Organon’s Nexplanon implant for preventing unwanted pregnancy can now be used for up to five years after the company gained US Food and Drug Administration (FDA) approval on a supplemental New Drug Application (sNDA).
Extending the drug-device combination’s use from three years, Organon’s sNDA approval was supported by data from a trial that evaluated Nexplanon’s efficacy in patients who had been using it for at least 36 months at the time of enrolment.
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Nexplanon works by releasing a low dose of the hormone etonogestrel, a synthetic progestin, from a small rod inserted under the skin. The hormone stops ovulation, thickens cervical mucus to block sperm, and thins the uterine lining – all of which help to prevent pregnancy.
The trial’s primary endpoint was the Pearl Index (PI) at years four and five, with no pregnancies reported during this period. Of the 399 women evaluated, the trial’s catchment included a range of body mass index (BMI) values ranging from 17.2- to 64.3kg/m2), with 38.1% of the enrolled with a BMI above 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,” said Juan Camilo Arjona Ferreira, Organon’s chief medical officer and head of research and development.
“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,” Arjona Ferreira continued.
According to past research by the US Centers for Disease Control and Prevention (CDC), the use of long-acting reversible contraception (LARC) methods such as Nexplanon among US teenagers are on the rise. CDC data reflected that LARC methods’ use in the 15-19 age demographic stood at 5.8% between 2011-2015, and 19.2% from 2015-2020.
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By GlobalDataOrganon is on track towards tightening its focus on its women’s health portfolio, as reflected by the company’s recent divestment of its JADA post-partum haemorrhage (PPH) treatment system to Laborie Medical in a deal valued at up to $465m in November 2025.
Organon’s interim CEO Joseph Morrissey said at the time that JADA’s sale would help the company narrow its focus to its women’s health biopharma offerings, as well as help to realise capacity on its balance sheet. Organon span off from MSD in 2021, inheriting debt of around $9.5bn. According to the company’s Q3 2025 financials, its debt remains at $8.83bn.
Morrissey stepped in as Organon’s interim CEO after Kevin Ali stepped down from the CEO role in October 2025 following a board probe that uncovered “improper” wholesaler sales practices.
