Novo Nordisk, Eli Lilly, AstraZeneca, Daiichi Sankyo, Pfizer, and Sanofi all made headlines this week with key developments in their respective pipelines. These updates span obesity treatments, regulatory approvals, and strategic decisions impacting the pharmaceutical landscape.
Novo Nordisk's CagriSema Obesity Treatment Shows Disappointing Results
Novo Nordisk (NVO) announced top-line data from its Phase III REDEFINE 1 study evaluating CagriSema, a next-generation subcutaneous obesity treatment candidate. CagriSema is a fixed-dose combination of cagrilintide (2.4 mg), a long-acting amylin analogue, and semaglutide (2.4 mg). The study met its primary endpoint, demonstrating a 22.7% weight loss after 68 weeks compared to 11.8% with cagrilintide, 16.1% with semaglutide, and 2.3% with placebo alone. However, this result fell short of the company's previous guidance of 25% weight loss, leading to a decline in Novo Nordisk's stock price.
FDA Approves Lilly’s Zepbound for Sleep Apnea
Eli Lilly (LLY) received FDA approval for Zepbound (tirzepatide) for moderate-to-severe obstructive sleep apnea (OSA). This approval marks Zepbound as the first and only prescription drug for adults with obesity-related OSA. The approval was based on data from the SURMOUNT-OSA Phase III studies. Zepbound's regulatory application is also under review in the EU.
AstraZeneca and Daiichi Sankyo Withdraw Dato-DXd Application in EU, Pursue U.S. Approval
AstraZeneca (AZN) and Daiichi Sankyo voluntarily withdrew their marketing authorization application (MAA) in the EU for datopotamab deruxtecan (Dato-DXd) for non-squamous non-small cell lung cancer (NSCLC), based on the recommendation of the European Medicines Agency (EMA). The application was based on the TROPION-Lung01 Phase III study. In the United States, the companies withdrew their earlier application for accelerated approval of Dato-DXd for non-squamous NSCLC and instead filed a new biologics license application (BLA) for Dato-DXd for previously treated advanced EGFR-mutated NSCLC, based on the TROPION-Lung05 Phase II study. They are also seeking approval for Dato-DXd for HR+ HER2- breast cancer in both the United States and the EU. AstraZeneca's Tagrisso was approved in the EU for an expanded use in unresectable EGFR-mutated NSCLC with exon 19 deletions or exon 21 (L858R) mutations, based on the Phase III LAURA study.
Pfizer’s Braftovi Approved for First-Line Colorectal Cancer
The FDA approved Pfizer’s (PFE) Braftovi in combination with Erbitux (cetuximab) and mFOLFOX6 as a first-line treatment for metastatic colorectal cancer with BRAF mutations. The approval was based on data from the Phase III BREAKWATER study. Braftovi, in combination with Erbitux, was previously approved for BRAF-mutated metastatic colorectal cancer in patients who had received prior therapy.
Sanofi and SK bioscience Expand Pneumococcal Vaccine Collaboration
Sanofi (SNY) and SK bioscience announced the commencement of a Phase III program for their partnered 21-valent pneumococcal conjugate vaccine (PCV21). They also expanded their agreement to develop, license, and commercialize next-generation PCVs for treating invasive pneumococcal disease (IPD) in pediatric and adult patient populations. Sanofi will make an upfront payment of €50 million to SK bioscience, with the latter eligible for further development and commercial milestone payments.
