🇺🇸 Besponsa in United States

FDA authorised Besponsa on 6 March 2024

Marketing authorisation

FDA — authorised 6 March 2024

  • Application: BLA761040
  • Marketing authorisation holder: WYETH PHARMS INC
  • Indication: Efficacy
  • Status: approved

The FDA approved Besponsa, a treatment for adult patients with relapsed or refractory acute myeloid leukemia (AML). The approval was granted to WYETH PHARMS INC, the marketing authorisation holder. This approval was based on the drug's efficacy in treating AML, as demonstrated in clinical trials.

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Pricing & reimbursement

Besponsa in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Oncology approved in United States

Frequently asked questions

Is Besponsa approved in United States?

Yes. FDA authorised it on 6 March 2024.

Who is the marketing authorisation holder for Besponsa in United States?

WYETH PHARMS INC holds the US marketing authorisation.

What does Besponsa cost in United States?

annual_list: USD 398000.00 per year. Final patient cost depends on reimbursement and any patient access scheme.