October 29, 2018 / 10:19 AM / in 22 days

FDA approves TherapeuticsMD's menopause drug

(Reuters) - The U.S. Food and Drug Administration (FDA) approved TherapeuticsMD’s oral hormone therapy for menopause symptoms such as hot flashes, sleep disturbances and night sweats, the company said on Monday.

The regulatory nod is the third in five months for the drugmaker, which received approvals for a birth control device and another hormone therapy for menopause symptoms.

The therapy, Bijuva, is an oral softgel capsule containing a combination of artificial hormones chemically identical to human female sex hormones estradiol and progesterone.

TherapeuticsMD expects Bijuva to be available in the United States in the second quarter of 2019.

About 43 million American women are of the menopausal age of between 45 and 64, according to the U.S. Census Bureau. Some 80 percent of all menopausal women experience symptoms like hot flashes and night sweats, the drugmaker said.

The therapy, considered a potential blockbuster by analysts, is expected to rake in peak U.S. sales of more than $900 million by 2027, with an estimated net price of $100 per prescription, brokerage Cowen & Co said this month.

With nearly 36 million annual prescriptions, the current market size for combination hormone therapies such as Bijuva could be as high as $2 billion, the brokerage said.

Bijuva carries a boxed warning for cardiovascular disorders, breast cancer, endometrial cancer and probable dementia.

Reporting by Manogna Maddipatla in Bengaluru; Editing by Sai Sachin Ravikumar

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