Supernus Says FDA Recognized 7 Years Of Orphan Exclusivity For Parkinson's Drug Onapgo
The company also filed for a second Onapgo supplier and still expects potential FDA approval of it by mid-year 2027.
The FDA has recognized seven years of orphan-drug exclusivity for Supernus's Parkinson's drug Onapgo, the company said in an 8-K filed Wednesday. Supernus also said it has submitted an application for a second supplier of the product.
What the 8-K says
The exclusivity covers Onapgo (apomorphine HCl), approved for motor fluctuations in adults with advanced Parkinson's disease. The seven-year period began on February 3, 2025, the date of FDA approval, according to the filing.
The company's press release describes the FDA's orphan drug program as one designed to advance drugs for conditions affecting 200,000 or fewer U.S. patients annually. It calls Onapgo the first and only subcutaneous apomorphine infusion device for that use.
Supernus also filed a supplemental New Drug Application, the paperwork for changing an approved drug's manufacturing details, for a second supplier. It continues to expect potential FDA approval of that supplier by mid-year 2027.
What it changes
The exclusivity period is fixed to the February 3, 2025 approval date, so it is already running. The second-supplier filing follows a supply problem. CEO Jack Khattar, President and Chief Executive Officer of Supernus, said the submission comes in addition to "resolving the supply issue from earlier this year."
Khattar also cited the company's "unwavering focus on ensuring an uninterrupted drug supply for every patient in need." The release lists the ability to get approval to manufacture Onapgo at the second supplier among the risks to its expectations.
SUPN shares closed at $41.21 in Wednesday trading, down 0.05% on the session, before the filing was public at 9:07 p.m. ET.
What to watch
The next marker is the FDA's decision on the second-supplier application, which Supernus expects by mid-year 2027.
The FDA's decision on the second supplier, which Supernus expects by mid-year 2027, is the next event the company has named.
Sources
- 8-K Filing — SUPERNUS PHARMACEUTICALS, INC. (SUPN) — SEC EDGAR
- Exhibit tm2628092d1_ex99-1.htm — SUPERNUS PHARMACEUTICALS, INC. 8-K exhibit — SEC EDGAR
- Supernus Announces Orphan Drug Exclusivity for ONAPGO™ — globenewswire.com
