The millennial-skewed telehealth platform Hims & Hers (HIMS+0.39%) announced Monday that it will start offering customers a generic version of liraglutide, an older GLP-1 weight loss drug, next year. The news comes as some patients still struggle to fill prescriptions of the most advanced branded GLP-1 treatments on the market like Zepbound, Wegovy and Ozempic.
Hims CEO Andrew Dudum told investors during a call on Monday that company as already "confirmed a core supplier" for its new offering. Liraglutide is currently sold under the brand name Saxenda by Novo Nordisk (NVO-1.19%) and many of its patents have already expired.
In a 56-week-long clinical trial, the once-daily injection helped most patients lose over 5% of their weight. For comparison, patients taking the highest dose of Eli Lilly's (LLY-0.72%) weekly-injectable Zepbound lost over 20% of their weight after 72 weeks during a clinical trial.
Ozempic and prescription weight-loss drugs: How they work, what they cost, side effects, and everything to know
GLP-1 drugs are a class of medications that mimic gut hormones that regulate blood sugar and suppress appetite. Newer versions of these treatments, like Wegovy and Ozempic, have become highly sought after because of their effectiveness at treating obesity and type 2 diabetes. However, due to their high retail price and skyrocketing demand, many patients have had difficulty getting their hands on these popular medications.
When a medication is in shortage, which Eli Lilly's Zepbound and Novo Nordisk's Wegovy have been for most of the year, the Food and Drug Administration (FDA) allows pharmacies to make compounded, or altered, versions of the drug if they meet specific regulatory requirements. This loophole has led several digital health companies, online pharmacies, and wellness spas to produce and sell cheaper versions of brand-name weight loss drugs during recent shortages.
A generic liraglutide offering will provide Hims customers more options as these shortages start to end. The company started selling compounded weight loss drugs this year.
Earlier this month, the FDA marked the shortage of tirzepatide, the active ingredient in Eli Lilly's Zepbound, as resolved. Eli Lilly quickly started sending cease-and-desist letters to companies selling copycat versions.
In response, the Outsourcing Facilities Association filed a lawsuit in Texas against the FDA, challenging its decision to remove tirzepatide from its shortage list and demanding that the move be reversed.
In its lawsuit, obtained by Ars Technica, the group called the FDA's decision "reckless and arbitrary" and argued that it would "deprive patients of a vital treatment for type 2 diabetes and obesity."
In a court filing, the FDA said pharmacists could resume making compounded tirzepatide as it reconsiders its decision to remove the drug from its shortage list.
The FDA also recently updated its drug shortage database to show that the all doses of Novo Nordisk's weight loss and diabetes drugs Wegovy and Ozempic are now available. However, the drugs continue to be considered in shortage for now as the agency and Novo Nordisk work to ensure a steady supply.
Hims chief financial officer Yemi Okupe told Yahoo Finance that company is hearing from customers that they are still finding it difficult to find branded GLP-1s on pharmacy shelves.
"In our view, we do still see that the medications are on shortage," Okupe said. "What consumers are telling us resoundingly is that they are struggling to get access to name-brand GLP-1 medications over the last two months."