Digital health company Noom has launched a compound pharmacy-made version of Novo Nordisk's obesity drug semaglutide to make the drug more accessible to consumers in the US.
The bold move has been accompanied by a full-page ad in the Wall Street Journal explaining its reasoning, and claiming that the prices of GLP-1 drugs for weight loss are five times too high and need to be brought in line with levels in other countries.
Compounded versions of drugs can be made available to people in the US under regulations that facilitate access to drugs that are in short supply. That means compounded versions of semaglutide – the active ingredient in Novo Nordisk's Ozempic and Rybelsus for diabetes and obesity therapy Wegovy – are already in the market.
While Novo Nordisk and rival obesity therapy manufacturer Eli Lilly are starting to overcome the production constraints that – coupled with massive demand – have resulted in shortages, Noom's WSJ ad calls for US policymakers to keep the status in place "until GLP-1s cost the same in NYC and London."
The FDA has received adverse event reports involving patients who have used them and has taken action against some compounders making versions available based on salt forms of the drug that are unapproved, including semaglutide sodium and semaglutide acetate, so the availability of compounded forms has become controversial.
Noom is best known for its eponymous app that helps people become healthier and lose weight by making changes to their diet and behaviours, and executive chair and former CEO Saeju Jeong said the move into providing semaglutide is "in line with our mission to help everyone everywhere live better longer."
The company is offering compounded semaglutide for $149 for the first month and $279 for subsequent months, pairing the supply of the drug to its digital health platform to create a system that can achieve "sustainable, long-term weight loss" and help people eventually taper off treatment whilst keeping the weight off, said Jeong in a LinkedIn post.
That pricing compares with a cost that can reach $1,000 a month for people without health insurance, according to the company. Other companies bundling compounded semaglutide and digital health programmes for weight loss include Hims & Hers, Sesame, and Ro.
Novo Nordisk previously claimed to have been alarmed by "reports of medical spas, weight loss clinics, pharmacies, and other companies" selling compounded semaglutide to patients on the grounds that they "do not have the same safety, quality, and effectiveness assurances as Novo Nordisk's FDA-approved drugs." Compounding pharmacies are mostly regulated at the state level by boards of pharmacy.
The drugmaker has already taken legal action against some businesses selling compounded semaglutide in a way that does not comply with the FDA's regulations.
The price of GLP-1 drugs has attracted the scrutiny of lawmakers, and Novo Nordisk's chief executive Lars Fruergaard Jørgensen has agreed to appear at a Senate hearing next week to defend the pricing of the group's semaglutide-based therapies.
The Senate Health, Education, Labor and Pensions (HELP) committee launched an investigation into the prices of Ozempic and Wegovy in April.
https://pharmaphorum.com/news/noom-offers-cut-price-compounded-glp-1-drug-obesity
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