BioPharma Dive March 28, 2024
Jonathan Gardner

The regulator gave the drug an OK after receiving more safety data from Akebia, but imposed a strict boxed warning for its use.

Dive Brief:

  • The Food and Drug Administration has approved Akebia Therapeutics’ blood-boosting pill Vafseo for people with anemia from chronic kidney disease, the company said Wednesday, reversing a rejection the agency made two years ago over the drug’s safety.
  • The decision came after a review of safety data from Japan, where Vafseo has been used since 2020, in addition to clinical trials Akebia completed before its initial application. Last year, the regulator approved a similarly acting pill called Jesduvroq from GSK with extensive safety restrictions and warnings.
  • Vafseo can only be used in kidney disease patients...

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Topics: Biotechnology, FDA, Govt Agencies, Pharma, Pharma / Biotech
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