December 20, 2021

COVID-19 Pill Approval and More Updates

Drug manufacturers continue to develop medications to treat COVID-19.  Notably last week, the U.S. Food and Drug Administration (FDA) authorized the first oral therapy for COVID-19, Paxlovid, manufactured by Pfizer. Other medications in development have reached Phase 3 clinical trials. With COVID-19 cases sometimes falling under workers’ comp, it is important to keep track of these developments.

Paxlovid from Pfizer

On December 22nd, the FDA issued an emergency use authorization (EUA) for Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients 12 years or older, with positive results of direct SARS-CoV-2 testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid is available by prescription only and should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset.

Paxlovid is the first oral treatment for COVID-19 authorized by the FDA.

The issuance of an EUA is different than an FDA approval. In determining whether to issue an EUA, the FDA evaluates the totality of scientific evidence available and carefully balances any known or potential risks with any known or potential benefits of the product.

AZD7442 from AstraZeneca

AZD7442 is a combination of two long-acting monoclonal antibodies (tixagevimab and cilgavimab) developed for the prevention of COVID-19. Two multicentered, randomized, double-blind, placebo-controlled trials for intramuscular injections of AZD7442 have yielded positive results so far.

A PROVENT trial with 5,197 unvaccinated participants found that the drug reduced the risk of developing symptomatic COVID-19 by 83% when compared to placebo. Meanwhile, a TACKLE trial was conducted with 903 patients who were non-hospitalized with mild-to-moderate COVID-19 and who were symptomatic for seven days or less. The drug group achieved an 88% risk reduction of developing severe COVID-19 among populations who were symptomatic for three days or less.

Molnupiravir from Merck

An FDA Antimicrobial Drug Advisory Committee voted 13-10 in favor of authorizing the emergency use of Molnupiravir oral capsules, an investigational antiviral, for the treatment of mild-to-moderate COVID-19 for patients at high risk of progressing to severe disease or hospitalization.

A Phase 3 clinical trial with 775 patients found that molnupiravir reduced the risk of hospitalization by 30% when compared to placebo, though it is uncertain how the drug would impact pregnant populations, as pregnant populations were not included in the trial due to concerns over potential embryo-fetal toxicity.

While the FDA is not bound by the committee’s recommendation, they do take their recommendations into consideration when making decisions.

UPDATE: During the publication of this article, the FDA authorized molnupiravir for the treatment of COVID-19 in certain adults. Read more here

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