Acorda Snags Approval for New Treatment of OFF Episodes of Parkinson’s Disease

Acorda Therapeutics can breathe a bit easier. The U.S. Food and Drug Administration (FDA) approved Inbrija, the first inhaled formula of levodopa (L-dopa) for the intermittent treatment of OFF episodes in Parkinson’s disease patients. The approval came about two weeks before its PUDFA date. The regulatory agency was initially expected to make a ruling on Inbrija in October, but the FDA extended the review of the drug to Jan. 5. 2019. In September, Acorda said the delay was due to the FDA’s requests for additional information on chemistry, manufacturing, and controls. The FDA determined the submissions “constitute a major amendment” and will take additional time to review, Acorda said in September.
However, now the FDA has completed its review and given the green-light to Inbrija. The approval is for Parkinson’s patients who are already being treated with carbidopa/levodopa. There are approximately 350,000 people in the U.S. who are challenged by OFF periods related to Parkinson’s disease. In a statement, Acorda Chief Medical Officer Burkhard Blank thanked the FDA for the “constructive dialogue” it had with the company throughout the review cycle for Inbrija. With the approval, Blank said Inbrija can now be “added to patients’ existing Parkinson’s medications for on-demand use, based on individual patient need.”