Dive Brief:

• The FDA announced approval of the first vaginal ring contraceptive that can be used for a full year of birth control. The Population Council, a global nonprofit research group, developed the product, called Annovera.
• The group said Annovera is the first in a new class of contraceptives. The flexible silicone ring can be inserted and removed by a woman herself. The product is designed to be left in place for 21 days and removed for seven days.
• The contraceptive combines a new progestin, segesterone acetate, with a widely used estrogen, ethinyl estradiol, to inhibit ovulation for an entire year.

Dive Insight:

The data show that Annovera is 97.3% effective in preventing pregnancy when used as directed, according to the Population Council. The product’s risk profile is similar to other combined hormonal contraceptives and includes a boxed warning related to increased cardiovascular risk when used while smoking.

“Having a single contraceptive system that provides a full year of protection while under a woman’s control could be a game-changer for some women,” Population Council President Julia Bunting said in a statement.

The FDA’s approval of Annovera is based in part on data from 17 clinical trials, including two pivotal Phase 3 safety and efficacy trials. The Phase 3 program enrolled a total of 2,308 women across 27 study sites in the United States, Latin America, Europe, and Australia. Women in the trials were between 18 and 40 years of age and were instructed to use the system over 13 menstrual cycles.

The product will be made available in the United States through a license agreement with women’s health company TherapeuticsMD. The company will provide significantly reduced pricing to federally designated Title X family planning clinics serving lower-income women, the Population Council said.

TherapeuticsMD expects Annovera will be commercially launched as early as the fourth quarter of 2019 or first quarter of 2020. Proceeds from the license agreement will be reinvested into the Population Council’s continued research and development programs.

The Population Council said it is continuing efforts to make Annovera available worldwide, including in low- and middle-income countries where more than 214 million women have an unmet need for contraception.

Public and private donors that supported the development of Annovera include the U.S. Agency for International Development, Eunice Kennedy Shriver National Institute of Child Health and Human Development, the Bill & Melinda Gates Foundation, the Avis and Clifford Barrus Medical Foundation and the World Health Organization.