Shionogi Wins U.S. Backing for Menopause Vaginal-Atrophy Therapy

Feb. 26 (Bloomberg) -- Shionogi & Co., the Japanese maker of the Crestor cholesterol pill, won U.S. approval of its treatment for vulvar and vaginal atrophy in menopausal women.

The Food and Drug Administration cleared the drug, ospemifene, which is intended to help women who are experiencing painful sex because of vaginal atrophy associated with menopause, the agency said today in a statement. The pill would be the first oral treatment for the condition, which is currently treated with lubricants or estrogen-based suppositories.

No product is marketed specifically for this use and ospemifene, to be known as Osphena, may generate $495 million in sales in 2017, Naomi Kumagai, an analyst with Jefferies & Co. in Tokyo, said in an e-mail before the announcement. More than 7.1 million women are diagnosed annually with vulvar and vaginal atrophy, when the tissues of the vaginal lining grow thin and lose elasticity, Osaka, Japan-based Shionogi said in a statement.

--Editors: Romaine Bostick, Andrew Pollack