Acorda Therapeutics, Inc.ACOR announced that the FDA has accepted its new drug application (NDA) for late stage pipeline candidate, Inbrija. The FDA is expected to give its decision on the candidate on Oct 5, 2018. The company had resubmitted the NDA for Inbrija in December 2017.
Currently, the company is seeking approval for Inbrija in the United States as a treatment option for symptoms of OFF periods in people with Parkinson's using a carbidopa / levodopa regimen.
The NDA was submitted based on data from one phase III safety and efficacy study (SPAN-PD) and from two long-term safety studies (CVT-301-005 and CVT-301-004E) in people with Parkinson's.
We remind investors that in August 2017 the company received a refusal to file ("RTF") letter from the FDA in connection with the NDA that it first submitted in June 2017. However, the FDA declared the application to be incomplete after a preliminary review. As a result, the regulatory body required additional supporting information to review the application.
Notably, the FDA stated two main reasons for the RTF - date specification as to when the manufacturing site can be ready for inspection and questions related to drug master production record. Additionally, the FDA asked for some extra data, unrelated to the central issues of the RTF. Acorda claims that it has addressed these two issues in its resubmission.
Acorda had submitted the NDA as a 505(b)(2) application. The FDA is expected to inform the company within 74 days if the submission is complete and requires a full review.
Apart from Acorda, many companies are trying to introduce treatments for Parkinson's disease in the market namely, Prothena's PRTA PRX002, AstraZeneca's AZN MEDI1341, Prexton Therapeutics' Foliglurax and Prana Biotechnology's PBT434.
Also, Adamas Pharma's ADMS Gocovri received an FDA approval in August 2017 for treating dyskinesia in patients with Parkinson's disease.
Acorda Therapeutics, Inc. Price
Acorda currently carries a Zacks Rank #4 (Sell).
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