FDA Extends Duration of Use for Nexplanon

On Jan. 16, 2026, the US Food and Drug Administration (FDA) extended the duration of use for Nexplanon^® (etonogestrel implant – Organon) 68mg radiopaque, from three to five years for the prevention of pregnancy in women of reproductive potential. Nexplanon is a long‑acting, reversible, progestin‑only contraceptive implant placed under the skin of the upper arm that continuously releases hormone to prevent pregnancy. Approval was supported by results from a clinical trial evaluating years four and five of use, during which no pregnancies occurred, and no new safety findings were identified. The trial included participants across a broad body mass index (BMI) range, with 38.1% having a BMI ≥30kg/m², reinforcing efficacy in populations often underrepresented in contraceptive studies. The FDA also approved a new Risk Evaluation and Mitigation Strategy (REMS) program to mitigate risks related to insertion and removal, enhancing provider training and safety oversight. The recommended administration remains a single subdermal implant inserted by a certified healthcare provider. Here is the updated prescribing information.

Withdrawal

Valneva Withdraws Filing for Chikungunya Vaccine Following FDA Safety Concerns On Jan. 19, 2026, Valnevavoluntarily withdrew its US biologics license application (BLA) and investigational new drug (IND) application for Ixchiq^® (chikungunya vaccine) its single‑shot live‑attenuated chikungunya vaccine, after the FDA issued a new clinical hold on the program due to a newly reported serious adverse event occurring outside the US. The event may be plausibly related to vaccination, though causality remains undetermined; it adds to previously documented safety concerns and the clinical hold issued in August 2025. Ixchiq originally received accelerated approval in November 2023 as the first chikungunya vaccine for adults at increased risk of exposure. Although Valneva will continue its post‑marketing clinical commitments and remains engaged with regulators in Europe, Canada, the U.K., and Brazil, the company has confirmed it will not reintroduce Ixchiq to the US market. Bavarian Nordic’s Vimkunya^™ is now the only vaccine available in the US to prevent infection with the chikungunya virus.