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FDA Grants Accelerated Approval to Lilly’s Oral Weight-Loss Pill Foundayo

Price curbs under a Trump plan could shape uptake in a market worth an estimated $150 billion.

Overview

  • The Food and Drug Administration cleared the once-daily pill after a rapid 50-day review.
  • Eli Lilly said U.S. availability will begin soon following the authorization.
  • A study of more than 3,000 adults over roughly 16 months showed up to 11.2% weight loss, averaging about 12 kilograms, versus about 2.5 kilograms with placebo.
  • The pill is expected to fall under the Trump administration’s price agreement for weight-loss drugs, which could constrain launch pricing.
  • Analysts estimate the weight-loss drug market could reach about $150 billion a year, drawing strong interest from investors and rivals.