Bristol-Myers: myeloma drug gets fast FDA review

(CercleFinance.com) - Bristol-Myers Squibb's treatment for multiple myeloma may reach the US market more quickly, the drugmaker said on Thursday.


The US Food and Drug Administration (FDA) accepted its supplemental biologics license application for Empliciti for the treatment of patients with relapsed/refractory multiple myeloma (RRMM), for whom at least two prior therapies have failed, it said.

The FDA usually takes months to review a potential drug, but will give Empliciti a quicker review after positive Phase 2 study, the company said.

The FDA is expected to announce a decision regarding its approval by 27 December, Bristol said.



Copyright (c) 2018 CercleFinance.com. All rights reserved.