Eli Lilly and Company (NYSE:LLY) cleared a notable regulatory hurdle on August 10, when Britain's drug regulator authorized the company's oral GLP-1 drug orforglipron, becoming the first country in Europe to approve the pill. Shares of LLY increased more than 2% in response to the announcement, a modest but insightful reaction for a company whose weight-loss franchise has become the single most important driver of its market value.
The UK's Medicines and Healthcare Products Regulatory Agency approved orforglipron, offered under the brand name Foundayo, for weight loss and maintenance in obese adults, as well as select overweight individuals with at least one weight-related health condition. The approval also addresses increasing blood sugar control in people with type 2 diabetes.
What sets Foundayo apart from Lilly's other weight-loss medications, as well as the majority of the GLP-1 category in general, is the format. Unlike injectable drugs like Lilly's Zepbound or Novo Nordisk A/S (NYSE:NVO)'s Ozempic, Foundayo is a small, non-peptide GLP-1 receptor agonist that is taken as a single daily tablet. It can also be taken at any time with no food or water restrictions, making it a far more convenient regimen than some oral peptide alternatives that require fasting windows around dosing.
The clinical data that supports the approval is strong. In the ATTAIN-1 trial, which tracked 3,127 individuals with obesity for 72 weeks, participants on the 36 mg dose lost an average of 11.2% of their body weight, as opposed to 2.1% on placebo, and more than half of those on that dose lost at least 10%.
The authorization is crucial, but it is not the final step. Foundayo is not currently available through the NHS in the UK, and the drug's journey to that larger market is through the National Institute for Health and Care Excellence, which is completing its own cost-effectiveness study, with a decision expected on November 18. Until NICE decides, UK patients seeking the medicine will have to pay out of pocket or get it privately, a scenario that is already playing out with competing products in the category.
#foundayo #loss #NYSE #regulatory
The UK's Medicines and Healthcare Products Regulatory Agency approved orforglipron, offered under the brand name Foundayo, for weight loss and maintenance in obese adults, as well as select overweight individuals with at least one weight-related health condition. The approval also addresses increasing blood sugar control in people with type 2 diabetes.
What sets Foundayo apart from Lilly's other weight-loss medications, as well as the majority of the GLP-1 category in general, is the format. Unlike injectable drugs like Lilly's Zepbound or Novo Nordisk A/S (NYSE:NVO)'s Ozempic, Foundayo is a small, non-peptide GLP-1 receptor agonist that is taken as a single daily tablet. It can also be taken at any time with no food or water restrictions, making it a far more convenient regimen than some oral peptide alternatives that require fasting windows around dosing.
The clinical data that supports the approval is strong. In the ATTAIN-1 trial, which tracked 3,127 individuals with obesity for 72 weeks, participants on the 36 mg dose lost an average of 11.2% of their body weight, as opposed to 2.1% on placebo, and more than half of those on that dose lost at least 10%.
The authorization is crucial, but it is not the final step. Foundayo is not currently available through the NHS in the UK, and the drug's journey to that larger market is through the National Institute for Health and Care Excellence, which is completing its own cost-effectiveness study, with a decision expected on November 18. Until NICE decides, UK patients seeking the medicine will have to pay out of pocket or get it privately, a scenario that is already playing out with competing products in the category.
#foundayo #loss #NYSE #regulatory
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