Global Blood Therapeutics Inc. will be poised to launch voxelotor, a new treatment for sickle cell disease, in early 2020 if its US Food and Drug Administration review goes smoothly, setting up a tight race with Novartis AG to bring new treatments to market for sickle cell disease, an area of high unmet medical need with limited treatment options.
GBT's new drug application (NDA) for voxelotor was accepted by the FDA with a priority review and a target action date of 26 February, the company announced on 5 September
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