NEW YORK, May 20 (Reuters) – Online weight-loss company Noom has started offering smaller doses of compounded versions of Wegovy. Wegovy is made by Novo Nordisk and is in high demand. This change comes as the U.S. Food and Drug Administration (FDA) tightens rules on mass production of these copies.
Noom’s compounded semaglutide— the active ingredient in Wegovy and the diabetes drug Ozempic— will be part of a personalized treatment program. The company says this program will follow the new FDA rules.
Demand for these new, highly effective but expensive weight-loss drugs has surged. This has boosted sales at Noom and other telehealth companies like Hims & Hers, WeightWatchers, and Ro over the past two years.
Micro-dosing, or taking small doses of these drugs, has become popular. This is partly due to the high cost and side effects of the medicines.
Patients can get compounded versions of semaglutide or tirzepatide— the main ingredient in Eli Lilly’s drugs Zepbound and Mounjaro— for hundreds of dollars less than the brand-name versions. This has been allowed under a regulatory exception during drug shortages.
However, the FDA has said the drug shortages are over. The deadline to stop making compounded versions of Wegovy is May 22.
Noom offers its compounded semaglutide starting at $149 for the first month. In comparison, a 2.5 milligram vial of Wegovy or Zepbound costs $349, according to Novo Nordisk and Lilly websites.
Analysts say telehealth companies must switch to selling branded drugs to survive, especially after WeightWatchers filed for bankruptcy.
Jeffrey Egler, Noom’s chief medical officer, said doctors will decide if patients need smaller doses. This may be due to concerns about side effects, to help patients stick with treatment, or to maintain weight loss.
Noom CEO Geoff Cook said the new program follows regulations. “There has always been a personalized exception,” he said.
Novo Nordisk disagrees. The company says making or selling copies of semaglutide in the U.S. is illegal, except in rare cases.
A Novo Nordisk spokesperson said, “As the FDA has warned, compounders cannot bypass federal laws by selling knockoff semaglutide drugs with altered doses or ingredients.”
Dosing Approach
Documents from Noom show their personalized program could start at half the usual Wegovy starter dose of 0.25 milligrams. The dose would then slowly increase over 20 weeks to about half of the FDA-approved maximum dose of 2.4 milligrams.
Noom says this approach is not about exploiting the microdosing trend. Patients can still increase their dose to the recommended level, just more gradually.
Noom will also continue selling branded drugs from Novo Nordisk and Lilly’s Zepbound.
Clinical trials have shown Wegovy and Zepbound can reduce body weight by 15% to 20%. A recent study suggests that half the usual dose of semaglutide may work just as well for weight loss.
While compounders can make doses not available in branded drugs, the FDA is reviewing whether tirzepatide and semaglutide are too complex to be compounded at all. This could end the practice, said Rosalie Hoyle, a research scientist at Avalere.
“As of now, compounders can still make personalized doses of semaglutide and tirzepatide,” she said.
