EMA Accepts MAA Filing of Eisai's Perampanel for the Treatment of Epilepsy
/PRNewswire/ --
Eisai today announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorisation Application (MAA) for perampanel as a treatment for partial-onset seizures in patients with epilepsy. Perampanel is a first-in-class, highly selective non-competitive AMPA-type glutamate receptor antagonist.
Epilepsy is one of the most common neurological conditions in the world and an estimated 6 million people live with epilepsy in . "Uncontrolled seizures have a severe impact on patient quality of life and everyday function, so we look forward to the possibility of being able to offer epilepsy patients a new treatment option in the near future."
The efficacy, safety and tolerability of perampanel has been demonstrated by three Phase III global, randomized, double-blind, placebo-controlled, dose-escalation studies in 1,480 epilepsy patients. The primary and secondary endpoints were the same in all the studies: 50% responder rate, standard median percent seizure reduction, percentage reduction of complex partial plus secondarily generalized seizures, and evaluation for dose response.
Each of the studies showed consistent results in the efficacy and tolerability of perampanel in patients with partial-onset seizures.
Perampanel also has the benefit of once daily dosing, helping to reduce the potential pill-burden a person with epilepsy may experience.
"As a research-based pharmaceutical company with a particular focus on epilepsy, we are committed to bringing innovative new epilepsy therapies to market that offer patients the opportunity for improved seizure control," said , M.D., FAAN, President, Eisai Neuroscience Product Creation Unit. "Perampanel is an exciting new product that has the potential to address the strong unmet need in epilepsy patients and fits entirely within Eisai's human health care mission."
The development of perampanel is a good example of Eisai's human health care corporate mission, the company's commitment to innovative solutions in disease prevention, cure and care for the health and well being of people worldwide. Eisai is committed to the therapeutic area of epilepsy and addressing the unmet medical needs of patients with epilepsy and their families.
Eiasi has also simultaneously submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for perampanel for adjunctive treatment of partial-onset seizures associated with epilepsy.
Partial Complex Seizures - News
The primary and secondary endpoints were the same in all the studies: 50% responder rate, standard median percent seizure reduction, percentage reduction of complex partial plus secondarily generalized seizures, and evaluation for dose response.
The primary and secondary endpoints were the same in all the studies: 50% responder rate, standard median percent seizure reduction, percentage reduction of complex partial plus secondarily generalized seizures, and evaluation for dose response.
But when John was younger, he had weekly complex partial seizures where he would stare into space and drift in and out of consciousness. When he was in eighth grade he had a major brain surgery to help relieve the seizures, and after that, his seizures
If a person has a SIMPLE PARTIAL seizure (the person may experience involuntary twitching of a limb or unusual sensations) and remains conscious, just wait for it to pass. Being understanding and reassuring helps. If a person has a COMPLEX PARTIAL
And while he had not suffered a seizure in the weeks before the fatal crash, he had complained of feeling tired. "During a complex partial seizure a person does not interact normally with other people and is not in control of his or her movements," Ms
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Article about Partial complex seizure. Includes illustrations and topical information provided by ADAM and Drugs.com.
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A complex partial seizure starts focally within the brain and causes impairment of consciousness. ... A complex partial seizure is most commonly a manifestation of temporal lobe ...
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Complex partial seizures sometimes resemble daydreaming or absence seizures : ... Partial Seizures :These seizures usually start in a small area of the ...