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

The agency set a new review deadline for Acorda’s levodopa inhaler, for Jan. 5, 2019, after requesting more info on its chemistry, manufacturing and controls. (FDA)

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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That day, Acorda CEO Ron Cohen, M.D., said the company was reviewing its options, including another appeal, and that it was “well-capitalized and fully focused on the potential launch of Inbrija for Parkinson’s disease.” In the second quarter of this year, Ampyra accounted for $150.3 million of Acorda’s $153.3 million in revenue.

RELATED: Under threat of early Ampyra knockoffs, Acorda plans to chop 100 jobs

Come Thursday, Cohen made a new statement: “We look forward to continuing our constructive dialogue with FDA.”

Inbrija had a rough start at the agency, which initially refused to file Acorda’s application in August 2017—due to questions regarding when its Chelsea, Massachusetts, drug manufacturing site would be ready for a preapproval inspection, as well as its master production records. The inhaler itself is being supplied by a contractor.

The FDA accepted Inbrija’s application for review in February. The self-administered therapy is designed to treat the symptoms of “Off” periods on an as-needed basis, for Parkinson’s disease patients taking a carbidopa/levodopa regimen.

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