PFE · 10-Q · 2026Q2 · Full report

Oxbryta Regulatory Withdrawal

PFIZER INC · 2026-08-04 · Importance 47 · Surprise 60

After the FDA determined there was no viable pathway to return Oxbryta to the U.S. market, Pfizer voluntarily withdrew the product’s U.S. New Drug Applications on July 31, 2026. The EMA had previously concluded its referral procedure in October 2025 with a negative benefit-risk opinion and recommended that Oxbryta’s EU marketing authorization remain suspended. Pfizer had withdrawn all lots globally in September 2024 and discontinued active voxelotor trials and expanded-access programs.

Key facts

• Pfizer voluntarily withdrew the NDAs for Oxbryta on July 31, 2026 after engagement with the FDA determined there was no viable pathway to return Oxbryta to the U.S. market. source
• In September 2024 Pfizer announced voluntary withdrawal of all lots of Oxbryta for SCD in all markets and discontinued all active voxelotor clinical trials and expanded access programs worldwide. source