How Post-Approval GMP Challenges Cooled Novo Nordisk’s Blazing Wegovy Launch

05 Jan 2022

Unrelated US FDA inspection led contract manufacturer to stop filling Wegovy syringes before alternate manufacturing facilities became available.

Syringe filling operations — the syringes must be filled before the prescriptions can be filled • Source: Alamy

Novo Nordisk A/S’s US obesity sales force had just gathered in Las Vegas, NV, to prepare for the launch of its Wegovy (semaglutide) weight-loss drug when the company learned on 17 December that it would produce very little new product for at least six months due to manufacturing quality issues.

Initial sales exceeded all expectations. But production sharply declined after the contract manufacturing organization chosen for initial production responded to...