• Maryland: FDA on Friday approved the first blood test to detect Alzheimer's, providing patients with a less expensive and less invasive alternative to medical imaging or spinal taps. The test, which was developed by Fujirebio Diagnostics, measures the plasma levels of two proteins, pTau217 and β-amyloid 1-42, before calculating the numerical ratio of the levels of these proteins to determine the presence or absence of amyloid plaques in the brain. In a clinical trial that included 499 plasma samples from adults with cognitive impairment, 91.7% of those who had a positive result from the Fujirebio test later had the presence of amyloid plaques confirmed by a PET scan or a cerebrospinal fluid (CSF) test. At the same time, 97.3% of those who received a negative result on the Fujirebio test also had a negative PET scan or CSF test. "Today's clearance is an important step for Alzheimer's disease diagnosis, making it easier and potentially more accessible for U.S. patients earlier in the disease," said Michelle Tarver, director of FDA's Center for Devices and Radiological Health. (Vinluan, MedCity News, 5/18; Goldman, Axios, 5/16)
• Maryland: FDA has approved Novavax's protein-based COVID-19 vaccine, but only for adults ages 65 and older and individuals ages 12 to 64 who have at least one medical condition that increases their complication risk from COVID-19. FDA's approval also requires Novavax to complete studies on the vaccine's association with different heart conditions, with one in individuals younger than 12 currently underway. John C. Jacobs, Novavax's CEO, said the vaccine's approval was a "significant milestone" for the company and patients. However, some health experts have expressed concerns about the new restrictions imposed by FDA, which could limit access to the vaccine for some patients. This is also the first time FDA has included health criteria for COVID-19 shots, a decision that has typically been made by CDC advisors. "I think we're left confused about what this means for the consumer," said Paul Offit, a vaccine expert from Children's Hospital of Philadelphia and an FDA advisor. "I think the goal of [HHS Secretary] Robert F. Kennedy Jr. is to make vaccines less available, more expensive and more feared. His goal is to tear away at the vaccine infrastructure, because he believes that vaccines are not beneficial and are only harmful." (Jewett/Mandavilli, New York Times, 5/17; Associated Press/MedPage Today, 5/18)
• New Jersey: Novo Nordisk CEO Lars Fruergaard Jørgensen has stepped down from the role as the company faces growing competition for its GLP-1 drugs and a steep decline in its stock price. "Considering the recent market challenges, the share price decline, and the wish from the Novo Nordisk Foundation, the Novo Nordisk Board and Lars Fruergaard Jørgensen have jointly concluded that initiating a CEO succession is in the best interest of the company and its shareholders," the company said in a statement. According to the Wall Street Journal, Jørgensen's departure as CEO underscores a change in fortune for Novo Nordisk. While the company originally dominated the GLP-1 market with Ozempic, which was introduced in 2017 for type 2 diabetes, and Wegovy, which was introduced in 2021 for obesity, it has since lost a significant share of the market to rival drugmaker Eli Lilly, which developed the GLP-1 drugs Mounjaro and Zepbound. Zepbound now generates more U.S. prescription volume than Wegovy, and studies have shown that Zepbound leads to greater weight loss than Wegovy. "While Novo took a commanding early lead in the obesity duopoly, they have ceded ground at a critical moment when more competitors are quickly approaching" said Evan David Seigerman, an analyst at BMO Capital Markets. (Loftus/Chopping, Wall Street Journal, 5/16; Bettelheim, Axios, 5/16)

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