Allurion Launches Comprehensive GLP-1 Program as FDA Seeks to End Access (Video)

Allurion ( ALUR ) launched a new program to give patients access to combination weight-loss medications on Monday after months of offering its own weight-loss solution — an ingestible balloon — as an alternative for patients who may not want to use the popular injectable GLP. 1 drug.

Allurion CEO Shantanu Gaur told Yahoo Finance that, like others, the company continues to see spillover from unprecedented interest in GLP-1 drugs like Novo Nordisk’s (NVO) Wegovy and Eli Lilly’s (LLY) Zepbound. That’s why the company now offers copycat products at a fraction of the cost.

Allurion’s new program uses artificial intelligence recommendations to help patients eat a balanced diet and exercise in addition to using GLP-1. The AI ​​trainer launched in May and access to semaglutide, a key ingredient in Novo Wegovy, will begin on Monday.

Gaur said the company also has plans to launch tirzepatide, a key ingredient in Lilly’s Zepbound. The FDA recently announced an end to the tirzepatide shortage, putting formulators within a 60-day window to stop production. The FDA allows copycat drugs to be produced if brand-name manufacturers cannot meet demand—which Gaur and others say is still the case despite the FDA’s announcement.

Some compounders have filed suit against the FDA to allow production to continue. The FDA recently delayed a decision on this issue until December 19, while maintaining access to compounded versions of the drug for now. Semaglutide, meanwhile, is under separate FDA review for its place on the agency’s drug shortage list. Novo Nordisk notified the agency that it was able to meet the demand, and the FDA will make a decision after reviewing the company’s data.

Allurion’s decision to join the GLP-1 group at this stage speaks to the continued demand for the drug, despite the fact that it is an ingestible balloon that has similar results to weight loss drugs. The device helps regulate a person’s food intake, resulting in patients losing up to 15% of their body weight in an average of four months.

The cylinder is not yet available in the US, but is approved in other countries. Patients who have tried and failed to lose weight with GLP-1 or are trying to find alternatives have become interested in the balloon, Gaur said.

“Last year, 25% of our balloon patients had previously tried GLP-1,” he said. “This year that number has risen to 33%.”

However, the lack of US approval and continued demand for GLP-1 have put pressure on the company’s shares, which have fallen 96% to under $0.50 per share since the company exited the SPAC and went public in April 2021. The company has been notified of this. meets the requirements to be delisted from the New York Stock Exchange, but Gaur said the company is working toward reinstatement.

When asked if the decision to join the GLP-1 frenzy is an indication of this, Gaur replied: “We have a plan to address the delisting issue. News may help, but the plan does not depend on it.”

The company’s shares fell on news of the announcement on Monday, falling nearly 3% to $0.41 per share.

Anjali Khemlani is a senior healthcare reporter at Yahoo Finance, covering all things pharma, insurance, health services, digital health, PBMs, and health care politics and policy. This, of course, includes GLP-1. Follow Anjali on most social media platforms. @AnjKhem.

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