Before garnering approval on Tuesday, Onapgo had been rejected twice by the FDA.
The FDA on Tuesday signed off on Supernus Pharmaceuticals’ apomorphine hydrochloride injection—to be marketed under the brand name Onapgo—for use in adults with Parkinson’s disease.
According to Jefferies analysts, this approval gives Supernus access to a U.S. market opportunity worth between $100 million and $300 million. The company expects to launch Onapgo in the second quarter of this year, and while there has been no announcement yet of its price, Jefferies expects it to be broadly in line with AbbVie’s Vyalev, a similar drug-device product for Parkinson’s that has an annual wholesale acquisition cost of approximately $119,000.
“To us, Vyalev and Onapgo seem fairly comparable in terms of efficacy,” the Jefferies analysts wrote, though they pointed to several distinguishing factors for Supernus, including a “potentially better tolerability profile” and different mechanism of action. Doctors “may want to switch MOAs as patients progress further in their disease,” the analysts contended.
Onapgo is a drug-device combination that allows for the continuous subcutaneous infusion of apomorphine and is indicated for the treatment of motor fluctuations in Parkinson’s disease patients. Onapgo’s label is relatively clean, with safety precautions for patients taking certain nausea medications—including ondansetron and granisetron—and for those who are allergic to any of the infusion’s ingredients.
The FDA’s approval on Tuesday was backed by data from a Phase III trial, which enrolled 107 patients and showed that Onapgo led to a significant drop in daily off time and elicited a significant increase in daily good on time. These treatment benefits became apparent as early as one week after treatment initiation and were sustained through the duration of the study.
In a statement, Supernus CEO Jack Khattar said that Onapgo’s approval gives prescribers “a novel approach for adults with Parkinson’s disease who are experiencing motor fluctuations.”
Tuesday’s approval is the culmination of what has been a difficult regulatory road for Onapgo. In October 2022, the FDA rejected Supernus’ drug application, citing the need for additional information regarding the infusion device, as well as more analysis of the drug product. The regulator at the time identified several areas of deficiencies, including labelling, product quality, risk analysis and manufacturing.
Two years later, in April 2024, the FDA again hit Supernus with a Complete Response Letter, pointing to two specific areas where it needed additional information: product quality and the infusion device. At the time, Supernus emphasized that the regulator had not flagged issues with the drug’s clinical safety or efficacy.
