FDA Moves To Block Compounded Versions Of Popular Weight-Loss Drugs – NVO, LLY Stocks Gain

• Semaglutide, the key ingredient in Novo Nordisk’s Wegovy and Ozempic, and Tirzepatide, sold by Eli Lilly as Zepbound and Mounjaro, would be excluded from bulk compounding.
• The 503B Bulk List features drug ingredients considered medically necessary, allowing approved outsourcing facilities to use them to make compounded medicines.
• The agency said there is insufficient evidence to justify broader access to compounded versions.

The U.S. Food and Drug Administration, on Thursday, issued a proposal to exclude several popular weight-loss and diabetes drugs from its 503B bulks list, limiting how they can be compounded by outsourcing facilities.

Semaglutide, the key ingredient in Novo Nordisk’s (NVO) Wegovy and Ozempic, and Tirzepatide, sold by Eli Lilly (LLY) as Zepbound and Mounjaro, would be excluded from bulk compounding. The Liraglutide.

FDA Sees No Clinical Need For Compounding Weight Loss Drugs

The 503B Bulk List is an FDA-approved list of drug ingredients considered medically necessary, allowing approved outsourcing facilities to use them to make compounded medicines. In most cases, facilities can only compound drugs from bulk ingredients if they appear on this list or if the drug is officially in shortage.

After reviewing available data, the FDA said it found no clear clinical need to allow compounding of these drugs from raw ingredients. The agency added that its decision is based on patient safety and medical necessity, noting that there is insufficient evidence to justify broader access to compounded versions.

“When FDA-approved drugs are available, outsourcing facilities cannot lawfully compound using bulk drug substances unless there is a clear clinical need,” said FDA Commissioner Marty Makary.

FDA’s Concerns With Compounded Weight Loss Drugs

The agency has been vocal about its issue with compounded weight-loss drugs. In February, the FDA said it intends to tighten rules around GLP-1 ingredients used in compounded medicines, citing concerns about quality, safety, and possible legal issues. Compounded drugs are not reviewed or approved by the FDA.

The agency added that compounded GLP-1 drugs should be used only when a patient’s needs cannot be met by an approved treatment. It also flagged risks such as improper storage, dosing mistakes, and counterfeit or misleadingly marketed products.

Earlier this year, Novo Nordisk sued Hims & Hers (HIMS) for patent infringement after HIMS launched a $49-per-month compounded version of Wegovy, claiming it used the same active ingredient as the branded drug. However, the two companies later reconciled, teaming up to offer FDA-approved versions of Wegovy and Ozempic at more affordable self-pay prices on the telehealth platform.

Meanwhile, shares of LLY and NVO gained 9% and 5%, respectively, while HIMS edged 0.5% lower and Teladoc Health (TDOC) fell 2%.

Read also: LLY Stock Up 7% Pre-Market As Mounjaro, Zepbound Sales Smash Expectations – Retail Bets On Run Toward $1,000

For updates and corrections, email newsroom[at]stocktwits[dot]com.