The investigational oral antiviral drug molnupiravir (Merck/Ridgeback Biotherapeutics) was granted an FDA Emergency Use Authorization (EUA) on December 23, 2021 for treatment of mild to moderate COVID-19 in outpatients ≥18 years old who are at high risk of progressing to severe disease, including hospitalization or death (see Table 1), and for whom alternative treatment options are not available or clinically appropriate. Paxlovid (Pfizer), nirmatrelvir copackaged with ritonavir, was granted an EUA on December 22, 2021. The IV antiviral drug remdesivir (Veklury) was approved by the...

On December 22, 2021, the FDA issued an Emergency Use Authorization (EUA) for the investigational antiviral drug nirmatrelvir copackaged with the HIV-1 protease inhibitor ritonavir (Paxlovid – Pfizer) for oral treatment of mild to moderate COVID-19 in outpatients ≥12 years old who weigh at least 40 kg and are at high risk of progressing to severe disease, including hospitalization or death. Paxlovid was the first oral antiviral drug to be authorized in the US for treatment of COVID-19; Merck's oral antiviral drug molnupiravir was granted an EUA for treatment of COVID-19 on...

In February 2021, the FDA issued an Emergency Use Authorization (EUA) for the investigational monoclonal antibodies bamlanivimab and etesevimab (Lilly) for use together to treat mild to moderate COVID-19 in persons ≥12 years old who weigh ≥40 kg and are at high risk of progression to severe disease or hospitalization. The FDA has now expanded this EUA to allow use of the antibodies together for post-exposure prophylaxis of COVID-19 in such persons if they are not fully vaccinated against COVID-19 or are unlikely to have an adequate immune response to full vaccination and have...

The FDA has approved Roxybond (Daiichi Sankyo), an short-acting (SA) oxycodone formulation with abuse-deterrent properties, for treatment of pain requiring management with an opioid. Roxybond is the first SA opioid to be approved as an abuse-deterrent product. Oxaydo, another IR oxycodone formulation, has properties that discourage its intranasal and intravenous use, but is not considered an abuse-deterrent product by the FDA. Use of opioids for treatment of pain was reviewed in a recent issue.

The FDA has issued an Emergency Use Authorization (EUA) for Regeneron's investigational monoclonal antibodies casirivimab and imdevimab (REGEN-COV) to be administered together by IV infusion or SC injection for treatment of mild to moderate COVID-19 in adults and pediatric patients (≥12 years old and weigh ≥40 kg) who are at high risk of progressing to severe COVID-19 and/or hospitalization.

The FDA has issued an Emergency Use Authorization (EUA) for Lilly's investigational monoclonal antibodies bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016) to be administered together for treatment of mild to moderate COVID-19 in patients ≥12 years old who weigh ≥40 kg and are at high risk of progressing to severe disease and/or hospitalization (see Table 1). Bamlanivimab received an EUA for use as monotherapy in such patients in November 2020. Regeneron's investigational monoclonal antibodies casirivimab (REGN10933) and imdevimab (REGN10987) are also authorized for use...

The investigational monoclonal antibody bebtelovimab (LY-CoV1404 – Lilly) has been granted an FDA Emergency Use Authorization (EUA) for IV treatment of mild to moderate COVID-19 in patients ≥12 years old who weigh ≥40 kg and are at high risk of progressing to severe disease, including hospitalization and death, and for whom alternative treatment options are unavailable or inappropriate. Bebtelovimab is active against the Omicron variant of SARS-CoV-2; sotrovimab (VIR-7831) is the only other monoclonal antibody currently available for treatment of COVID-19 that is active...

Three products are currently available in the US for treatment of high-risk,1 nonhospitalized adults with mild to moderate COVID-19: oral ritonavir-boosted nirmatrelvir (Paxlovid), IV remdesivir (Veklury), and oral molnupiravir (Lagevrio). Remdesivir is FDA-approved for such use; nirmatrelvir/ritonavir and molnupiravir are available under an FDA Emergency Use Authorization. Because the pivotal clinical trials of these products for outpatient use were conducted in patients who were not vaccinated against COVID-19, some clinicians have questioned whether they can benefit vaccinated...

The FDA has approved the over-the-counter (OTC) sale of Narcan (Emergent), a nasal spray that delivers 4 mg of the opioid antagonist naloxone. Narcan nasal spray has been available by prescription since 2015 for emergency treatment of opioid overdose. Generic formulations of Narcan have also been approved; the manufacturers of these products will be required to switch them to OTC status and amend their labeling accordingly. Kloxxado, an 8-mg naloxone nasal spray, remains available only by prescription.

Eculizumab (Soliris - Alexion) has been approved by the FDA for reduction of hemolysis in patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare form of hemolytic anemia. A recombinant humanized monoclonal antibody, eculizumab is the first drug to be marketed for this indication.