Research & Development
US FDA's Drugs Advisory Committee to hold review of Bristol-Myers Squibb's and Acceleron's Reblozyl supplemental Biologics License Application
5 December 2019 -

The United States Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee is holding a review of United States-based Bristol-Myers Squibb's and Acceleron Pharmaceuticals supplemental Biologics License Application (sBLA) for the use of Reblozyl (luspatercept-aamt) in patients with myelodysplastic syndromes (MDS) at its meeting on 18 December 2019, it was reported yesterday.

The company is seeking approval of the product, an erythroid maturation agent representing a new class of therapy, intended for the treatment of adult patients with very low- to intermediate-risk MDS -associated anaemia who have ring sideroblasts and require red blood cell transfusions.

Presently, the product is being reviewed by the US FDA for an indication in patients with MDS and it has Prescription Drug User Fee Act or target action, date of 4 April 2020 for completion of the review.

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