How Post-Approval GMP Challenges Cooled Novo Nordisk’s Blazing Wegovy Launch
Unrelated US FDA inspection led contract manufacturer to stop filling Wegovy syringes before alternate manufacturing facilities became available.
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The Danish firm’s GLP-1 receptor agonist triggered significant weight loss in a Phase III trial in obese teenagers, sparking filing plans that could strengthen the product’s market share even as rival Eli Lilly mounts a threat with Mounjaro.
The company is targeting revenues of DKK25bn ($3.66bn) from Wegovy for obesity in 2025, with plans to amp up the US launch this year following an initial supply disruption.
While pharmaceutical manufacturing facilities can age well, the care and attention aging facilities require can arise at inopportune moments, as was the case for Novo’s Wegovy launch. Even so, Catalent aims to make quick work of air handler replacement to get the new weight-loss drug back into production, despite typically long lead times, consultant says.