FDA sets back review date of Acorda’s levodopa inhaler for Parkinson’s disease

Acorda Therapeutics’ share price took a beating this week, losing about a third of its value after a one-two punch from the courts and the FDA, which extended its review of its drug-device combination treatment for Parkinson’s disease by three months.

The agency pushed back the PDUFA date of Acorda’s inhaled levodopa therapy Inbrija from Oct. 5 to Jan. 5, 2019. In a statement, the company said the FDA requested additional information on chemistry, manufacturing and controls, and the major amendment to its application will take additional time to review.

And the Monday before, a federal appeals court upheld a ruling invalidating four patents for Acorda’s main moneymaking drug, multiple sclerosis muscle-strengthener Ampyra, with generics on the way.

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