The FDA has approved Acorda’s Inbrija levodopa DPI for the treatment of OFF episodes in Parkinson’s disease patients taking carbidopa/levodopa, the company said. Inbrija is expected to be available to patients in the US in the first quarter of 2019.
Acorda initially submitted a 505(b)(2) NDA for Inbrija in June 2017, and the FDA issued a refuse to file letter in response, stating that the information included in the submission was insufficient. Acorda refiled the application in December 2017; the FDA then accepted the NDA and assigned a PDUFA date of October 5, 2018. In September 2018, the FDA extended the PDUFA date to January 5, 2019.
Inbrija is based on Acorda’s ARCUS dry powder inhalation platform, which it acquired with the acquisition of Alkermes spin off Civitas Therapeutics in 2014. The ARCUS technology was originally developed at MIT and later at Advanced Inhalation Research, which was acquired by Alkermes in 1999.
Acorda President and CEO Ron Cohen said, “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. 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.”
Chief Medical Officer Burkhard Blank added, “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. 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.”
Todd Sherer, CEO of the Michael J. Fox Foundation commented, “Despite being on treatment, patients may experience OFF periods as Parkinson’s progresses, which can be disruptive. 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.”
Read the Acorda Therapeutics press release.
