- In a somewhat rare move, the Food and Drug Administration has issued a refuse-to-file letter to Acorda Therapeutics Inc. for its Parkinson’s disease drug Inbrija.
- The regulator determined Acorda's New Drug Application, which was filed on June 26, was "not sufficiently complete to permit a substantive review," the company said in a Tuesday morning statement.
- Shares of Acorda dropped more than 25% in early trading to below $19 per share. The stock had closed at $25.70 on Monday, meaning Tuesday's news erased about half of the stock's resurgence from a 52-week low of $13.60 recorded in late May.
Acorda had filed for approval of Inbrija (levodopa inhalation powder) after notching positive results from a Phase 3 study of the drug this past February. But those plans were set back Tuesday by a red light from the FDA.
The company cited two reasons for getting turned down. According to Acorda, the regulator wants to know the date when the manufacturing site would be ready for inspection and also has questions regarding the submission of the drug master production record.
Jefferies analyst Michael Yee called the issues "reasonably fixable" in a note to clients on Aug. 29. But also pointed out that it is not a good sign the agency seems to be asking several questions.
Acorda has said it will meet with the FDA to discuss the issues and try to remedy the situation as soon as possible in order to refile.
Inbrija is meant to treat the off periods Parkinson's patients can experience when taking a carbidopa/levodopa regimen. These periods are defined as times of day when medication is wearing off and symptoms worsen.
While oral levodopa is a common treatment for the disease, Acorda believes the inhalable version can offer patients a more rapid onset of treatment and more reliable delivery.
The FDA rarely refuses to accept a new drug application, but Acorda is no stranger to the process. The biotech also received a refuse-to-file letter when it first tried to submit its application for its multiple sclerosis walking drug Ampyra (dalfampridine) in 2009. The drug was later approved in 2010.
Acorda is facing other challenges as well. A judge recently struck down several of Ampyra’s patents, opening the door to potential generic competition for the costly drug. Ampyra makes up 95% of Acorda’s current revenues.
The threat to Ampyra and the lack of other revenue streams has spurred an activist investor to recommend the company consider strategic options and a possible sale of the company.
The biotech recently cut its staff by 20% in an effort to save $21 million and refocus resources to Inbrija and another pipeline prospect.