Pluristem Therapeutics Inc to include additional PLX cells data to get FDA's orphan drug application status for rare disease aplastic anemia.
M2 EQUITYBITES-November 22, 2012-Pluristem Therapeutics Inc to include additional PLX cells data to get FDA's orphan drug application status for rare disease aplastic anemia(C)2012 M2 COMMUNICATIONS http://www.m2.com
Cell therapies company Pluristem Therapeutics Inc (TASE:PLTR) said on Wednesday that it has submitted an application to the US Food and Drug Administration (FDA) to designate its PLacental eXpanded (PLX) cells orphan drug status for the treatment of aplastic anemia.
The FDA acknowledged that aplastic anemia is a rare disease with prevalence in the US of less than 200,000.
Additionally, the FDA has requested that the company provides additional information and data for further analysis before the it can determine if the PLX cells can qualify for orphan drug designation for aplastic anemia.
Orphan drug designation reportedly qualifies a company for several benefits under the Orphan Drug Act of 1983 (ODA), as amended, including a seven year period of orphan drug exclusivity upon product approval, a tax credit for certain clinical testing expenses for the orphan drug, written guidance on the non-clinical and clinical studies needed to obtain marketing approval of an orphan drug and orphan drug grants.
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|Date:||Nov 22, 2012|
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