Leading placenta-based cell therapies developer Pluristem Therapeutics announced it is submitting its application to the FDA to request Orphan Drug Designation for its PLacental eXpanded (PLX-PAD) cells for treating severe preeclampsia.
Receiving Orphan Drug Designation can qualify a company for various benefits under the Orphan Drug Act of 1983 (ODA), as amended, including a seven-year period of orphan drug exclusivity upon approval of the product, a tax credit for certain clinical testing expenses for the orphan drug, written guidance on the nonclinical and clinical studies necessary for obtaining market approval of an orphan drug, and orphan drug grants.
Pluristem recently established a preeclampsia steering committee featuring key medical opinion leaders, and this Orphan Drug application submission is an important step for the company in advancing its preeclampsia development program. The great unmet medical need for preeclampsia makes this indication one of the company's top priorities. Pluristem looks forward to advancing into human trials and is hopeful that strong preclinical data for PLX cells will lead to similar findings at the clinical level.
Orphan Drug Designation has been successfully received by Pluristem for PLX cells in two other indications: treatment of aplastic anemia and treatment of Buerger's disease.
For more information about Pluristem, visit pluristem.com
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