Neurocrine scores FDA nod for Parkinson's drug Ongentys, but won't launch amid pandemic

FDA Building 2
The FDA approved Neurocrine's Ongentys Friday. (FDA)

Neurocrine has been prepping for its Ongentys approval in Parkinson’s disease, and now the FDA has endorsed the drug in combo with existing medicines. But because of the COVID-19 pandemic, Neurocrine won’t be launching until later in 2020. 

The drug is intended to be used in addition to levodopa and carbidopa, current treatments that Neurocrine execs called the “gold standard” for Parkinson’s treatment. Ongentys is designed to extend time between “off” episodes for patients on those drugs, which are periods when symptoms return. 

With the approval, Ongentys becomes Neurocrine’s second drug in movement disorders, following up Ingrezza in tardive dyskinesia. Ongentys was developed in combination with BIAL, a European biotech. 

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The company is “not going to launch into this pandemic,” Neurocrine CEO Kevin Gorman told FiercePharma. Doctors are busy dealing with the outbreak, he said, and some neurology offices are closed. 

“It just makes the most sense to respect that … and when their lives start to look more normal,” it will be the “right time” to launch, Gorman said. 

A Neurocrine spokesman said the company priced the drug "below the specialty tier" of medicines to favor access. Pricing at that tier is $670 per month in Medicare Part D.

Aside from Ongentys and Ingrezza, Neurocrine also developed elagolix in partnership with AbbVie. The endometriosis pain med is approved as Orilissa.