Featured Article Main Category: Epilepsy Also Included In: Regulatory Affairs / Drug Approvals;Neurology / Neuroscience Article Date: 24 Oct 2012 - 3:00 PDT
Current ratings for: Epilepsy Drug Fycompa Receives FDA Approval
3 (2 votes)
3 (1 votes)
The drug, made by Eisai Inc, the US arm of the Japanese global pharma company, is already approved for use in Iceland, Norway and the European Commission on behalf of its 27 sovereign member states.
Epilepsy is a spectrum of brain disorders, ranging from severe, life-threatening and disabling, to more benign. It arises because of abnormal or excessive activity of nerve cells in the brain, which can cause seizures that give rise to symptoms ranging from strange sensations, unusual behavior, repetitive limb movements (spasms), to generalized convulsions with loss of consciousness.
Partial seizures are the most common type of seizure, affecting some 60% of people with the condition. They affect only a limited or localized part of the brain, but can spread to other parts.
Russell Katz, director of the FDA's Division of Neurology Products in the agency's Center for Drug Evaluation and Research, emphasizes this point in a press statement, adding:
"It is important to have a variety of treatment options available for patients with epilepsy."
Fycompa targets the AMPA glutamate receptor, which is common throughout the central nervous system and helps speed up signals between nerve cells.
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Epilepsy Drug Fycompa Receives FDA Approval