Lilly Settles On Rolling Submission For Tirzepatide In Obesity
Plan for rolling submission means US FDA filing of GIP/GLP1 agonist in obesity could be complete by April 2023, setting up possibility of late 2023 approval.
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The pharma is increasing its manufacturing capacity for tirzepatide, mindful of its potential in a second indication of obesity and the supply issues faced by competitor Novo Nordisk.
With Lilly’s sales narrative hampered by global price pressures, Lilly CEO David Ricks again criticized drug price negotiation proposals before Congress. Mounjaro launch offers a bright spot, exceeding projections.
Danish pharma says it will not market the weight-loss formulation of semaglutide until manufacturing can meet demand. Novo has seen significant growth in GLP-1 franchise in both diabetes and obesity.