The U.S. Food and Drug Administration will consider giving marketing approval to Neurocrine Biosciences’ drug for Parkinson’s disease.
On July 10 Neurocrine said the FDA accepted its new drug application for opicapone, a therapy meant to prolong the benefits of existing Parkinson’s treatment levodopa.
“It is our goal to help patients maintain good ON time – the period when their motor symptoms are better controlled – and reduce OFF time – the period when the effects of levodopa have worn off,” said Eiry Roberts, the chief medical officer of Neurocrine, in a news release.
Last year, Neurocrine gained North American rights to opicapone from Portugal’s BIAL for $30 million upfront. In 2016, the drug was approved in Europe, where it’s marketed as ongentys.
Neurocrine CEO Kevin Gorman recently told the San Diego Business Journal that opicapone would be a natural addition to the company’s sales for its movement disorder drug ingrezza.
The company said 38 clinical studies support the drug application. The FDA is expected to make a decision by April 26 of next year.