using,” said Russell Katz, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “It is important to have a variety of treatment options available for patients with epilepsy.”