番茄社区

In what's likely a first for any drug with emergency use authorization (EUA), Regeneron launched TV ads for monoclonal antibody combination therapy for COVID-19.

The ads are , a spokesperson for the FDA's Center for Drug Evaluation and Research told 番茄社区.

"Any materials made available must be consistent with the Letter of Authorization and authorized labeling for the product," the spokesperson said in an email. He noted that FDA has the authority to establish various conditions on the EUA for each product, "including conditions pertaining to advertising and other promotional descriptive printed matter."

Regeneron's EUA for casirivimab/imdevimab specifically states that any promotion must be consistent with authorized labeling. The company can't say that the product is safe or effective in patients with COVID-19, and it must make it clear that the product is authorized, not approved.

While the spokesperson couldn't confirm if this was indeed the very first use of direct-to-consumer advertising for any EUA product in the U.S., it's certainly the first TV ad campaign for any authorized COVID therapy.

The company developed four TV commercials to urge patients to ask their doctors about monoclonal antibodies. , the words "monoclonal antibodies" are repeated several times to help the multisyllabic phrase stick in viewers' memories. In another, seemingly healthy people just diagnosed with COVID are told, "," -- order 2 weeks' worth of groceries, lock yourself in quarantine -- ask your doctor about monoclonal antibodies.

All four ads are available on . The ads direct patients to the consumer-focused site .

Monoclonal antibody combination therapies from Regeneron and Eli Lilly (bamlanivimab/etesevimab) have had a slow uptake in the U.S., largely because they require time at an infusion clinic. The treatment can't be administered in a doctor's office, and not all hospitals have set up such infusion clinics.

In addition, patients need to be well enough to be an outpatient, but at high risk for progressing to severe disease or hospitalization.

There has also been concern about how the treatments work in the face of variants. Eli Lilly's bamlanivimab was originally authorized as a monotherapy, but that was revoked as variants became resistant to the therapy. Additional studies have suggested that the Eli Lilly combination may be less effective against variants, particularly the B.1.351, or South African, variant.

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