GLP-1
Novartis confirms that nine patients treated with its spinal muscular atrophy gene therapy Zolgensma have developed tumors; the FDA orders GLP-1 drugmakers to add a warning to their labels about the risk of a rare eye condition that can lead to vision loss; and the agency is set to decide on no fewer than 11 therapies this month, including closely watched applications from Summit Therapeutics, Vertex and Capricor Therapeutics.
Having linked its glucagon/GLP-1 candidate to a significant reduction in heavy drinking days, Altimmune is preparing to speak to the FDA in December about the design of a Phase 3 program.
Twelve marketed drugs, including Eli Lilly’s and Novo’s weight loss mega-blockbusters, will require a label change under the new FDA update.
If approved, the oral GLP-1 would be Eli Lilly’s second marketed drug for obstructive sleep apnea after the GIP/GLP-1 injectable Zepbound secured the first approval in the space in December 2024.
With the first Phase 3 data expected for Amgen’s MariTide next year, analysts are looking for evidence that the GLP-1 candidate is tolerable. Meanwhile, the company has begun testing an autoinjector formulation.
Novo CEO Mike Maziar Doustdar insists that his company is ahead of fierce rival Eli Lilly as oral Wegovy rises to 8 million total prescriptions since its January launch.
The majority of the large pharmas have now reported third quarter earnings—spoiler alert: Eli Lilly made more money than anyone expected. Plus, the FDA dropped another initiative aimed at accelerating rare disease treatments; HHS greenlights the compounding of six unapproved peptides; and uniQure’s embattled gene therapy for Huntington’s disease has finally been accepted for review.
With the commercial business performing so well, Eli Lilly is eyeing earlier business development bets to build out a longer-term pipeline.
Eli Lilly’s shares rose 4% in early morning trading after reporting revenue of $24.4 billion, well past consensus estimates.
Posthoc analyses in women divided by menopausal status show how Novo’s next-generation GLP-1 drug affects key cohorts of patients.
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