Companies push for emergency use of monoclonal antibody therapy, drug given to President Trump

ByDan Ashley and Tim Didion KGO logo
Saturday, October 10, 2020
Drug given to president may get emergency approval
Regeneron, the company that makes a monoclonal antibody given to the president just announced that it will ask for an Emergency Use Authorization.

SAN FRANCISCO (KGO) -- President Donald Trump's treatment for COVID-19 may have touched off a race to get similar medications to market.

Regeneron, the company that makes a monoclonal antibody which was given to the president, just announced that it will ask for an Emergency Use Authorization, even though it hasn't finished the clinical trial. That comes just days after Eli Lilly said it would make the same EUA request for its antibody treatment.

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"That might have had something to do with it, but they would have been doing this soon anyway, and I think it's a matter of the two companies trying to decide who's going to get the leg up on the other," said Dr. Yvonne Maldonado, M.D.

Dr. Maldonado is involved with a clinical trial of Regeneron at Stanford. First, it's important to understand that monoclonal antibodies are basically an engineered version of the COIVD-19 fighting antibodies produced by our immune systems. Dr. Maldonado says they're well understood, but still require testing.

"Granted, we know monoclonals work well and they're pretty safe, but we just have to make sure with this new pathogen," she says.

With strong support from the Trump administration, the FDA has already issued several EUA's, including one for the drug hydroxychloroquine that was later reversed.

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Still, there is interest in the antibodies as more than just a treatment, but possibly as a short-term substitute for a vaccine, that could knock down the virus for several weeks or months.

"Scenarios, where it might be quite dangerous for someone to get the coronavirus, having short term protection, might be quite useful," Dr. Annie Luetkemeyer of UCSF believes.

Dr. Luetkemeyer is involved with a trial of the Eli Lilly drug. She sees a need to strike an effective balance, with speed and safety.

"It's great that this is promising, and we all want to get life-saving therapy to people, we just need to make sure we complete the work we set out to do," she says.

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The ultimate authority to grant Emergency Use Authorizations rests with Alex Azar, head of Health and Human Services, and a former executive at Eli Lilly. Both Bay Area researchers say transparency is critical.

"I would say if there were some interests in there, that other people need to weigh in as well besides he, although he is the ultimate decision-maker," says Dr. Maldonado.

For his part, Azar has promised in the past to ignore politics and base all decisions on the science.

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