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UK approves Eli Lilly's weight-loss pill; EU access lags

Created at 10 Aug · 4:06 PM1 source↑ Market-relevant
IN SHORT

The UK's medicines regulator has approved Eli Lilly's oral weight-loss drug Foundayo, marking the first European license for the medication. Access in the EU is not expected until next year, while a decision on NHS coverage in the UK is due in November.

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Key Numbers

November 18NICE decision date for Foundayo coverage

Who's Involved

Eli Lilly
Pharmaceutical company whose weight-loss pill Foundayo was approved in the UK
Medicines and Healthcare products Regulatory Agency (MHRA)
UK regulator that approved Foundayo
National Institute for Health and Care Excellence (NICE)
UK body to decide on NHS coverage for Foundayo
Novo Nordisk
Competitor company with GLP-1 pill Wegovy
Mike Doustdar
CEO of Novo Nordisk
UK approves Eli Lilly's weight-loss pill; EU access lags

↳ Why This Matters

The approval of Foundayo in the UK signifies a significant step in the availability of oral weight-loss medications in Europe, potentially increasing competition and patient access, while highlighting differing pricing and regulatory approaches between the UK, EU, and US.

Key facts

  • The UK's MHRA approved Eli Lilly's oral weight-loss drug Foundayo.
  • Foundayo is approved for weight management and type 2 diabetes.
  • This is the first European regulatory approval for Foundayo.
  • EU regulatory decisions for Foundayo are not expected until 2025.
  • The UK's NICE will decide on NHS coverage for Foundayo by November 18.
  • The U.K.'s medicines regulator has approved Eli Lilly's oral weight-loss pill, Foundayo (orforglipron), marking the first European regulatory license for the drug. The pill is approved for weight management and type 2 diabetes.

    Access to Foundayo in the European Union is not anticipated until next year. Meanwhile, the U.K.'s National Institute for Health and Care Excellence (NICE) is expected to make a decision on whether the National Health Service will cover the drug by November 18.

    Foundayo represents Eli Lilly's first oral entry into the popular GLP-1 drug class, which has seen surging demand. Its injectable drug, Mounjaro, has also benefited from this trend. The arrival of competitor Novo Nordisk's oral GLP-1 pill, Wegovy, in the U.S. and U.K. this year is expected to increase demand for convenient tablet forms. Novo Nordisk's CEO, Mike Doustdar, stated the company plans to launch Wegovy in Germany soon at its chosen price, despite pressure from the U.S. administration to increase prices in Europe. The U.K. is the only country to have agreed to higher medicine prices through a bilateral deal with the U.S.

    Foundayo's initial availability in the U.K. will be in the private market, with the NICE decision pending for NHS coverage.

    Frequently asked questions

    Foundayo is an oral weight-loss pill developed by Eli Lilly, belonging to the GLP-1 drug class, approved for weight management and type 2 diabetes.

    Regulatory decisions for Foundayo in the EU are not expected until next year.

    A decision on NHS coverage by the National Institute for Health and Care Excellence is expected by November 18.

    This is the first European regulatory approval for Eli Lilly's oral GLP-1 drug, marking a potential shift in the weight-loss medication market.

    What Happens Next

    01NICE to decide on NHS coverage for Foundayo by November 18.
    02Foundayo expected to launch in the EU next year.

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    Cadence

    How It Developed

    The UK's MHRA approved Eli Lilly's weight-loss pill Foundayo.
    Foundayo is the first oral GLP-1 drug approved in Europe.
    EU access to Foundayo is not expected until next year.
    The National Institute for Health and Care Excellence will decide on NHS coverage by November 18.
    Novo Nordisk plans to launch its GLP-1 pill Wegovy in Germany soon.

    Sources

    T1
    UK approves its second weight-loss pill while EU access lagsPOLITICO Europe

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