Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for NOMAC-E2, an investigational contraceptive pill combining 1.5 mg of 17-beta-estradiol with 2.5 mg of nomegestrol acetate in a 24/4 monophasic regimen.
“We are pleased with CHMP's recommendation to approve NOMAC-E2”
Unlike currently available contraceptive pills, NOMAC-E2 is a monophasic regimen containing an estrogen which is structurally identical to the major estrogen produced by the ovaries of healthy non pregnant women, combined with a selective progesterone analogue (nomegestrol acetate).
"We are pleased with CHMP's recommendation to approve NOMAC-E2", said Gerard van Odijk, President and CEO Teva Europe. "NOMAC-E2, which became part of our innovative pipeline following the acquisition of Théramex, has the potential to expand women's choices in contraception by providing a unique oral contraceptive offering with natural estrogen in a modern regimen. If approved, NOMAC-E2 will provide an important addition to Teva's women's health product portfolio and will advance our efforts to expand our women's health franchise globally".
The CHMP issued its positive opinion following a review of data derived from clinical trials evaluating NOMAC-E2.
If approved for marketing by the European Commission, NOMAC-E2 will be marketed by Teva/Théramex in select European markets.
Teva Pharmaceutical Industries Ltd.