Daily Briefing

Around the nation: FDA advisors recommend approval of experimental ALS drug


FDA's Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) voted 7-2 to recommend approval of an experimental ALS drug, in today's bite-sized hospital and health industry news from Illinois and Maryland.

  • Illinois: Walgreens Boots Alliance late last month finalized a $330 million deal to purchase a majority share in CareCentrix. The deal, which was initially announced last October, gives Walgreens a 55% share in CareCentrix with an option to purchase the remaining shares in the future. According to Walgreens, the investment expands its capabilities to assist patients with their transition from hospitals to their home. "We created Walgreens Health to reimagine local healthcare and wellbeing for all," said Walgreens CEO Roz Brewer. "This partnership advances our ability to address the needs of people across care settings immediately following hospital discharge. Our collaboration with CareCentrix is one of the many ways we are expanding on our pharmacy and patient expertise to surround individuals with care when and how they need it." (Christ, Modern Healthcare, 8/31; Japsen, Forbes, 8/31)
  • Maryland: FDA's PCNS committee on Wednesday voted 7-2 to recommend approval of Amylyx's experimental ALS drug—a significant reversal from the committee's 6-4 vote against the drug's approval in late March. Previously, the committee voted against the drug's approval after they decided that the evidence from a single clinical trial with only 137 patients did not adequately show the drug, AMX0035, slowed the disease. However, several advisors on Wednesday changed their vote after additional analyses submitted by the drug's manufacturer strengthened the case for approval. In addition, some of the advisors were convinced by a promise from Amylyx CEO Justin Klee's promise to pull the drug from the market if a larger study, with 600 patients, does not demonstrate the drug's effectiveness. "[W]e will do what is right for patients, which includes withdrawing the product from the market," Klee said. FDA, which typically follows advisors' recommendations, is expected decide on the drug's approval by Sept. 29. (McGinley, Washington Post, 9/7)
  • Maryland: CMS on Tuesday issued a notice informing Medicare prescription drug plan sponsors that they will be required to ensure that their enrollee materials are compliant with the Inflation Reduction Act before the next enrollment period, which begins Oct. 15 and ends Dec. 7. Insurers will be required to notify enrollees about certain provisions in the legislation no later than Sept. 30, including cost-sharing for insulin and eliminating out-of-pocket costs for vaccines under Part D. In addition, they will be required to distribute updated benefit summaries and update their websites no later than Oct. 15. The agency also recommended that insurers review all beneficiary communications to ensure compliance with the law. (Goldman, Modern Healthcare, 9/6)

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