FDA yanks EUA for Lilly’s bebtelovimab COVID-19 antibody

The FDA has pulled the emergency use authorization (EUA) for bebtelovimab, the monoclonal antibody from Eli Lilly (NYSE:LLY), because it no longer adequately protects against the BQ.1 and BQ.1.1 omicron subvariants.

In late November, the BQ.1 variant was responsible for 27.9% of U.S. COVID-19 infections, according to CDC. The BQ.1.1 variant represented 29.4% of infections. Meanwhile, the BA.5 variant made up 19.4% of infections. The BQ.1 and BQ.1.1 variants are likely to grow even more prevalent in the coming weeks.

FDA authorized bebtelovimab in February, which remained effective against the original omicron variant.

Bebtelovimab was the last monoclonal antibody to have an EUA. However, FDA has suspended its authorizations of several other such antibodies during the pandemic with the rise of COVID-19 variants that elude them.

An FDA Health Care Provider Fact Sheet stated that several variants, including the omicron subvariants BQ.1 and BQ.1.1, were associated with a significant reduction in susceptibility to bebtelovimab. For example, the BA.1 and BQ.1.1 variants showed a more than 672-fold decrease in susceptibility to the antibody.

Lilly and its distributors have paused the distribution of bebtelovimab for the time being.

LLY shares were mostly flat, trading at $370.74 in mid-day trading.

FDA recommends alternative therapies to individuals diagnosed with COVID-19, including Pfizer’s Paxlovid for high-risk individuals 12 and older who weigh at least 40 kg.

The agency has approved Veklury (remdesivir) from Gilead Sciences (Nasdaq:GILD) for individuals not hospitalized with mild-to-moderate COVID-19. The approval of the drug covers high-risk individuals at least 28 days of age.

The agency also recommended Lagevrio (molnupiravir) from Merck & Co. (NYSE:MRK) and Ridgeback Biotherapeutics for high-risk individuals infected with COVID-19.

In addition, the agency has also authorized convalescent plasma with high levels of anti-SARS-CoV-2 antibodies for patients with immunosuppressive disease and those on immunosuppressants.

Finally, FDA recommends full vaccination for eligible individuals, including the updated bivalent vaccines, which it authorized in late August.

In unrelated news, LLY’s share price have recovered after dipping after a fake Twitter profile made a bogus insulin announcement.