Hutchmed, Takeda's Fruquintinib Accepted for Regulatory Review by EMA
June 15 2023 - 10:30AM
Dow Jones News
By Michael Susin
Hutchmed (China) and Takeda Pharmaceutical said Thursday that
the European Medicines Agency has accepted the marketing
authorization application for fruquintinib, a treatment for
previously-treated metastatic colorectal cancer, for regulatory
review.
The companies said that if approved, fruquintinib will be the
first treatment of its type in the European Union.
"We are thrilled to have submitted the marketing authorization
application to the EMA, bringing us one step closer to potentially
offering this innovative therapy to patients with advanced
disease," Takeda's head of Global Medical Affairs Oncology Awny
Farajallah said.
The application includes positive data from a last stage
clinical trial, which demonstrated superiority of the therapy when
compared with a placebo, it added.
Write to Michael Susin at michael.susin@wsj.comto Michael Susin
at michael.susin@wsj.com
(END) Dow Jones Newswires
June 15, 2023 11:15 ET (15:15 GMT)
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