Core Viewpoint - Novo Nordisk is seeking accelerated review for a higher dose version of its obesity drug Wegovy (semaglutide) through the FDA's CNPV program, which could lead to approval within one to two months, coinciding with the review of its 25 mg oral semaglutide in Q4 [2][6]. Group 1: Drug Efficacy and Approval Process - The new 7.2 mg dose of semaglutide is expected to provide a more effective weight loss option, with clinical trial results showing an average weight loss of 20.7% over 72 weeks compared to 17.5% for the 2.4 mg group and 2.4% for the placebo group [2][3]. - In the 7.2 mg trial group, 33.2% of participants achieved at least a 25% weight loss, compared to 16.7% in the 2.4 mg group and 0% in the placebo group [3]. - The FDA has issued 15 CNPV designations to date, with Wegovy being among the second batch of drugs selected for this expedited review process [5]. Group 2: CNPV Controversy - Concerns regarding the CNPV program have been raised by lawmakers, questioning its potential to benefit pharmaceutical companies with close ties to the Trump administration and demanding transparency on the beneficiaries and review details [7][10]. - There are fears that the accelerated review process may undermine public trust in FDA decisions, especially in light of staffing cuts within the government [9]. - Reports indicate that the initial CNPV review process excluded the FDA team responsible for evaluations, leading to concerns about the legitimacy and pace of the decision-making [10].