Daily Briefing

Around the nation: FDA approves new Eli Lilly Alzheimer's drug


FDA has approved Eli Lilly's new Alzheimer's drug donanemab, making it the third amyloid-targeting drug approved for the disease since 2021, in today's bite-sized hospital and health industry news from Georgia, Maryland, and Texas. 

  • Georgia: CDC last month issued an alert to healthcare providers warning them about the growing risk of dengue fever as global cases of the mosquito-borne disease set new records. According to the agency, countries in the Americas reported twice as many cases in the first half of 2024 as they reported in all of 2023. So far, the region has reported almost 10 million cases of the virus, with many originating from outbreaks in South American countries like Brazil and Argentina. In its alert, CDC advised doctors to know the symptoms of dengue, ask questions about where patients traveled recently, and consider ordering tests for dengue when appropriate. The Florida Health Department has also issued an alert for mosquito-borne illness after two cases of dengue were discovered in the Florida Keys. The two cases were locally acquired, meaning they were not associated with any travel. (Nolen/Rosenbluth, New York Times, 6/26; Associated Press/MedPage Today, 6/25; Sforza, The Hill, 7/2)
  • Maryland: FDA last week approved Eli Lilly's Alzheimer's drug donanemab, which is now branded as Kisunla, after originally delaying the drug's approval in March. Donanemab is a monoclonal antibody that targets amyloid brain plaques. According to Eli Lilly, the drug was able to slow Alzheimer's disease progression by 35%, or roughly four months, compared to a placebo in an 18-month clinical trial with 1,700 patients. The company also noted that, unlike other Alzheimer's drugs, the treatment can be stopped after it clears amyloid from patients' brains. "This approval is emblematic of the new era of Alzheimer's research where we now have the first class of disease-modifying drugs that will eventually be used in combination with novel therapies — based on the biology of aging — that target all the underlying complexities of this disease," said Howard Fillit, from the Alzheimer's Drug Discovery Foundation. "This milestone will not only catalyze the next generation of therapies, but also reframe how we deliver treatments." According to The Hill, donanemab is the third amyloid-targeting Alzheimer's drug that has been approved since 2021. Other Alzheimer's drugs that received approval were Biogen and Eisai's Aduhelm and Leqembi. Aduhelm was discontinued in January, while Leqembi was originally approved in 2023. (Weixel, The Hill, 7/2; Belluck, New York Times, 7/2; Roubein/Gilbert, Washington Post, 7/2; George, MedPage Today, 7/2)
  • Texas: According to a new study published in JAMA Pediatrics, infant deaths in Texas increased by almost 13% after the state's six-week abortion ban went into effect in 2021. For the study, researchers analyzed all recorded infant deaths in Texas, as well as 28 comparison states. The researchers used a comparative interrupted time series analysis and national birth certificate data from January 2018 to December 2022 to estimate the difference between the number of observed and expected infant and neonatal deaths and infant death rates. Overall, there were 102,391 infant deaths nationwide between 2018 and 2022, with 10,351 deaths occurring in Texas. Between 2021 and 2022, the number of infant deaths in Texas rose from 1,985 to 2,240, an increase of 12.9%. Meanwhile, infant deaths across the rest of the United States only increased by 1.8%. There were also similar findings for the estimates of neonatal deaths, with Texas seeing an increase of 10.4% compared to 1.6% for the rest of the country. "There have been previous studies that show an association between abortion restrictions in states ... and increased infant mortality rates," said Alison Gemmill, one of the study's authors from the Bloomberg School of Public Health at Johns Hopkins University. "Here, we had the opportunity to study the causal impact of one of the most restrictive abortion policies on infant deaths to shed light on this important question." (Henderson, MedPage Today, 6/24; Merelli, STAT, 6/24)

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