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Few Pandemic Treatment Tools on Tap: Covid Therapies Explained

Feb. 5, 2021, 3:19 PM

Former President Donald Trump got an antibody Covid-19 treatment and an antiviral drug, but those therapies continue to be underused throughout the U.S.

The U.S. government wants the antibody products from Regeneron Pharmaceuticals Inc. and Eli Lilly and Co. to be prescribed more often, but it isn’t happening. Last month the administration allocated enough of them for 641,000 patients and noted only 25% of what was available was being used.

1. What treatments are available for Covid-19 patients?

Several products are authorized by the FDA to treat Covid-19 directly, but their usefulness varies based on the severity of the disease in the patient.

Antibody treatments are made up of lab-produced proteins that mimic the immune system’s ability to fight off viruses. The Food and Drug Administration authorized two antibody treatments last year—one from Eli Lilly called bamlanivimab and a therapeutic cocktail from Regeneron, casirivimab/imdevimab.

Gilead Sciences Inc.'s antiviral drug remdesivir, sold under the brand name Veklury, is an antiviral drug that was earlier tested for treating hepatitis C and Ebola. It can be combined with Eli Lilly’s arthritis drug Olumiant for severe Covid-19 patients.

The FDA also approved the use of convalescent plasma—blood from patients who have survived Covid-19—to treat other patients.

Finally, health providers use the common generic steroid dexamethasone to treat severe Covid-19 patients, though it isn’t authorized by the FDA specifically to treat the coronavirus.

2. Which treatments work best?

Different products are used for Covid-19 patients at varying stages of severity.

Veklury or remdesivir is intended for patients who are hospitalized with severe Covid-19 symptoms, like those who are on a ventilator. The addition of Eli Lilly’s arthritis drug is also meant for hospitalized patients on ventilators.

Dexamethasone also is typically only used for people with severe symptoms. If used too early, it can do more harm than good. A large study conducted in the U.K. showed dexamethasone reduced up to one-third of deaths for people hospitalized for Covid-19.

Convalescent plasma can be used for hospitalized patients who don’t require supplemental oxygen. The FDA recently restricted its authorization just to plasma with high levels of Covid-19 antibodies, saying “Plasma with low levels of antibodies has not been shown to be helpful in COVID-19.” The FDA also said the treatment should only be used for patients in the early course of the disease and those who can’t produce enough of their own antibodies to fight the disease.

Antibody treatments are meant for people with mild to moderate symptoms, generally those who don’t go to the hospital. Janet Woodcock, a longtime drug chief at the FDA and who headed Trump’s Operation Warp Speed therapeutic program, says there’s enough data to show the products work, but an influential infectious diseases group advised not to use them routinely to treat Covid-19.

3. Why aren’t more hospitals giving antibody treatments?

Antibody treatments are administered through an intravenous infusion, which requires trained personnel to step away from their usual duties to administer them. Health providers are already swamped and say they can’t spare the manpower, especially when some doctors aren’t convinced the treatments work enough to justify the effort.

Patients also need to get antibodies before their symptoms get severe enough to require hospitalization. People are reluctant to go to the hospital if they only have mild symptoms.

Some hospitals also report reimbursement issues. Although the government paid for the antibodies that have been allocated already, there’s been a delay in reimbursement for administering the product. One hospital leader reported it was $100,000 in the hole while waiting for payment paperwork to go through.

4. What about the antiviral remdesivir?

Some doctors argue there isn’t strong enough data to justify full FDA approval for Veklury. The FDA fully approved Veklury in October primarily based on a clinical trial sponsored by the National Institute of Allergy and Infectious Diseases that showed the drug sped up recovery time. However, results from a larger World Health Organization trial showed Veklury “had little or no effect on overall mortality, initiation of ventilation and duration of hospital stay in hospitalized patients.”

5. Are there other Covid-specific medicines in development?

There are hundreds of Covid-19 treatments in development, and the FDA has a Coronavirus Treatment Acceleration Program specifically to speed up authorizations for them. Still, development for new therapeutics has slowed down as scientists and regulators have shifted their focus to evaluating vaccines. Duplicative and poorly run trials for Covid-19 treatments are also clogging up the clinical trial pipeline and sucking up precious resources.

From Bloomberg Law:
Pushed to Give Covid Therapy, Health Centers Await Medicare Cash

Clinical Trial Sites Compete for Covid-19 Patients, Study Staff

Gilead’s Covid Drug Win Could Clog Pipeline for Other Treatments (1)

New Lilly, Regeneron Covid-19 Antibody Center Set Up in Tucson

Underused Covid Therapy Gets Boost in Nursing Homes From HHS

From Bloomberg News:
U.S. Officials Plead for More Use of Languishing Antibody Drugs

Regeneron, Lilly Reveal Positive Results for Antibody Combos (2)

Lilly Antibody Combo Therapy Reduced Viral Levels in Study (1)

A Trump-Touted Covid Therapy Awaits Proof to Back Up His Boasts

To contact the reporter on this story: Jacquie Lee in Washington at jlee1@bloomberglaw.com

To contact the editors responsible for this story: Fawn Johnson at fjohnson@bloombergindustry.com; Alexis Kramer at akramer@bloomberglaw.com

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