On August 23, 2020, COVID-19 Convalescent Plasma was issued a EUA by the FDA.
On October 22, 2020, the FDA approved the antiviral drug Veklury (remdesivir) to treat patients with COVID-19 requiring hospitalization.
On November 9, 2020, the FDA issued emergency authorization for Eli Lilly's investigational monoclonal antibody therapy Bamlanivimab to treat mild-to-moderate COVID-19 in adult and pediatric patients. This EUA has been modified by the U.S. FDA, issuing an additional EUA on February 9, 2021, for bamlanivimab and etesevimab administered together to treat mild to moderate COVID-19 in certain patients. On April 16, 2021, Lilly requested the withdraw of the single-use EUA.
On November 21, 2020, the FDA authorized REGEN-COV (casirivimab and imdevimab) to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients 12 years of age or older weighing at least 88 pounds) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19. This emergency authorization includes 65 years of age or older or certain chronic medical conditions.
On December 23, 2020, Merck announced it has entered into an agreement with the U.S. Government to support the development, manufacture, and initial distribution of an investigational biological therapeutic (CD24Fc, to be named MK-7110) upon approval or Emergency Use Authorization from the U.S. FDA. Merck acquired MK-7110 through the acquisition of New Jersey-based OncoImmune.
On March 5, 2021, based on the REMAP-CAP and RECOVERY trials' collective evidence, the COVID-19 Treatment Guidelines Panel published updated Recommendations for Actemra (Tocilizumab), an anti-inflammatory drug used to treat rheumatoid arthritis, has been reported to improve severely ill COVID-19 patients' outcomes.
On May 26, 2021, the FDA issued an emergency use authorization for the investigational monoclonal antibody therapy Sotrovimab for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 88 pounds with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progression to severe COVID-19.
Late-Stage Experimental COVID-19 Therapies
Olumiant (baricitinib), an oral JAK1/JAK2 inhibitor, is evaluated in a phase 3 study in hospitalized adults with COVID-19 disease.
According to the RECOVERY trial, dexamethasone (glucocorticoid) reduced deaths in hospitalized patients with severe COVID-19 disease by one-third compared to those receiving usual care.
Aviptadil (RLF-100) is a formulation of synthetic human Vasoactive Intestinal Peptide, which targets the VPAC1 receptor of the ATII cell and protects that cell against all manner of injuries, including smoke inhalation, exposure to stomach acid, and exposure to infectious agents. The U.S. FDA granted Expanded Access Protocol to RLF-100 (Aviptadil) for Respiratory Failure in COVID-19.
Tradipitant may accelerate clinical improvement in hospitalized COVID-19 pneumonia patients reported in a phase 3 study. Tradipitant is an experimental drug that is a neurokinin 1 antagonist. It works by blocking substance P, a small signaling molecule.
NRx Pharmaceuticals announced on June 1, 2021, it had applied with U.S. FDA requesting a EUA for ZYESAMI™ (Aviptadil-acetate) to treat Critically Ill COVID-19 patients suffering from respiratory failure.
Early-Stage Experimental COVID-19 Therapies
Molnupiravir (MK-4482/EIDD-2801) is an oral antiviral medication originally developed to treat influenza. MK-4482/EIDD-2801 consists of the nucleoside analog N4-hydroxycytidine. Molnupiravir has been evaluated against coronaviruses, suppressing virus transmission within 24-hours.
CytoDyn's Leronlimab is intended to serve as a therapy for patients who experience respiratory illness due to COVID-19.
AstraZeneca's AZD7442 long-acting antibody combination (LAAB) is launching late-stage clinical studies in various countries. Combining two LAABs is also designed to reduce the risk of resistance developed by the SARS-CoV-2 virus.
Roche and Atea's AT-527 has demonstrated clinical safety/tolerability and potent antiviral efficacy in patients with HCV infection, as well as a favorable human pharmacokinetic profile, with potent in vitro activity against human coronaviruses.
Pfizer Inc. is evaluating an investigational, novel oral antiviral clinical candidate PF-07321332, a SARS-CoV2-3CL protease inhibitor, which has demonstrated potent in vitro anti-viral activity against SARS-CoV-2, as well as activity against other coronaviruses, suggesting potential for use in the treatment of COVID-19 as well as potential use to address future coronavirus threats.
Previous COVID-19 and SARS-CoV-2 Treatment News are found on this CoronavirusToday webpage.
Note: This content was last reviewed by health care professionals, such as Dr. Robert Carlson.