Pluristem's PLX-PAD cells for severe preeclampsia gain FDA Orphan status

The US Food and Drug Administration has granted Israel-based cell therapy products developer Pluristem Therapeutics’ (TASE: PSTI) PLX-PAD cells Orphan Drug designation in the treatment of severe preeclampsia, with the news pushing the company’s shares up 18.4% to 466.00 Israeli shekels.

Preeclampsia is among the most common medical complications of pregnancy and a leading cause of premature births, stillbirths and neonatal and maternal deaths. There is no cure except delivery. Due to high risks to the mother, women diagnosed with severe preeclampsia are usually delivered promptly, even if the baby will be born prematurely and may suffer permanent disabilities as a result. Severe preeclampsia occurs in around 1% of pregnancies in Western countries.

Benefits of Orphan Drug designation for PLX-PAD cells include close guidance that may accelerate time to marketing approval, orphan drug grants, tax credits, and a seven-year market exclusivity upon marketing approval. It is estimated by different sources that preeclampsia costs the global health care system about $3 billion annually.