Acorda Therapeutics Inc. is seeking European Medicines Agency approval to sell its Parkinson's drug Inbrija to patients who are taking carbidopa/levodopa, one of the main drug combinations to treat the disease.
The company filed a marketing authorization application with the regulator, seeking approval for the drug, which is meant to treat patients experiencing so-called off periods — times when the effects of a medication start to wear off in between doses, resulting in the re-emergence of Parkinson's symptoms.
Acorda's submission is supported by the results of a phase 3 trial in which Inbrija significantly improved the motor functions of the patients compared to placebo.
The drug is also under review by the U.S. Food and Drug Administration, which is expected to make a decision Oct. 5.