Organon announced that the US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for NEXPLANON (etonogestrel implant), which is indicated for use by women of reproductive potential to prevent pregnancy. The sNDA extends the duration of use of NEXPLANON for up to five years, an extension of the previous three-year indication. During the clinical trial to assess the contraceptive efficacy and safety of extended use (years four and five), no pregnancies were reported and there were no new safety findings. Additionally, the study enrolled women with a range of Body Mass Index (BMI) values (17.2 to 64.3 kg/m2), with 38.1 percent of them having a BMI ≥30 kg/m2.

“Today marks an important milestone for women seeking a highly effective long-acting reversible contraceptive option, as well as another advancement in Organon’s women’s health franchise. The sNDA approval of an extended duration up to five years, along with data about the use of NEXPLANON in women with varying BMIs, including women with overweight or obesity, is a testament to Organon’s commitment to inclusive and comprehensive women’s healthcare,” said Juan Camilo Arjona Ferreira, Head of Research and Development and Chief Medical Officer, MD, Organon.

In addition, this approval includes a new Risk Evaluation and Mitigation Strategy (REMS) programme in the US to mitigate complications due to improper insertion and removal. This REMS programme will enhance Organon’s existing Clinical Training Program (CTP) and controlled distribution programme, which has been in place since 2006, by instituting important proactive measures to certify providers in the proper insertion and removal of our product.

“The updated label for NEXPLANON reflects the diversity of patients we see every day—women throughout their reproductive ages, those seeking a long-acting option of up to five years, those who prefer birth control that goes in the arm rather than the uterus, and women across a wide range of BMIs. The REMS programme builds on existing training requirements to ensure providers maintain the highest standards for insertion and removal, reinforcing confidence and best clinical practice,” said Anita Nelson, MD, Professor, Obstetrics and Gynecology, Western University of Health Sciences.