BAM Clinic in Joliet not affected by FDA revoking emergency use authorization of bamlanivimab when used alone

On April 16, the U.S. Food and Drug Administration revoked its emergency use authorization of bamlanivimab when the drug is used alone.

Scientific data has emerged that bamlanivimab, an investigational monoclonal antibody therapy to treat mild to moderate COVID-19 in adults and certain pediatric patients, is not as effective against COVID-19 variants, with the risks outweighing its benefits, the FDA said in an April 16 news release.

However, bamlanivimab and etesevimab, when given together, still are authorized for emergency use by the FDA, according to the April 16 news release.

The decision does not affect treatment at the Bam Clinic located at AMITA Health Saint Joseph Medical Center in Joliet.

“Our pharmacists were aware of the revocation of the EUA for bamlanivimab alone and have already converted treatment to the combination recognized and still endorsed by the FDA,” said Timothy Nelson, spokesperson for AMITA Health Saint Joseph Medical Center. “The alternative monoclonal antibody therapies that remain available under EUA are now being used at all AMITA Health clinics.”

AMITA Health Saint Joseph Medical Center began offering infusions of only bamlanivimab Jan. 25 for patients with mild to moderate COVID-19, according to a Feb. 11 Herald-News story.

Dr. Dan Garganera, a board-certified infectious-disease specialist, had said at the time that St. Joe’s had hoped to make the combination drug available soon, which it did in March.

“All our bamlanivimab clinics began offering only the combination treatments still under EUA on March 26 after receiving notification the approval for sole use of bamlanivimab was ceasing,” Nelson said. “There was no interruption of service during the transition.”

The FDA had issued the emergency use authorization on Feb. 9 for the co-administration of bamlanivimab and etesevimab.

From Nov. 9 to March 2, 32,490 total doses of bamlanivimab had been shipped to Illinois, according to the U.S. Department of Health and Human Services.