FDA顾问窄幅支持四种肽类复方配制，Hims & Hers商业机会仍未落地

A majority of the U.S. FDA's outside advisers on Thursday supported allowing pharmacies to compound the first four of seven peptides under review, ‌advancing efforts championed by Health Secretary Robert F. Kennedy Jr. to expand access to the increasingly popular compounds.

The two-day meeting is pitting the FDA staff against a telehealth industry anxious to tap into what analysts estimate could quickly become a $2 billion to $3 billion market if legitimized. The staff has advised against allowing for broader pharmacy compounding of the seven peptides, saying there is scant evidence to support their safety and effectiveness.

Injectable versions of peptides, ​drugs built from the same building blocks the body uses to make proteins, are already being sold widely online for everything from muscle recovery to longevity through a ​gray market that relies on allowable use of unapproved medicines for research purposes.

The panel has been asked to decide if each of the ⁠seven peptides should be designated by the FDA as being allowed to be compounded by pharmacies for patients with a prescription. The Biden administration in 2023 found that nearly 20 peptides ​raised safety concerns and barred their legal compounding.

In a narrow majority, eight of the members voted in favor to add the unapproved peptides BPC-157, KPV and TB-500. Six members voted against while ​one member abstained.

It was a 7-5 vote in favor for MOTs-C, which is being evaluated for obesity and osteoporosis. Two members abstained.

Many of the panelists who voted yes have ties to the peptide industry.

"All committee members underwent the same ethics review and vetting process required of all FDA advisory committee members," said Emily Hilliard, a Department of Health and Human Services spokesperson, adding candidates that could not meet existing ethics requirements were ​removed from consideration.

The 14-member committee prior to the meeting added seven people who operate or work for clinics or businesses selling peptide treatments.

Many members who voted in favor could stand to ​gain from allowing BPC-157 for compounding, said Paul Knoepfler, a professor of cell biology at UC Davis: "How is that acceptable?"

Advisers backing broader access argued that patients face safety risks when obtaining these products from ‌the unregulated or ⁠gray market.

On the other hand, those who voted against were doctors and patient representatives.

"I'm concerned that we're responding to a market-induced demand rather than a decision based in solid science," said Elizabeth Rebello, a panel member and professor at the University of Texas.

The advisers will convene on Friday to vote on three more additional peptides. The FDA is not bound by the panel's recommendations.

Shares of telehealth firm Hims & Hers (HIMS.N) - which spoke in favor of peptides at the meeting - closed the day 3.3% higher at $32.74. Analysts said the positive vote signaled regulatory support for the company's plans to offer the products.

FDA ​URGES CLINICAL TRIALS

There are many peptides, such ​as insulin and GLP-1 drugs, that have ⁠been approved by the health regulator. The ones being evaluated in the meeting have not gone through such clinical trials, and are being easily purchased online, without any doctor supervision.

Matt Lash, an FDA official, in the meeting on Thursday said the compounded products have not been approved ​by the FDA and added that compounded products are not required to have labels that notify patients of any safety or doses.

Another official, ​Russell Wesdyk, encouraged the ⁠industry to pursue FDA investigational new drug applications and to conduct trials in humans to evaluate the substances.

The FDA's staff reviewers had last month in documents advised the panel that the agency should not move in favor of permitting state-licensed compounding pharmacies to do so.

In April, Kennedy reclassified 12 of them as Category 1 substances, the first regulatory step toward adding them to be compounded by pharmacies.

BPC-157, ⁠TB-500 IN FOCUS

Among ​the peptides being discussed on Thursday, BPC-157 and TB-500 have become increasingly popular and the combination is popularly known ​as the "Wolverine stack". It is purported to aid muscle growth and injury recovery.

Industry players said a clear backing of compounding will help build the sector for interested consumers.

Hims' Chief Medical Officer Anant Vinjamoori told the panel the company stands to ​benefit commercially if BPC-157 were added to the list.