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Around the nation: FDA issues first full approval for experimental Alzheimer's drug


FDA on Thursday granted full approval to Leqembi, an experimental drug that's been shown to delay cognitive decline in Alzheimer's patients, in today's bite-sized hospital and health industry news from the District of Columbia, Florida, and Illinois.

 

  • District of Columbia: FDA on Thursday granted full approval to Leqembi, an experimental drug developed by Eisai and Biogen that's been shown to delay cognitive decline in Alzheimer's patients by 27% over 18 months in clinical trials. "Today's action is the first verification that a drug targeting the underlying disease process of Alzheimer's disease has shown clinical benefit in this devastating disease," said Teresa Buracchio, acting director of FDA's office of neuroscience. CMS Administrator Chiquita Brooks-LaSure said that, following FDA's approval, CMS "will cover this medication broadly while continuing to gather data that will help us understand how the drug works." In April, the Institute for Clinical and Economic Review, said Leqembi's $26,500 price would cause "rapid growth in health care insurance costs that would threaten sustainable access to high-value care for all patients." The Institute suggested the drug be priced between $8,900 and $21,500. (González, Axios, 7/6)
  • Florida: Health officials in Florida on Thursday reported two additional cases of malaria in the state — neither of which were linked to travel outside the country — adding to the number of local malaria cases seen for the first time in 20 years. In June, CDC issued a health alert asking hospitals to watch out for patients with malaria symptoms and prepare to rapidly diagnose and treat them within 24 hours. Manuel Gordillo, an infectious disease specialist at Sarasota Memorial Hospital, said his hospital has treated four of the state's malaria patients. (Bendix, NBC News, 7/7)
  • Illinois: Medline in June named Jim Boyle as its new CEO, promoting him from EVP, effective Oct. 1. Boyle will succeed Charlie Mills who is retiring from the role but is remaining on the company's board of directors. Medline's president, Andy Mills, and its COO Jim Abrams are also retiring from their roles but will be vice chairs of the board. Medline said Jim Pigott will be its new president and COO. (Crain's Chicago Business/Modern Healthcare, 6/28)

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