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Metabolic Disorders
Novo is making Wegovy available through a new direct-to-patient delivery option for individuals paying out of pocket for the obesity drug as the potential end of semaglutide compounding nears.
AbbVie is the latest big pharma to buy into the obesity space, licensing an amylin analog from Gubra for $350m up front, while Novo will pursue cardiometabolic targets with Gensaic’s AI-based platform.
The European Medicines Agency is considering whether apitegromab, brensocatib and diazoxide choline, from Scholar, Insmed and Soleno respectively, are drugs that are of potential major public health interest, particularly from the point of view of therapeutic innovation.
Amylin analogs could well match the weight loss seen with Novo Nordisk and Eli Lilly’s GLP-1-based blockbusters with less fewer tolerability issues. The Danish company believes petrelintide will lead the pack and is vetting potential big pharma partners very carefully.
Recent court cases initiated by the Swiss medicines regulator against “unbalanced” media reporting on GLP-1 drugs for weight loss highlights its zero tolerance for any form of misinformation that compromises patient safety.
GSK’s depemokimab, if approved, could become the first ultra-long-acting drug for treating asthma and chronic rhinosinusitis with nasal polyps. Meanwhile, Sanofi’s teplizumab, which the US approved as the first disease-modifying therapy for type 1 diabetes in 2022, has now been filed for review by the European Medicines Agency.
Amgen saw revenue rise 19% to $33.4bn in 2024 and said revenue should grow to $34.3bn-$35.7bn in 2025 despite losing exclusivity for its biggest franchise – Prolia and Xgeva (denosumab) – this year.
Lilly’s revenue is rising rapidly based on its successes in diabetes and obesity, and the company is reinvesting in big plays in those markets as well as in cancer, lipid-lowering and other indications.
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
Despite significant investments in weight loss treatments, pharmaceutical companies face criticism for neglecting to study their drugs in obese patients, possibly leading to incomplete labeling and patient risks, prompting calls for the FDA to enforce more inclusive clinical trials and updated drug information.