Neurocrine Biosciences Receives FDA Approval for Ongentys, Opts to Delay Launch

FDA Approval

Neurocrine Biosciences announced on Monday that it has received approval from the U.S. Food and Drug Administration (FDA) for its once-daily oral drug, Ongentys, as an add-on treatment to levodopa/carbidopa for the treatment of Parkinson’s disease. Specifically, the approved 25mg and 50mg capsules are aimed at patients with the condition who are experiencing “off” episodes in between treatment doses. However, the launch of Ongentys will be delayed until later in 2020 as a result of the COVID-19 pandemic.

“The FDA approval of Ongentys represents an important new treatment option for people with Parkinson’s disease,” said Robert A. Hauser, M.D., Professor of Neurology and Director, University of South Florida Parkinson’s Disease and Movement Disorders Center. “As Parkinson’s disease progresses, first-line treatments such as levodopa begin to lose effectiveness and the beneficial effects of levodopa begin to wear off more quickly, causing more frequent and often debilitating motor fluctuations in patients. Clinical studies have shown that adding once-daily Ongentys to levodopa therapy significantly reduced ‘off’ time, leading to better and more consistent motor symptom control.”

Ongentys is a selective catechol-O-methyltransferase (COMT) inhibitor that works by blocking the COMT enzyme, which breaks down levodopa, the therapy designed for controlling motor symptoms in patients with Parkinson’s disease. Ongentys protects levodopa by reducing its breakdown in the blood. This ultimately gives it an opportunity to reach the brain, prolonging its clinical effects.

“Due to the progressive nature of Parkinson’s disease, those living with the condition often struggle to control their motor fluctuations, affecting a wide range of functions, including speech, balance and movement, which adversely impact many aspects of life,” said John L. Lehr, President and Chief Executive Officer of the Parkinson’s Foundation. “The Parkinson’s disease community is encouraged by the FDA approval of a new add-on treatment option to help patients further control symptoms, enabling them to better cope with this progressive disease.”

The FDA based its approval of Ongentys on data from 38 clinical studies, including two Phase III clinical studies that included more than 1,000 Parkinson’s disease patients. Safety data from these two studies indicated that the most common adverse reactions associated with Ongentys are dyskinesia, constipation, blood creatine kinase increase, hypotension/syncope, and weight decrease.

Neurocrine Chief Executive Officer Kevin Gorman told Reuters before the announcement of the FDA approval of Ongentys that now is not an “appropriate time” to launch the drug in the neurology community. As a result of the COVID-19 outbreak, hospitals have been forced to cancel unnecessary visits, including those from drug sales personnel. This has resulted in the disruption of launches by pharmaceutical companies.

Gorman added that a month’s supply of Ongentys would have a list price below $670, which is on par with similar drugs on the market. He stated that Neurocrine Biosciences is working with BIAL Portela & Ca SA, its Portugal-based partner, to supply the drug in the future.

On Monday, Nitrome Biosciences also announced that it had raised $38 million in Series A financing to advance its lead program toward clinical trials for Parkinson’s disease, as well as other age-related disorders.

“This financing will enable Nitrome to advance our mission of impacting the lives of patients with neurodegenerative and other age-related diseases,” said Dr. Irene Griswold-Prenner, Ph.D., Founder, CEO and CSO of Nitrome.

Similar to Neurocrine Biosciences, Nitrome Biosciences also targets Parkinson’s disease. The therapies that Nitrome Biosciences develop target enzymes called Nitrases to potentially help or slow the progression of the condition.

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