Acorda Therapeutics, Inc. (ACOR - Free Report) announced that the FDA has extended time to review its new drug application (NDA), which seeks an approval for its Parkinson's disease candidate Inbrija. The review period is stretched by three months.
Inbrija (levodopa inhalation powder) is under review for the treatment of OFF periods in patients suffering Parkinson’s and receiving a carbidopa / levodopa regimen.
Previously, the regulatory body was expected to give its decision on Oct 5. However, the FDA delayed its verdict by three months and has now set an action date of Jan 5, 2019.
The FDA postponed the timeline after Acorda submitted additional information regarding chemistry, manufacturing and controls on the regulatory agency’s request. The FDA stated that these submissions deemed a major amendment to the NDA and will require more time to reassess.
This February, the FDA accepted Acorda’s NDA for Inbrija. The company had resubmitted the same for Inbrija in December 2017 after having received a refusal to file letter from the FDA last August related to the NDA, which was first submitted two months back in June. Inbrija is also under review in the EU with a decision expected by 2018-end.
Acorda’s stock declined almost 2.5% on Thursday in response to the above unfavorable news. So far this year, shares of Acorda have lost 15.9%, underperforming the industry’s decline of 4.9%.
Earlier this week, the U.S. Court of Appeals for the Federal Circuit upheld the District Court's previous ruling by a 2-to-1 vote to invalidate four patents of Acorda’s key multiple sclerosis (MS) drug, Ampyra. The result paves the way for a generic product’s entry anytime.
Ampyra is currently approved in the United States for the improvement of walking in multiple sclerosis patients. The drug is available outside the United States under the trade name Fampyra. Acorda has a licensing agreement with Biogen Inc. (BIIB - Free Report) for Fampyra in the ex U.S. markets. The drug generated revenues of $150.3 million during the second quarter of 2018, accounting for almost 98% of the company’s total revenues.
Several companies including Teva Pharmaceutical Industries Ltd. (TEVA - Free Report) and Mylan (MYL - Free Report) developed generic versions of Ampyra. Following the adverse Appeals Court ruling, multiple generic versions of the drug are expected to be launched, which in turn, might hurt the company’s top line significantly.
This stay on the introduction of Inbrija comes as another setback for Acorda. The company projects Inbrija’s market opportunity to be more than $800 million in the United States.
Acorda currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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