Global Blood, FDA agree on fast-filing plan for new sickle cell disease drug
A biotech has been given the green light to file for approval of its sickle cell drug — a major win for the company and a sign of new flexibility at…
Updated from 8 am EDT with new clinical trial data.
SAN DIEGO — Global Blood Therapeutics (GBT) said Monday that it had reached an agreement with the Food and Drug Administration for an accelerated approval submission of its experimental drug to treat sickle cell disease.
It is a major win for the South San Francisco-based biotech — and a sign of new flexibility at the FDA, which will allow the company to try to secure faster approval for its drug in a way never used before in sickle cell disease.
The submission plan agreed to by the FDA will encompass data from a showing the drug, voxelotor,
