Committee For Medicinal Products For Human Use (CHMP) Issues Positive Opinion For New Contraception Offering, NOMAC-E2

Main Category: Women's Health / Gynecology
Also Included In: Regulatory Affairs / Drug Approvals
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Teva Pharmaceuticals Europe BV, a wholly-owned subsidiary of Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) and MSD (known as Merck in the United States and Canada) (NYSE:MRK) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for NOMAC-E2 (nomegestrol acetate 2.5 mg /17ß-estradiol 1.5 mg) an investigational monophasic combined oral contraceptive (COC) tablet indicated for the use by women to prevent pregnancy. NOMAC-E2 is a birth control pill that contains 2 steroid hormones nomegestrol acetate, a highly selective, progesterone-derived progestin and 17-beta estradiol (E2), an estrogen that is similar to the one naturally present in a woman's body. The next step for marketing authorization is review by the European Commission.

"If approved, NOMAC-E2 has the potential to expand women's choices in contraception by providing another oral contraceptive offering and is the result of a fruitful collaboration with MSD."

"We are pleased with CHMP's recommendation to approve NOMAC-E2", said Christophe Hubert, managing director of Théramex and vice-president Women's Health Teva Europe. "If approved, NOMAC-E2 has the potential to expand women's choices in contraception by providing another oral contraceptive offering and is the result of a fruitful collaboration with MSD."

"The achievement of this milestone highlights the strong collaborative relationship we have established with our colleagues at Théramex, now part of Teva," said Terrie Curran, general manager and global franchise head, Women's Health at MSD. "This underscores our ongoing commitment to developing therapies that help improve the health of women worldwide."

The CHMP issued a positive opinion following a review of comprehensive data supporting the efficacy, safety and tolerability profile of NOMAC-E2 (nomegestrol acetate/17ß-estradiol). Should marketing authorization from the European Commission be granted, it will apply to all 27 European Union (EU) Member States plus the EEA-EFTA states (Iceland, Liechtenstein and Norway).

Source:
Teva Pharmaceutical Industries Ltd.
MSD

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