Bayer Files New Drug Application for Elinzanetant With FDA
By Mauro Orru
Bayer said it has submitted a new drug application with the Food and Drug Administration for elinzanetant, an investigational compound for the treatment of moderate to severe vasomotor symptoms linked with menopause.
The German pharmaceutical and agricultural conglomerate said the decision was based on positive results from the several studies and that it would also submit applications for marketing authorizations to other health authorities.
"The FDA submission for elinzanetant marks a significant milestone in our efforts to offer a new non-hormonal option for women," said Christine Roth, executive vice president for global product strategy and commercialization.
Write to Mauro Orru at mauro.orru@wsj.com
(END) Dow Jones Newswires
August 01, 2024 03:05 ET (07:05 GMT)
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