Posted by Michael Wonder on 05 Aug 2015
Ligand partner Pfizer receives European marketing authorization for Duavive (conjugated oestrogens/bazedoxifene) for treatment of oestrogen deficiency symptoms in post-menopausal women with a uterus
Ligand Pharmaceuticals Incorporated announced that its partner Pfizer has received EU marketing authorization for DUAVIVE® (conjugated estrogens/bazedoxifene (BZA/CE)) from the European Commission. In the EU, Duavive is indicated for the treatment of estrogen deficiency symptoms in postmenopausal women with a uterus (with at least 12 months since the last menses) for whom treatment with progestin-containing therapy is not appropriate. Ligand will be entitled to a milestone payment following Pfizer obtaining pricing of Duavive in a major European market.
Duavive was studied in a Phase 3 clinical development program (Selective estrogens, Menopause And Response to Therapy [SMART] trials), which included approximately 7,500 postmenopausal women and assessed the safety and efficacy of Duavive for the treatment of estrogen deficiency symptoms, such as moderate-to-severe hot flashes. The most common adverse drug reactions observed in the SMART trials were abdominal pain, vaginal yeast infection and muscle spasms.
