Kynmobi gets FDA nod for Parkinson's disease OFF episodes
In a U-turn by the US regulator, the Food and Drug Administration on Thursday approved Kynmobi (apomorphine HCI) sublingual film (APL-130277) for the acute, intermittent treatment of OFF episodes in patients with Parkinson’s disease (PD).
The sublingual film formulation was developed by Sunovion, a wholly-owned subsidiary of Japan’s Sumitomo Dainippon Pharm (TYO: 4506), expects Kynmobi to be available in US pharmacies in September 2020. It is the first and only sublingual therapy approved for the on-demand treatment of PD OFF episodes, according to the company.
In January 2019, the FDA issued a complete response letter (CRL) on apomorphine, requesting additional information and analyses, but no new clinical studies. Sunovion re-filed for approval in November last year.
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