Acorda Therapeutics has taken its second hit in less than a week.
The FDA this morning extended its review of Acorda’s (NASDAQ: ACOR) experimental Parkinson’s disease drug Inbrija, an inhalable form of levodopa, by three months. The agency will now decide whether to approve the drug—whose success is critical to the future of the Ardsley, NY, company—by Jan. 5, not Oct. 5.
The FDA recently asked Acorda for more information on “chemistry, manufacturing and controls,” and Acorda’s response constituted “a major amendment and will take additional time to review,” the company said in a statement.
This marks the second time Inbrija’s launch has been delayed. In August 2017, Acorda got a “refuse to file” letter from the FDA, which forced Acorda to resubmit its approval application. Combined, those two delays have allowed a rival drug from Marlborough, MA-based Sunovion Pharmaceuticals to catch up to Inbrija. Sunovion’s drug is a sublingual form of the Parkinson’s drug apomorphine meant for the same group of patients as Inbrija—people suffering “off” episodes, when their medications stop working. It could be approved by Jan. 29.
The announcement comes days after an appeals court rejected Acorda’s attempt to overturn a 2017 ruling invalidating patents for its flagship drug, dalfampridine (Ampyra). Shares have already fallen about 25 percent this week on the court decision. They tumbled another 19 percent in pre-market trading, to $15.00 apiece, on Thursday’s news.
The loss of dalfampridine’s patents has amped up the pressure on Acorda to succeed commercially with Inbrija. Acorda has suffered some setbacks with other experimental drugs over the past few years trying to reshape itself into a Parkinson’s specialist, leaving Inbrija as its lone near-term drug prospect. The company has bullishly predicted that the U.S. market alone for Inbrija could be worth more than $800 million. But as Xconomy wrote earlier this year, Parkinson’s experts have questions about both Inbrija and Sunovion’s APL-130277—which patients will need them, and how both will be integrated into clinical practice.
Here’s more on Acorda, its looming market battle with Sunovion, and Inbrija.