EMA CHMP adopts positive opinion for Teva's NOMAC-E2 contraceptive pill

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.


The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
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