IPM’s Dapivirine Ring Receives WHO Prequalification
On November 30, 2020, the nonprofit International Partnership for Microbicides (IPM) announced that the World Health Organization’s (WHO) has issued a prequalification of the dapivirine ring, a monthly vaginal ring to reduce women’s HIV risk.
As we reported earlier [A&U, August 2020], in July 2020 The European Medicines Agency (EMA) rendered a “positive opinion” regarding use of the dapivirine vaginal ring by cisgender women ages eighteen and older in developing countries. WHO’s prequalification confirms that the ring meets global standards for quality, safety and efficacy. The ring’s addition to the WHO’s list of prequalified medicines will guide national and global procurement decisions, pending country regulatory approvals for its use. IPM will seek initial approvals in eastern and southern Africa where the need is most urgent. IPM plans to submit the dapivirine ring to regulatory agencies later this year through a collaborative procedure led by the WHO that accelerates country regulatory reviews for products given a positive opinion from the EMA or other regulatory authority. IPM also plans to apply to the US Food and Drug Administration in 2020 for approval.
Dr. Zeda F. Rosenberg, founder and chief executive officer of IPM, said in a press release, “WHO prequalification brings the dapivirine ring an important step closer to being made available to women, who want and deserve new choices in HIV prevention. Our aim is to make the ring available first in sub-Saharan Africa, where women face persistently high HIV risk.”
Women bear a disproportionate burden of the global HIV/AIDS epidemic, making up nearly 60% of new adult infections in sub-Saharan. The monthly dapivirine ring could provide a long-acting product that a woman controls and can use discreetly to reduce her HIV risk during vaginal sex. Expanding women’s options to choose the method that best meets their individual needs—whether systemic or non-systemic, long-acting, daily or on-demand—is essential to controlling the HIV/AIDS epidemic.
IPM is a nonprofit organization that develops new HIV prevention tools and other sexual and reproductive health technologies for women and makes them available in developing countries. IPM has offices in the United States, South Africa and Belgium.
For more information, visit: www.IPMglobal.org.
—Reporting by Hank Trout
Hank Trout, Senior Editor, edited Drummer, Malebox, and Folsom magazines in the early 1980s. A long-term survivor of HIV/AIDS (diagnosed in 1989), he is a forty-year resident of San Francisco, where he lives with his husband Rick Greathouse. Follow him on Twitter @HankTroutWriter.