FDA extends review of filing for Acorda's Inbrija in Parkinson's disease

Acorda Therapeutics reported Thursday that the FDA extended its review of a filing seeking clearance of Inbrija (levodopa) by three months to January 5, 2019. The application is for use of the inhaled formulation of levodopa for the treatment of symptoms of OFF periods in people with Parkinson's disease taking a carbidopa/levodopa regimen. Shares in the drugmaker were down as much as 19 percent on the news. 

Acorda noted that the delay follows recent submissions made in response to requests from the FDA for additional information on chemistry, manufacturing and controls. "We look forward to continuing our constructive dialogue with FDA," commented CEO Ron Cohen.  

The news comes after the FDA issued a refusal-to-file letter to Acorda for its filing seeking approval of Inbrija last year. The agency accepted Acorda's resubmission for the treatment in February.  

The news additionally follows a US appeals court ruling disclosed earlier this week, upholding a lower court decision that invalidated four patents covering Acorda's multiple sclerosis treatment Ampyra (dalfampridine). In August, the company separately reached an agreement with Mylan to delay the launch of the latter's generic version of the drug until 2025.  

Meanwhile, sources disclosed earlier this year that Acorda could put itself up for sale.

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