In a sea of uncertainty, a large-scale, long-term Swedish study is the first to show that people using GLP-1 receptor agonists are less likely to have worsening mental illness. The study involved a national cohort of 95,490 people diagnosed with depression or anxiety disorder, who also were treated with any diabetes drug (apart from insulin).
Shares in Novo Nordisk A/S took another battering after the company announced its next-generation obesity drug Cagrisema failed to show noninferiority to Eli Lilly and Co. Inc.’s Zepbound in an open-label comparator study.
At a recent Cabinet meeting, U.S. Health and Human Services (HHS) Secretary Robert Kennedy reportedly said he expected Trumprx to probably go live within 10 days. That was Jan. 29, two days before HHS was once again forced to shut down many of its activities due to a congressional gridlock over a fiscal 2026 appropriations package to keep the department and several others open beyond Jan. 30.
Years after approving three glucagon-like peptide-1 (GLP-1) receptor agonists to treat obesity, the U.S. FDA is acknowledging that the drugs don’t have the same risk seen with older weight-loss medicines. Citing its post-market evaluation that found no increased risk of suicidal ideation or behavior, the U.S. FDA is requesting that the risk be removed from the warnings and precautions section of labeling for the GLP-1 obesity drugs – Eli Lilly and Co.’s Zepbound (tirzepatide) and Novo Nordisk A/S’ Saxenda (liraglutide) and Wegovy (semaglutide).
Biopharma industry zeal for obesity therapeutics does not appear to be dying down any time soon, with Eli Lilly and Co. entering a $1.3 billion deal with Nimbus Therapeutics LLC for a new small molecule, and Arrowhead Pharmaceuticals Inc. rolling out phase I/IIa data of its RNAi therapeutics used in combination with Lilly’s GLP-1/GIP receptor agonist tirzepatide.
In a threshold event in the U.S., Medicare is planning to break through its obesity coverage barrier with a voluntary test of a model designed to enable Medicare Part D plans and state Medicaid programs to cover GLP-1 drugs prescribed for weight management.
Eli Lilly and Co. took another step toward adding a way for patients to hang onto their weight loss when the firm disclosed positive top-line data from the phase III Attain-Maintain trial with orforglipron, a once-daily oral small molecule GLP-1 receptor agonist. Indianapolis-based Lilly said that at one year orforglipron met the primary and all key secondary endpoints vs. placebo, delivering superior weight maintenance as an adjunct to a healthy diet and physical activity, using the efficacy estimand and modified treatment-regimen estimand.
The U.S. Centers for Medicare & Medicaid Services (CMS) rolled out negotiated costs of the second batch of drugs subject to such bargaining under the Inflation Reduction Act. Wall Street was not surprised to learn that the numbers amount to much greater cuts than the Biden administration managed for 2026. CMS said the adjusted maximum fair prices would have achieved 44% lower net spending had they been implemented in 2024 – 36% if forgiven discounts from the part D redesign of the Medicare prescription drug benefit are figured in. Fifteen drugs are listed.
Hailing it as a win-win and a historic step forward in fighting chronic disease, the Trump administration announced pricing agreements Nov. 6 with Eli Lilly and Co. and Novo Nordisk A/S that will expand the availability of the companies’ weight loss drugs by cutting prices and, for the first time, providing coverage for the drugs in obesity through Medicare and Medicaid.
Phase IIb data of Metsera Inc.’s lead GLP-1 receptor agonist, MET-097i, showed significant weight loss and good tolerability, supporting a phase III start later this year, and validating Pfizer Inc.’s decision a week ago to buy the obesity-focused company for $7.3 billion.
