Novartis, BMS halt autoimmune CAR-T trials on safety

Good morning, healthcare professional.

Safety concerns have forced two pharmaceutical giants to pause promising cell therapy trials, while the competitive GLP-1 market sees a major label expansion and dealmaking activity continues to reshape the immunology landscape. The FDA also approved a new treatment option for patients with a rare blood cancer.

These developments highlight both the promise and perils of advancing novel therapies, the intensifying battle for metabolic disease supremacy, and the industry's continued appetite for strategic acquisitions in high-value therapeutic areas.

In today's healthcare digest:

• Novartis and Bristol Myers Squibb pause autoimmune CAR-T programs after safety signals emerge
• Eli Lilly's Mounjaro secures cardiovascular indication, escalating GLP-1 competition with Novo Nordisk
• FDA approves Takeda and Protagonist's Mimrylo for polycythemia vera
• Lilly acquires Merida Therapeutics for $2.9 billion to expand immunology pipeline

CAR-T Safety Concerns Halt Autoimmune Trials

The Recap: Novartis and Bristol Myers Squibb have paused their CAR-T cell therapy trials in autoimmune diseases following safety signals. The holds represent a significant setback for efforts to expand this cancer treatment technology beyond oncology.

• Both companies were testing CAR-T therapies targeting CD19 in conditions like lupus and myositis.
• The pauses affect programs that aimed to replicate early success seen in small autoimmune studies.
• This development raises questions about CAR-T safety profiles outside cancer settings where patients have different risk-benefit calculations.

Mounjaro Gains Heart Protection Label

The Recap: Eli Lilly secured FDA approval to expand Mounjaro's label to include reducing cardiovascular risk in type 2 diabetes patients. The approval intensifies competition with Novo Nordisk's Ozempic, which already carries a similar indication.

• The cardiovascular benefit adds substantial commercial value to Mounjaro in the multi-billion dollar GLP-1 market.
• Lilly can now promote Mounjaro's ability to reduce heart attack and stroke risk alongside glucose control.
• This approval helps differentiate Mounjaro as Lilly and Novo battle for market share in diabetes and obesity.

FDA Approves New Rare Blood Cancer Treatment

The Recap: The FDA approved Mimrylo (rusfertide), developed by Takeda and Protagonist Therapeutics, for treating polycythemia vera in adults requiring therapeutic phlebotomy. The approval provides a new option for patients with this rare blood cancer who need frequent blood removal procedures.

• Polycythemia vera causes the body to produce too many red blood cells, requiring regular phlebotomy to prevent complications.
• Mimrylo works by limiting iron availability, thereby reducing red blood cell production and phlebotomy needs.
• The approval addresses an unmet need in a patient population with limited treatment alternatives beyond bloodletting.

Lilly Acquires Immunology Biotech for $2.9B

The Recap: Eli Lilly will acquire Merida Therapeutics for $2.9 billion to gain access to experimental immunology drugs, including a treatment for Graves' disease. The deal reflects Lilly's strategy to diversify beyond its diabetes and obesity franchises.

• Merida's pipeline includes therapies targeting autoimmune conditions with significant unmet medical needs.
• The $2.9 billion price tag indicates high confidence in Merida's clinical programs and commercial potential.
• This acquisition follows a pattern of large pharma companies investing heavily in immunology assets.

The Shortlist

• AstraZeneca and Ionis detailed the unexpected failure of their RNA drug Wainua in a heart disease trial, sparking debate about combination therapy approaches.

• Priovant Therapeutics received FDA approval for Lisraya (brepocitinib) to treat a rare and severe skin disease.

• The White House announced nine new drug pricing agreements with mid-sized pharmaceutical manufacturers under its most-favored-nation pricing initiative.

• Jazz Pharmaceuticals reported positive survival data for Ziihera in HER2-positive stomach cancer, strengthening its oncology portfolio.

• Moderna raised $2.6 billion to support its cancer vaccine programs as the FDA cleared updated COVID-19 vaccines from multiple manufacturers.