Myovant, Pfizer: FDA to Review Myfembree for Endometriosis Pain
09 Setembro 2021 - 9:06AM
Dow Jones News
By Colin Kellaher
Myovant Sciences Ltd. and Pfizer Inc. on Thursday said the U.S.
Food and Drug Administration accepted their application for
expanded approval of Myfembree for the management of moderate to
severe pain associated with endometriosis.
The companies said the agency, which in May approved Myfembree
for the management of heavy menstrual bleeding associated with
uterine fibroids in premenopausal women, set a target action date
of May 6 for the new indication.
Myovant and Pfizer, which are jointly developing and
commercializing Myfembree in the U.S., said approval would provide
a one-pill, once-daily treatment option for endometriosis, an
inflammatory disease in which tissue similar to the uterine lining
grows outside the uterine cavity.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
September 09, 2021 07:51 ET (11:51 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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