Sunovion drug receives FDA approval
Marlborough-based Sunovion Pharmaceuticals has received federal approval for its drug Aptiom as a monotherapy for the treatment of partial-onset epileptic seizures, the company announced.
The drug was first approved in 2013, but a recent decision by the Food and Drug Administration (FDA) to approve the company’s supplemental new drug application makes Aptiom the first once-daily non-extended release antiepileptic drug (AED). The drug can be used alone or in conjunction with other AEDs.
The new approval gives health care providers greater flexibility, said Dr. Antony Loebel, executive vice president and chief medical officer at Sunovion.
In the U.S. more than one million people have uncontrolled seizures, representing about one-third of all people with epilepsy, according to the company. In New England, there are approximately 140,000 with epilepsy.
“Sunovion has an ongoing commitment to people living with epilepsy. This approval reinforces our track record of bringing CNS therapies to market,” said David Frawley, Sunovion’s senior vice president and chief commercial officer.
The approval is seen as a milestone for Sunovion, which also produces the drugs Lunesta and Latuda and has remained committed to research and development of drugs to treat disorders of the brain and spinal cord.
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