Following the news that AbbVie received a complete response letter (CRL) from the FDA, concerning its new drug application for ABBV-951 (foscarbidopa/foslevodopa) to treat motor fluctuations in patients with advanced Parkinson’s disease;

Christie Wong, Neurology Analyst at GlobalData, a leading data and analytics company, offers her view:

“Although levodopa is a highly effective drug for the treatment of Parkinson’s disease and the gold standard of care for the past 50 years, the emergence of motor fluctuations after a few years of its use, in the form of off-episodes and dyskinesia, remains a major challenge for physicians and patients. AbbVie’s ABBV-951 continuous delivery system of levodopa, holds great potential for controlling motor functions.

“ABBV-951 is intended to replace AbbVie’s own Duodopa (levodopa/carbidopa), an intestinal gel launched in 2015. Key opinion leaders (KOLs) previously interviewed by GlobalData noted that the burden of carrying the pumping apparatus required for Duodopa treatment can often cause severe discomfort for patients. Furthermore, the delivery system was deemed invasive, and requires a surgical procedure to insert a permanent tube through endoscopic gastrostomy and an external portable pump is used to administer levodopa gel.

“In addition to the regulatory snag of a CRL, AbbVie will need to compete with NeuroDerm’s ND-0612 (carbidopa + levodopa). Both companies are racing to the finish line for commercialization of the first subcutaneous infusion of levodopa. Earlier this year, NeuroDerm announced positive results from their pivotal trial evaluating ND-0612 in Parkinson’s Disease patients with motor fluctuations. GlobalData forecasts ND-0612 to launch in the US in Q4 2024.

“KOLs agreed that the novel levodopa delivery systems offered an improved route of administration and will create more options to control various motor complications. While the first-to-market subcutaneous infusion of levodopa will have its own accolades, strong efficacy data, solid marketing, and competitive pricing will be needed to differentiate ABBV-951 and ND-0612, should they receive FDA approval.”