martes, 4 de diciembre de 2018

Global Blood, FDA agree on fast-filing plan for new sickle cell disease drug

Global Blood, FDA agree on fast-filing plan for new sickle cell disease drug

The Readout

Damian Garde



Global Blood’s gambit just might work


For months, Global Blood Therapeutics has been confident that its treatment for sickle cell disease can win FDA approval based on secondary measures of its efficacy. That confidence engendered more than a little skepticism (among STAT employees, even), but yesterday the company won out.

According to the company, the FDA has promised to consider Global Blood’s drug based on how well it boosts patients’ hemoglobin rather than holding out for actual outcomes data.

That’s good news for Global Blood, whose share price rose nearly 50 percent, but it hardly amounts to a guarantee. If the FDA isn’t satisfied with those hemoglobin data — or if it finds any other deficiency — it could still up and reject Global Blood’s drug.

Read more.

Global Blood, FDA agree on fast-filing plan for new sickle cell disease drug

No hay comentarios: