July 24, 2020
Dear MTN Friends and Family,
Good news travels fast, so we wanted to be sure that you were among the first to know that the European Medicines Agency (EMA) has adopted a positive opinion for the dapivirine vaginal ring! A positive opinion moves the ring much closer to its approval in African countries where cisgender women’s HIV prevention needs are among the greatest. It’s been a long road for our colleagues at the International Partnership for Microbicides (IPM), but we are grateful to them for developing the roadmap for the dapivirine ring and inviting the MTN to take part in this journey. We give our heartfelt congratulations to IPM – most especially, Zeda Rosenberg – for achieving this incredibly important milestone. And, a round of applause for each and every one of you for the critical role you played.
Data from eight MTN studies were included in the EMA’s review: ASPIRE (MTN-020) and HOPE (MTN-025), but also studies in adolescents (MTN-023/IPM 030), which was conducted in collaboration with the Adolescent Medicine Trials Network for HIV/AIDS Interventions, post-menopausal women (MTN-024/IPM 031), and lactating women (MTN-029/IPM 039). Safety in men was studied in MTN-012/IPM 010. Pharmacokinetic data was provided by MTN-013/IPM 026, while MTN-015 was an observational study of women who acquired HIV during participation in ASPIRE and HOPE. We thank the chairs and co-chairs of these studies (Thesla Palanee-Phillips, Nyaradzo Mgodi, Kathleen Squires, Katherine Bunge, Beatrice Chen, Lori Panther, Richard Beigi, Lisa Noguchi, Ross Cranston and Sharon Riddler), which involved a total of 22 research sites in Malawi, Uganda, the U.S., South Africa and Zimbabwe. Indeed, we are indebted to the study teams and the nearly 3,000 participants who gave generously of their time and of themselves. We would especially like to thank our ASPIRE sites, who conducted this study according to the highest standards and with an unwavering commitment to excellence.
While this is cause for celebration, there’s still much to do. IPM will be diligently seeking approvals from African regulators, as well as the FDA, and planning for the ring’s potential introduction. For our part, we will be focused on completing studies of the ring’s safety in adolescent girls and young women (REACH/MTN-034) and in pregnant and breastfeeding women (DELIVER/MTN-042 and B-PROTECTED/MTN-043) so that no woman or girl is left behind. And we are hopeful that our studies of a 90-day dapivirine ring (MTN-036/IPM 047) and of a 90-day ring containing both dapivirine and a contraceptive (MTN-030/IPM 041 and MTN-044/IPM 053/CCN019) will leverage IPM’s further development of these next-generation multipurpose rings.
As we look back, it is useful to reflect on the fact that the MTN was created in 2006 by the National Institute of Allergy and Infectious Diseases (NIAID), together with the Eunice Kennedy Shriver National Institute for Child Health and Human Development and the National Institute of Mental Health, with a mission to facilitate the development and approval of safe and effective products for the prevention of HIV. We are grateful that our funders had the foresight to create a structure that allowed for collaboration and participation at every level, across disciplines and by and within communities.
Where we are with the dapivirine ring is a testament that when we work together as partners, we can go further than any one of us could have gone alone, and that as a family, we can achieve what might have seemed unimaginable.
Attached to this message are press releases from IPM and MTN, and NIAID’s statement will be posted here, if not now, later this morning.
With great appreciation of your efforts and much joy at reaching this important milestone,
Sharon Hillier and Jared Baeten