Takeda to Voluntarily Withdraw Exkivity Following Talks with FDA
03 October 2023 - 8:16AM
Dow Jones News
By Denny Jacob
Takeda Pharmaceutical plans to voluntarily withdraw exkivity
following discussions with the Food and Drug Administration.
The company, which develops and manufactures pharmaceutical
drugs, said it intends to similarly initiate voluntary withdrawals
where the treatment is approved and is working with regulators in
other countries where it is available on next steps.
The decision to withdraw was based on the outcome of a Phase 3
trial that didn't meet its primary endpoint, didn't fulfill
confirmatory data requirements of the accelerated approval granted
by the FDA or the conditional marketing approvals granted in other
countries, Takeda said.
The withdrawal of exkivity in the U.S. is for adult patients
with epidermal growth factor receptor Exon20 insertion
mutation-positive locally advanced or metastatic non-small cell
lung cancer whose disease has progressed on or after platinum-based
chemotherapy.
Takeda said it will continue to assess the impact of its
withdrawal and will update its outlook for the fiscal year ending
March 31 if necessary.
Write to Denny Jacob at denny.jacob@wsj.com
(END) Dow Jones Newswires
October 02, 2023 17:01 ET (21:01 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.
Takeda Pharmaceutical (NYSE:TAK)
Historical Stock Chart
From Apr 2024 to May 2024
Takeda Pharmaceutical (NYSE:TAK)
Historical Stock Chart
From May 2023 to May 2024