Metabolic health is at an odd juncture. With the advent of glucagon-like peptide (GLP-1) agonists, pharmacologically induced weight loss has matured into a viable therapeutic option at long last. GLP-1R agonists, which are also called incretin mimetics and GLP-1 analogs, are likely to continue their success across multiple areas of medical care. Already, the class has transformed diabetes care, making a splash in weight management, and it may yet do the same for other indications. In 2005, Byetta (exenatide, Astrazeneca plc) was the first GLP-1 receptor agonist to be approved by the U.S. FDA for the treatment of type 2 diabetes. Since then, four others have followed.
The BioWorld Insider Podcast: Fitness may be more directly linked to health than weight
After many years of research and development, drug-induced weight loss has matured into a viable therapeutic option. But do the drugs directly help people become healthier or is it the weight loss? There are longstanding concerns that the health effects of weight might be overrated. And new studies show fitness improves health outside of weight. So, can a person still be considered healthy despite being over a “normal” weight? How will future medical science consider what is called the obesity epidemic? In this edition of the BioWorld Insider podcast, BioWorld Science Managing Editor Anette Breindl, discusses her new analysis of multiple studies related to weight loss, metabolic health and fitness which in many ways goes against the mainstream health care state of mind about obesity.
First oral SERD cleared for breast cancer: FDA approves Menarini’s Orserdu
Winning the race to market with the first oral selective estrogen receptor degrader (SERD) for breast cancer is Menarini Group’s elacestrant, which gained U.S. FDA approval for use as second- and third-line therapy in patients with ER-positive/HER2-negative advanced or metastatic disease with the ESR1 mutation. It marks the first therapy approved specifically targeting ESR1, found in up to 40% of patients with ER-positive/HER2-negative disease. Branded Orserdu, the drug’s nod came a few weeks ahead of its Feb. 17, 2023, PDUFA date. Menarini’s New York-based subsidiary, Stemline Therapeutics, will commercialize the drug in the U.S.
China approves two oral drugs to treat COVID-19
China’s NMPA granted conditional approvals to two COVID-19 drugs under a special examination and approval procedure aimed at addressing urgent needs. The approvals are both for oral small-molecule drugs for adult patients with mild to moderate COVID-19 infections. One of the approved drugs is Simcere Pharmaceutical Group Ltd.’s Xiannuoxin (simnotrelvir/ritonavir). The other is Shanghai Junshi Biosciences Co. Ltd.’s VV-116 (deuremidevir hydrobromide).
US FTC asked to scrutinize, oppose biopharma M&As
Citing “rampant consolidation” in the biopharma industry, Sen. Elizabeth Warren (D-Mass.) is taking aim at the current trend of Big Pharma shifting from in-house innovation to acquisition. In a letter last week to the Federal Trade Commission (FTC), Warren urged the agency to “oppose any big pharma acquisition that will threaten competition, reduce innovation or increase costs for American families.” In particular, she wants the FTC to scrutinize pending deals involving Amgen Inc.’s $27.8 billion acquisition of Horizon Therapeutics plc and Indivior plc’s acquisition of Opiant Pharmaceuticals Inc.
Equilibre’s anti-inflammatory sees phase II success in epilepsy
Equilibre Biopharmaceuticals Corp. has positive top-line data from the phase II study of its lead asset, EQU-001, an anti-inflammatory adjunctive therapy for treating focal seizures for adults with epilepsy. The dose-finding study, which was not powered for efficacy, according to the company, demonstrated a dose-dependent decrease in per 28-day focal seizure frequency compared to placebo. The data showed a 35.7% median reduction over placebo in the 60-mg treatment arm. Also, a greater number of patients had a 50% or more reduction in per 28-day focal seizure frequency in the 60-mg treatment arm when compared with placebo.
Phase IIb Origin data in IgAN unveiled by Vera; phase III ahead
Vera Therapeutics Inc. unveiled results from the prespecified per-protocol (PP) analysis of the phase IIb Origin trial with atacicept in patients with IgA nephropathy (IgAN). The news follows top-line data disclosed at the start of this month. PP results showed a 41% absolute urine protein creatinine ratio reduction from baseline with 150 mg at 24 weeks and 48% in interim 36-week data. Brisbane, Calif.-based Vera is planning to launch a phase III study in IgAN in the first half of this year. Shares (NASDAQ:VERA) were trading midday at $8.18, down 56 cents.
FDA grants breakthrough therapy designation to Abbisko’s CSF-1R inhibitor, pimicotinib
The U.S. FDA granted breakthrough therapy designation to Abbisko Therapeutics Co Ltd.’s colony-stimulating factor 1 receptor (CSF-1R) inhibitor, pimicotinib, for patients with tenosynovial giant cell tumors who are not able to have surgery. Internally discovered and developed by Abbisko, of Shanghai, China, pimicotinib (ABSK-021) is an orally bioavailable, selective, small molecule.
Also in the news
Alto, Amarin, Arcellx, Argenx, Astrazeneca, Avenue, Bioaegis, Bioarctic, Bloomsbury Genetic Therapies, Bristol Myers Squibb, Centessa, Eisai, Eli Lilly, Exegi, Index, Inhibikase, Ipsen, Janssen, Johnson & Johnson, Kite, Marengo, Merck, Orion, Pliant, Precigen, Ribon, Sana, Sanofi, Scpharmaceuticals, Skye, Structure, Summit, Vera, Viatris