The FDA has approved a higher-dose injectable formulation of the opioid antagonist naloxone (Zimhi – Adamis) for emergency treatment of opioid overdose. A single IM or SC injection of the new formulation delivers 5 mg of naloxone; injectable formulations that deliver 0.4 mg or 2 mg of the drug have been available for years. Naloxone is also available in intranasal formulations for the same indication (see Table 1).

The investigational anti-complement component 5a (C5a) antibody vilobelimab (Gohibic – InflaRx) has been granted an FDA Emergency Use Authorization (EUA) for IV treatment of hospitalized adults with COVID-19 beginning within 48 hours after invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO) is started. Vilobelimab is the first anti-C5a antibody to become available in the US.

The injectable glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide (Wegovy) has been approved by the FDA to reduce the risk of major adverse cardiovascular events (MACE) in adults with established cardiovascular disease (CVD) and either obesity or overweight. Semaglutide is the first drug to be approved for cardiovascular risk reduction in this population. It is also approved in a lower-dose injectable formulation as Ozempic and in an oral formulation as Rybelsus (see Table 1).

View the Table: GLP-1 and GIP/GLP-1 Receptor Agonists for Type 2 Diabetes

The investigational neutralizing IgG1 monoclonal antibody bamlanivimab (LY-CoV555; Lilly) has been granted an FDA Emergency Use Authorization (EUA) for treatment of recently diagnosed mild to moderate COVID-19 in patients who are ≥12 years old, weigh at least 40 kg, and are at high risk for progressing to severe disease and/or hospitalization (see Table 1).

Odevixibat (Bylvay – Albireo), an oral ileal bile acid transporter (IBAT) inhibitor, has been approved by the FDA for treatment of pruritus in patients ≥3 months old with progressive familial intrahepatic cholestasis (PFIC). It is the first drug to be approved in the US for this indication.

The FDA has approved a generic injectable formulation of the opioid antagonist nalmefene (Purdue) for the management of known or suspected opioid overdose. Revex, the reference product, was withdrawn from the market in 2008 for commercial reasons.

An oral nonopioid analgesic is often sufficient for acute treatment of mild to moderate migraine pain without severe nausea or vomiting. A triptan is the drug of choice for treatment of moderate to severe migraine in most patients without vascular disease. Treatment of pain when it is still mild to moderate in intensity improves headache response and reduces the risk of recurrence.

Atrial fibrillation (AF) is the most common arrhythmia in the world. Risk factor modification, anticoagulation, rhythm control, and rate control are the four pillars of its management. American College of Cardiology/American Heart Association (ACC/AHA) guidelines on management of AF were updated recently.

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...