On 20 March 2026, Novo Nordisk announced that the FDA has approved its 7.2mg semaglutide injection, Wegovy® HD, for the reduction of excess body weight and maintenance of weight reduction long-term. The high dose formulation is expected to be launched in the US in a single dose pen in April 2026.
Wegovy® HD received accelerated approval under the FDA Commissioner’s National Priority Voucher (CNPV) pilot program, which accelerates review and approval of products that align with a certain critical US national health priority. Novo Nordisk’s supplemental New Drug Application for the product was submitted in November 2025.
Wegovy® 7.2mg has been approved in the EU (positive CHMP recommendation in December 2025, European Commission approved February 2026) and the UK (approved January 2026) as maintenance doses for adults with obesity. Novo Nordisk expects regulatory decisions in the EU and the UK regarding a single-dose 7.2mg semaglutide pen in the second half of 2026.