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FDA Clears 7.2‑mg Wegovy as India Enters Generic Semaglutide Era

Wider access raises the need for sustained therapy with careful monitoring.

Overview

  • The FDA approved Wegovy HD, a 7.2‑mg once‑weekly semaglutide for adults with obesity who need additional weight loss after tolerating 2.4 mg, with U.S. availability expected in April under an expedited review program.
  • In 72‑week trials, the higher dose produced about 19% to 21% mean weight loss but showed increased adverse events, including altered skin sensations reported by 22% on 7.2 mg versus 6% on 2.4 mg.
  • Novo Nordisk’s semaglutide patent expired in India on Friday, triggering plans by more than 40 companies to launch over 50 branded generics that analysts expect to cut monthly costs to roughly ₹3,000–₹5,000 initially and potentially ₹1,500–₹2,500 over time.
  • Doctors and analysts warn that a rapid influx of low‑cost brands could drive misuse, poor dose titration, unmanaged side effects and uneven quality, increasing pressure for stronger prescribing oversight and post‑marketing surveillance.
  • New research is reshaping clinical guidance, with a Washington University study linking GLP‑1 treatment gaps to higher risks of heart attack, stroke and death, a Lancet Psychiatry registry analysis associating semaglutide with lower worsening of depression and anxiety, and Eli Lilly reporting late‑stage diabetes data for retatrutide showing A1c reductions of about 1.7%–2.0% and substantial weight loss.