Mifepristone is an anti-progestin that blocks the activityof progesterone, the hormone which is needed to maintain a pregnancy.Mifepristone also plays a role in softening and dilating the cervix and thushas been used for cervical ripening prior to medical procedures. It is mostcommonly known for its use in combination with the drug misoprostol to induceabortion. The safety and efficacy of mifepristone for first trimester abortionhas been well documented and its use for this purpose has expanded greatly overthe past two decades.
… Nonetheless, while mifepristone is registered more than 68countries for first trimester abortion, it is not always available or used.Additionally, given its anti-progestin and cervical ripening properties,mifepristone can be used for alternative indications both in reproductivehealth and other therapeutic areas. However, there have been limited efforts topursue labeling for non-abortion indications (although, the innovator product,Mifegyne®, is registered for four indications). For these reasons, mifepristoneis a highly under-utilized medication, specifically for improving women’shealth, and this underutilization threatens market sustainability…
Mifepristone registration for indications other than firsttrimester abortion has the potential to… facilitate greater commodity access inrestricted settings. Furthermore, expanding registration has the potential tomove mifepristone from its status as an “abortion drug” used only by abortionproviders to being known as a medication for improving women’s health, used bya broad range of health care providers. More indications could also increasedemand, and… may in turn generate interest by pharmaceutical companies topursue its marketing and distribution…
Gynuity Health Projects has worked for almost two decades todevelop clinical evidence on the safety and efficacy of mifepristone forindications outside of first trimester abortion… Indications include earlypregnancy loss, intra-uterine fetal death, cervical ripening, second trimesterabortion for maternal health or fetal indication, and menstrual regulation.These indications are legal and less politically and culturally sensitive inmost relevant jurisdictions, and, in turn, registration may not pose the sameproblems as have been encountered for registration for first trimester electiveabortion. Further, registration provides an entry point for mifepristone to beadded to national drug registries, stocked in hospitals and other health carefacilities, and integrated into health care systems. We conducted a landscapeanalysis of the registration and marketing feasibility for alternativemifepristone indications in six countries [Burkina Faso, Colombia, Kenya,Latvia, Pakistan, Senegal] with limited abortion availability… to identify theindication(s) with the greatest promise for registration and recommendationsfor what steps would help to move registration forward successfully as well as ensureavailability and use post-approval.
FULLREPORT: 2019 ; Summaryin Spanish