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FDA seeks added safety data from Lilly on newly approved weight-loss pill
PUBLISHED TUE, APR 14 202610:15 AM EDT
Reuters
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LLY
+6.09 (+0.65%)
Eli Lilly Foundayo GLP-1 weight loss pill.
Eli Lilly Foundayo GLP-1 weight loss pill.
Courtesy: Eli Lilly
The U.S. Food and Drug Administration has asked Eli Lilly for more data on liver injury linked to its newly approved obesity pill, according to a letter posted on the health regulator's website.The weight-loss pill, branded Foundayo, won approval earlier this month under the Commissioner's National Priority voucher program, which aims to speed FDA decisions on drugs deemed critical to public health or national security.
The letter, which was signed on April 1, also said that Lilly must conduct post-marketing trials to assess risks of cardiovascular events and delayed gastric emptying.
It also asked the drugmaker to conduct a milk-only lactation study in lactating women who have received a dose of the pill to assess drug concentrations in breast milk using a validated assay.
The drugmaker and the Department of Health and Human Services, which oversees the FDA, did not immediately respond to Reuters requests.
Lilly is already conducting a trial comparing the pill with insulin glargine in participants with type 2 diabetes and obesity who are at increased cardiovascular risk.
The FDA also asked Lilly to run a trial using ultrasound to measure the effects of temporary treatment interruption and fasting duration on retained gastric contents, to evaluate delayed gastric emptying associated with the class of drugs known as GLP-1s.
Lilly began selling Foundayo last week, heating up the battle with Danish rival Novo Nordisk's Wegovy pill, which has been on the market since January.
In trials, Foundayo led to an 11% reduction in body weight over 72 weeks and oral Wegovy led to about a 14% reduction over 64 weeks.
Oral Wegovy must be taken on an empty stomach, with just a sip of water, 30 minutes before any other medications or food and drink, while Lilly's Foundayo can be taken at any time of day without food or water restrictions.
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