Takeda Says Will Be Working With FDA Towards Voluntary Withdrawal Of EXKIVITY (Mobocertinib) In US; Says Phase 3 EXCLAIM-2 Confirmatory Trial Did Not Meet Its Primary Endpoint
Takeda intends to similarly initiate voluntary withdrawal globally where EXKIVITY is approved and is working with regulators in other countries where it is currently available on next steps.Takeda will continue to assess the impact of the withdrawal and update our full-year, consolidated forecast for the fiscal year ending March 31, 2024 (Fiscal Year 2023), as appropriate and necessary.