Theramex announced today that it received decentralized procedure approval in several EU countries and the UK for its Bijuva capsules.
Bijuva possesses an indication for continuous combined hormone replacement therapy (HRT) for estrogen deficiency symptoms in postmenopausal women with intact uterus and with at least 12 months since last menses, according to a news release.
London-based Theramex, formerly the women’s health business arm of Teva Pharmaceuticals, said Bijuva is the first and only oral combined HRT with bio-identical hormones to be made available to patients across Europe. It is being made available through a license agreement signed with TherapeuticsMD in 2019 that granted Theramex the exclusive license and supply rights for Bijuva outside the U.S., Canada and Israel.
“Up to 80% of women experience vasomotor symptoms during their menopause transition, and these lasted more than 7 years for more than half of the women,” Theramex CEO Robert Stewart said in the release. “With Bijuva, Theramex aims to help these patients with an oral combination of low dose estradiol and progesterone which have the same chemical and molecular structure as the hormones produced naturally in a woman’s body.”
Decentralized procedure approval can be used for medicines that do not need to be authorized by the centralized procedure and have not already been authorized in any member state of the EU.