FDA, in Initial Review of NurOwn for ALS, Finds Data Lacking

Joana Carvalhoby Joana Carvalho

In ALS News Today.

FDA, in Initial Review of NurOwn for ALS, Finds Data Lacking

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FDA, in Initial Review of NurOwn for ALS, Finds Data Lacking

Existing safety and effectiveness data from a Phase 3 clinical trial of NurOwn — an investigational cell-based therapy for amyotrophic lateral sclerosis (ALS) — are not sufficient to support the therapy’s approval, the U.S. Food and Drug Administration (FDA) concluded in an initial review. According to the regulatory agency, data submitted by BrainStorm Cell Therapeutics do not yet meet the threshold requirements of clinical evidence for approval of a biologics license application (BLA). Nevertheless, these findings do…

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