Acorda Therapeutics' Inbrija gets approval
Acorda Therapeutics has received the Food and Drug Administration’s green light for Inbrija for intermittent treatment of OFF episodes in people with Parkinson’s disease treated with carbidopa/levodopa.
OFF episodes, or OFF periods, are defined as the return of Parkinson’s symptoms that result from low levels of dopamine between doses of oral carbidopa/levodopa, the standard oral baseline Parkinson’s treatment.
“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,” Acorda president and CEO Ron Cohen said. “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.”
Inbrija, which is expected to be available in the first quarter of 2019, will be distributed through a network of specialty pharmacies.
“Despite being on treatment, patients may experience OFF periods as Parkinson’s progresses, which can be disruptive,” The Michael J. Fox Foundation's CEO, Todd Sherer, 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.”
OFF episodes, or OFF periods, are defined as the return of Parkinson’s symptoms that result from low levels of dopamine between doses of oral carbidopa/levodopa, the standard oral baseline Parkinson’s treatment.
“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,” Acorda president and CEO Ron Cohen said. “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.”
Inbrija, which is expected to be available in the first quarter of 2019, will be distributed through a network of specialty pharmacies.
“Despite being on treatment, patients may experience OFF periods as Parkinson’s progresses, which can be disruptive,” The Michael J. Fox Foundation's CEO, Todd Sherer, 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.”