Acorda Therapeutics
(NSDQ:ACOR) said today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of its Inbrija device for the intermittent treatment of “off” episodes in people with Parkinson’s disease.
The self-administered, inhaled therapy is designed for people experiencing a re-emergence of Parkinson’s symptoms. These “off” episodes are caused by low levels of dopamine between doses of the standard oral Parkinson’s therapy, carbidopa/levodopa, according to Acorda. The FDA approved Inbrija in December 2018.
The CHMP decision is based on a clinical trial for INBRIJA that included approximately 900 people with Parkinson’s on a levodopa/dopa-decarboxylase inhibitor regimen experiencing OFF periods. Results of the Phase 3 pivotal efficacy trial were published in The Lancet Neurology in February.
The Ardsley, N.Y.-based company said it expects a decision from the European Commission in the coming months.
“We are delighted that Inbrija has achieved this important milestone, and look forward to the E.C.’s final decision later this year,” said Acorda president & CEO Dr. Ron Cohen in a news release. “There are approximately 1.2 million people in the E.U. living with Parkinson’s. We estimate that 40% of these individuals experience ‘off’ periods, which are considered extremely disruptive. Acorda is currently evaluating partnering opportunities to commercialize Inbrija in Europe.”
