FDA nod at last for Supernus’ Parkinson’s infusion therapy
It is fourth time lucky for Supernus Pharmaceuticals (Nasdaq: SUPN), as its Parkinson’s specialist finally receives US approval for Onapgo (apomorphine hydrochloride).
The company plans to launch the drug-device combination, a continuous infusion treatment for motor fluctuations in Parkinson’s, before the second half of 2025.
The US Food and Drug Administration decision follows three regulatory setbacks for the therapy, previously known as SPN-830, with the agency citing concerns related to product quality, the infusion device, and manufacturing.
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