Nearly $4 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 GIP dual agonist FDA-approved in November 2023, posted sales of $1.26 billion for the quarter. The figures do not include billions of dollars more received by the companies for their type 2 diabetes versions of each drug, Novo’s Ozempic and Lilly’s Mounjaro.

Others stay the course as Lilly quits PD-1 in RA

Eli Lilly and Co.’s recent decision to drop development at phase II of PD-1 agonist peresolimab in rheumatoid arthritis (RA) because of an inadequate benefit-risk profile brought further attention to the class in inflammation and immunology. The move also put a dent in shares of Anaptysbio Inc., set to unveil top-line week 12 data early next year with rosnilimab in moderate to severe RA. This spring, Gilead Sciences Inc. made known its plans to capitalize on the early August 2022 buyout of privately held U.K. biotech Mirobio Ltd. with the advancement of PD-1 agonist GS-0151 into phase Ib trials for RA, and the space has continued to percolate since.

GLP-1s push into MASH as semaglutide 2.4 mg hits endpoints

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. Part one results of the two-part, 240-week, double-blinded phase III Essence trial posted Nov. 1 found 37% of the semaglutide 2.4-mg-treated arm achieved a statistically significant improvement in liver fibrosis without steatohepatitis progression, compared to 22.5% achieved in the placebo arm. About 63% of patients in the semaglutide-treated arm also achieved steatohepatitis resolution without worsening of liver fibrosis, compared to 34.1% in the placebo arm.

Californians say yes to 340B accountability measure

With the U.S. Congress sitting on its hands on reforms to the 340B drug discount program, states are stepping into the gap. While most state efforts have been aimed at forcing biopharma companies to give the drug discounts to an increasing number of contract pharmacies, California is looking in a different direction. According to unofficial election results, a slim majority of voters there said yes to Proposition 34, which would require certain providers that benefit from the steep discounts on outpatient drugs to spend at least 98% of their 340B revenues on direct patient care.

Blocking CGRP in endometriosis: two birds with one stone?

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. Affecting around 10% of the global female population, and with even higher prevalence in transgender men, endometriosis remains a condition without a known preventive or curative treatment.

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