Google
Trusted Resources: News & Events
Latest announcements and gatherings
FDA agrees accelerated approval pathway for GBT’s voxelotor
Global Blood Therapeutics, Inc. (GBT) announced that the U.S. Food and Drug Administration (FDA) has informed GBT through discussions and written correspondence that the agency agrees with the Company’s proposal relating to use of an accelerated approval pathway for voxelotor for the treatment of sickle cell disease (SCD). GBT plans to submit an NDA for voxelotor for the treatment of SCD under this pathway. GBT proposed that by raising hemoglobin, voxelotor is reasonably likely to reduce strokes in SCD patients. As part of these discussions, the FDA agreed that transcranial doppler (TCD) flow velocity would be an acceptable primary endpoint in a post-approval confirmatory study to demonstrate stroke risk reduction.
+myBinderRelated Content
-
A Phase 3 Randomized Trial of Voxelotor in Sickle Cell DiseaseBackground: Deoxygenated sickle hemog...
-
Voxelotor in Adolescents and Adults With Sickle Cell Disease: Results of the Phase 3 Hope TrialBackground: Sickle cell disease (SCD) i...
-
GBT Receives FDA Breakthrough Therapy Designation for Voxelotor for Treatment of Sickle Cell Disease (SCD)Global Blood Therapeutics, Inc. (GBT) to...
-
Voxelotor can Promote Long-Term Benefits in Teens, Adults With SCD, Latest Clinical Data ShowGlobal Blood Therapeutics’ lead therap...
-
Global Blood Therapeutics (GBT) announces upcoming data presentations supporting Voxelotor SCD programGlobal Blood Therapeutics, Inc. (GBT) ...
-
GBT announces positive top-line data from part A of the phase 3 HOPE study of Voxelotor in sickle cell diseaseGlobal Blood Therapeutics, Inc. today an...
-
Jazz’ Journey With Sickle Cellhttps://www.youtube.com/watch?v=OMC5wOyD...
To improve your experience on this site, we use cookies. This includes cookies essential for the basic functioning of our website, cookies for analytics purposes, and cookies enabling us to personalize site content. By clicking on 'Accept' or any content on this site, you agree that cookies can be placed. You may adjust your browser's cookie settings to suit your preferences. More Information
The cookie settings on this website are set to "allow cookies" to give you the best browsing experience possible. If you continue to use this website without changing your cookie settings or you click "Accept" below then you are consenting to this.
Powered by
Support for this site is provided by
This platform is made possible through a partnership with the Sickle Cell Disease Association of America, Inc. (SCDAA) and its member organizations. SCDAA's mission is to advocate for people affected by sickle cell conditions and empower community-based organizations to maximize quality of life and raise public consciousness while advancing the search for a universal cure.