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 approval represents a long-awaited win for Ardsley, N.Y.-based Acorda – the FDA refused to review the company’s Inbrija application in 2016. Acorda resubmitted the application in February this year.
“Today’s approval of Inbrija marks a major milestone for both Acorda and the Parkinson’s community, for whom we are gratified to have developed this much needed therapy,” president & CEO Dr. Ron Cohen said in prepared remarks.
“This milestone resulted from over two decades of research and development, beginning in the laboratory of Dr. Robert Langer at Massachusetts Institute of Technology, through years of enormous perseverance and ingenuity by the entire Acorda team,” Cohen added.
“Despite being on treatment, patients may experience OFF periods as Parkinson’s progresses, which can be disruptive,” Todd Sherer, CEO of The Michael J. Fox Foundation, said. “The Foundation provided funding for the early clinical development of Inbrija because patients told us that off periods were one of their most serious issues. We knew we had to help address this unmet need, and this approval is a significant step forward for the community as it provides a new option to manage these gaps in symptom control.”
“I’m delighted that Inbrija has been approved and may be added to patients’ existing Parkinson’s medications for on-demand use, based on individual patient need,” Dr. Burkhard Blank, Acorda’s CMO, said.
“We thank the FDA for a constructive dialogue throughout the development program and their partnership during the review cycle. We especially thank all those who volunteered for the Inbrija clinical trials, without whose commitment new medications could not be developed. And we are grateful for the people living with Parkinson’s, their care partners, researchers, clinicians and advocacy groups, who have all collaborated with us to help achieve this milestone,” Blank said.