Nearly $3.8 billion was earned by Novo Nordisk A/S and Eli Lilly and Co. in the third quarter for their glucagon-like peptide-1 (GLP-1) drugs to treat obesity. Novo’s GLP-1 drug, Wegovy (semaglutide), approved by the U.S. FDA in June 2021, had sales of DKK17.3 billion (US$2.5 billion), while Lilly’s Zepbound (tirzepatide), which is a GLP-1 and glucose-dependent insulinotropic polypeptide dual agonist FDA-approved in November 2023, posted sales of $1.26 billion for the quarter.
Positive findings from a phase III trial of semaglutide in metabolic dysfunction-associated steatohepatitis (MASH) is moving Novo Nordisk A/S to expand the glucagon-like peptide-1 (GLP-1) agonist’s indications in the U.S. and Europe, the Danish pharma said, as the MASH field sights more novel therapies.
Researchers at Harvard Medical School have found that blocking the neuron-released peptide CGRP decreases pain sensitivity and reduces lesion size in endometriosis. Endometriosis is a painful, steroid-dependent inflammatory condition in which tissue similar to that of the endometrial lining grows and establishes outside the uterine mucosa.
Equillium Inc. plans to continue on its own with itolizumab – now the top pipeline priority – as Ono Pharmaceutical Co. Ltd. Is letting expire the option for rights to the monoclonal antibody, designed to target the CD6-ALCAM signaling pathway.
The second time around wasn’t lovelier for Lexicon Pharmaceuticals Inc. as it once again made its case before the U.S. FDA’s Endocrinologic and Metabolic Drugs Advisory Committee for Zynquista (sotagliflozin) as an adjunct to insulin to improve glycemic control in people with type 1 diabetes and mild to moderate chronic kidney disease.
Lexicon Pharmaceuticals Inc. is counting on the Oct. 31 meeting of the U.S. FDA’s Endocrinologic and Metabolic Drugs Advisory Committee to help it break through the type 1 diabetes (T1D) door with Zynquista (sotagliflozin), proposed as an adjunct to insulin to improve glycemic control in people with T1D and mild to moderate chronic kidney disease.
While there is tremendous enthusiasm for GLP-1 drugs for use in obesity, and 80% of the U.S. population is eligible to use the therapies, tremendous obstacles continue to block their access. The blockages include high prices that consumers currently cannot afford coupled with employer health plans that don’t offer the new treatments. A panel discussing the future of GLP-1s at the BioFuture 2024 conference in New York said the next five years will see enormous changes in the way these drugs are prescribed by physicians and used by patients.
After missing out on the glucagon-like peptide 1 obesity market, Sanofi SA is prospecting for next-generation drugs and is making a strategic equity investment in Resalis Therapeutics Srl, providing the Italian biotech with funding to take its lead program RES-010 through to phase II.
The approval of Ascendis Pharma A/S’ hormone replacement therapy Yorvipath (palopegteriparatide) hypoparathyroidism – the first and only treatment for adults with the rare endocrine disease – did little to sate the market’s appetite for new drugs in the indication, where a number of players are busy in various stages of development.
Camurus AB received a complete response letter (CRL) from the U.S. FDA for CAM-2029 (octreotide), its extended-release injection for acromegaly, due to “facility-related deficiencies” identified during a cGMP inspection of a third-party manufacturer. The Lund, Sweden-based company noted that the CRL did not indicate any concerns related to clinical efficacy or safety. Camurus will work with the FDA and the third-party manufacturer to address the concerns, said Fredrik Tiberg, president and CEO.
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