EMA Panel Backs Duavive for Menopausal Symptoms

Lara C. Pullen, PhD

Disclosures

October 27, 2014

Conjugated estrogens/bazedoxifene (Duavive, Pfizer) was recommended for approval at the October meeting of the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA).

The 0.45/20 mg modified-release tablets are intended for the treatment of estrogen-deficiency symptoms in postmenopausal women with a uterus for whom treatment with progestin-containing therapy is not appropriate.

The approved indication includes a specific statement: "The experience treating women older than 65 years is limited."

Conjugated estrogens alleviate menopausal symptoms by substituting for the loss of estrogen production in menopausal women. Bazedoxifene is a uterine estrogen receptor agonist and is thus able to reduce the risk for estrogen-induced endometrial hyperplasia.

More than 10% of patients taking Duavive experienced abdominal pain, which was the most common adverse effect. EMA marketing authorization includes required implementation of a pharmacovigilence plan.

Duavive was approved in October 2013 by the United States under the name of Duavee. In the United States, Duavee is indicated for women in menopause who have a uterus to help reduce moderate-to-severe hot flashes and to help reduce the chances of developing osteoporosis.

In the United States, Duavee is marketed with a black box warning. The warning points out that women taking Duavee should not take additional estrogens. The warning also notes that Duavee brings with it an increased risk for endometrial cancer in women with a uterus who use unopposed estrogens.

Also included in the black box warning is a reminder that estrogen therapy should not be used to prevent cardiovascular disease or dementia. In addition, the prescription insert warns that the Women's Health Initiative estrogen-alone study reported an increased risk for stroke as well as an increased risk for deep vein thrombosis.

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