July 9, 2021

Around the nation: FDA narrows historic Alzheimer's drug label

Daily Briefing

    On Thursday, FDA narrowed its approval for Biogen's Alzheimer's drug Aduhelm to only patients with early-stage symptoms of the disease, in today's bite-sized hospital and health industry news from Maryland and Missouri.

    • FDA on Thursday revised its approval for Biogen's Alzheimer's drug Aduhelm, narrowing its previous recommendation that the drug be available to all Alzheimer's patient to, now, only patients with early-stage symptoms of the disease. Alfred Sandrock, head of research and development at Biogen, said the company requested the revision "[b]ased on our ongoing conversations with prescribing physicians, FDA, and patient advocates … to further clarify the patient population that was studied across the three Aduhelm clinical trials that supported approval." According to the New York Times, this revision—which reduces the number of Americans considered eligible for the drug from around six million to 1.5 million—does not bar physicians from prescribing it as they see fit, but it increases the likelihood that Medicare and private insurers will limit coverage of the drug to only the indicated patient population. (Robbins/Belluck, New York Times, 7/8; McGinley, Washington Post, 7/8; Herman, Axios, 7/8; Vinluan, MedCity News, 7/8; Walker, Wall Street Journal, 7/8)
    • Maryland: Gov. Larry Hogan (R) on Wednesday announced the state will offer college scholarships to incentivize teenagers to get vaccinated. This scholarship promotion follows the state's $2 million lottery program, which wrapped up last weekend, The Hill reports. The VaxU Scholarship Promotion plans to randomly select 20 vaccinated students to receive $50,000 scholarships, which would cover four years of tuition and fees at a public university or college. The scholarship can also be transferred to private or out-of-state schools. Students between the ages of 12 and 17 who are vaccinated in Maryland, not at federal facilities, and provide a Maryland address are automatically entered. The promotion will begin on July 12 and run for eight weeks, with two winners picked each Monday and four winners picked on Labor Day. "Promotions like this are just one more way that we are reinforcing the importance of getting every single Marylander that we can vaccinated against Covid-19, especially our young people," Hogan said. (Weixel, The Hill, 7/7)
    • Missouri: Mercy, a health system that operates over 40 hospitals and 900 physician practices and outpatient facilities in four states, announced Wednesday that it will require all employees to be fully vaccinated against Covid-19 by September 30. The mandate comes as the delta variant spreads rapidly in Missouri and strains hospitals in different areas of the state, according to Mercy officials. The health system joins three others with facilities in the state—SSM Health, BJC HealthCare, and St. Luke's Hospital—as well as 20 others nationwide in enacting Covid-19 vaccination mandates. (Masson, Becker's Hospital Review, 7/7; Barr, St. Louis Business Journal, 7/7)

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