Organon announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for its Nexplanon birth control implant to extended its use for up to five years. It was previously indicated for up to three years.

In the clinical trial to evaluate contraceptive efficacy and safety of extended use, no pregnancies were reported and there were no new safety findings. The study enrolled women with a a range of body mass index (BMI) values (17.2 to 64.3 kg/m2), with 38.1% of them having a BMI ≥30 kg/m².

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

“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,” said Organon’s head of R&D and chief medical officer, Juan Camilo Arjona Ferreira, MD. “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.”

“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,” added Anita Nelson, MD, professor, Obstetrics and Gynecology at Western University of Health Sciences. “The REMS program builds on existing training requirements to ensure providers maintain the highest standards for insertion and removal, reinforcing confidence and best clinical practice.”

In November, the company began a deal to sell its JADA system to Laborie Medical in a transaction valued at up to $465 million.