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Noom says its program aligns with FDA regulations

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Novo Nordisk says illegal to make semaglutide copies

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Doses can start at half the size of the typical regimen

By Amina Niasse

NEW YORK, May 20 (Reuters) - Online weight-loss company

Noom has begun offering smaller doses of compounded versions of

Novo Nordisk's Wegovy as the U.S. drugs regulator

clamps down on mass production of copies of the in-demand

medicine.

Noom will offer its version of compounded semaglutide - the

active ingredient in Wegovy and diabetes drug Ozempic - as part

of a program personalized for patients, which it says will

comply with changing U.S. Food and Drug Administration

regulations.

Demand for the new generation of highly effective but pricey

weight-loss drugs has catapulted sales at Noom and rival

telehealth sites including Hims & Hers, WeightWatchers

and Ro over the past two years.

Taking small doses of the weight-loss drugs, sometimes

referred to as micro-dosing, has become popular due to the high

cost and side effects of the medicines.

For hundreds of dollars less than the name brand drugs,

patients could access doctors and pharmacy-made versions based

on semaglutide or tirzepatide, the main ingredient in Eli

Lilly's ( LLY ) rival Zepbound and Mounjaro, due to a regulatory

exception allowing them during drug shortages.

However, the FDA declared the shortages over and its sunset

deadline for compounded versions of Wegovy is May 22.

Noom offers its compounded semaglutide at a starting price

of $149 for the first month. A 2.5 milligram vial of Wegovy or

Zepbound costs $349, according to Novo and Lilly websites.

Analysts have said the telehealth companies must pivot to

working with branded drugs in order to survive after

WeightWatchers filed for bankruptcy.

Jeffrey Egler, Noom's chief medical officer, said providers

would determine if patients need a smaller dose because of

concerns about gastrointestinal side effects, or to boost

adherence or help keep lost weight off, for example.

Noom CEO Geoff Cook said the move would not conflict with

regulations. "There is a personalized, and there has always been

a personalized, exception," Cook said.

Novo Nordisk said it is illegal to make or sell semaglutide

copies in the U.S. with only rare exceptions.

"As the FDA has warned, compounders cannot evade federal

compounding laws by selling knockoff semaglutide drugs with

manipulated, unnecessary, and pretextual changes to doses and

ingredients," a Novo Nordisk spokesperson said in a statement.

DOSING

Noom's documents show that a personalized approach could

start with half the typical starter 0.25-milligram dose of

Wegovy and gradually increase to about half the FDA-approved

maximum dose of 2.4 mg over 20 weeks.

Noom said the move is not meant to capitalize on the

microdosing trend, saying patients could increase their dose to

the target, just more slowly.

Noom said it will continue selling branded Novo Nordisk

drugs as well as Lilly's Zepbound.

Clinical trials of Wegovy and Zepbound have shown the drugs

can lead to reductions of 15% to 20% of a person's body weight.

A recent study suggests that half the usual dose of

semaglutide may be as effective a weight-loss tool as current

dosing.

While compounders can create copies for individuals of doses

not available in branded drugs, ongoing FDA reviews of whether

tirzepatide and semaglutide fall into a category of drugs too

complex to qualify for any compounding could put an end to the

practice, said Rosalie Hoyle, a research scientist at Avalere.

"As it stands today, compounders still can technically make

a personalized dose of semaglutide and tirzepatide," she said.