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The Medical Letter on Drugs and Therapeutics • April 5, 2021 (Issue 1621)
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...
The Medical Letter on Drugs and Therapeutics • April 5, 2021 (Issue 1621)
The once-monthly, subcutaneously injected calcitonin gene-related peptide (CGRP) receptor antagonist erenumab-aooe (Aimovig) was approved by the FDA in 2018 for preventive treatment of migraine in adults. Now the FDA has added a new warning to its labeling about a risk of new-onset hypertension and worsening of preexisting hypertension associated with use of the drug. CGRP is a potent...
The Medical Letter on Drugs and Therapeutics • April 5, 2021 (Issue 1621)
View the COVID-19 Vaccine Comparison Chart
The Medical Letter on Drugs and Therapeutics • March 26, 2021 (Issue )
The oral fixed-dose combination of the neprilysin inhibitor sacubitril and the angiotensin receptor blocker (ARB) valsartan (Entresto – Novartis) was approved in 2015 to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction (HFrEF; LVEF <40%). The FDA has now expanded its...
The Medical Letter on Drugs and Therapeutics • March 22, 2021 (Issue 1620)
On February 27, 2021, the FDA issued an Emergency Use Authorization (EUA) for the Johnson...
The Medical Letter on Drugs and Therapeutics • January 25, 2021 (Issue 1616)
On December 18, 2020, the FDA issued an Emergency Use Authorization (EUA) for the Moderna mRNA-based vaccine for prevention of COVID-19 in persons ≥18 years old. The Pfizer-BioNTech mRNA-based vaccine received an FDA EUA for the same indication in persons ≥16 years old on December 11, 2020.
The Medical Letter on Drugs and Therapeutics • January 11, 2021 (Issue 1615)
A transdermal formulation of the second-generation (atypical) antipsychotic asenapine (Secuado – Noven) has been approved by the FDA for once-daily treatment of schizophrenia in adults. Asenapine is the first antipsychotic to become available in a transdermal formulation in the US. A twice-daily sublingual tablet formulation of asenapine (Saphris) has been available since 2009....
The Medical Letter on Drugs and Therapeutics • January 11, 2021 (Issue 1615)
The FDA has issued an Emergency Use Authorization (EUA) for the Pfizer-BioNTech mRNA-based vaccine for prevention of COVID-19 in persons ≥16 years old.
The Medical Letter on Drugs and Therapeutics • December 28, 2020 (Issue 1614)
The FDA has issued an Emergency Use Authorization (EUA) for Regeneron's investigational monoclonal antibodies casirivimab (REGN10933) and imdevimab (REGN10987) to be administered together by IV infusion 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 (see...
The Medical Letter on Drugs and Therapeutics • December 28, 2020 (Issue 1614)
The oral Janus kinase (JAK) inhibitor baricitinib (Olumiant – Lilly) has been granted an FDA Emergency Use Authorization (EUA) for treatment of confirmed or suspected COVID-19 in hospitalized patients ≥2 years old who require supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO); the EUA requires that baricitinib be used in combination with the IV...
The Medical Letter on Drugs and Therapeutics • December 3, 2020 (Issue )
The FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) will review two requests for Emergency Use Authorization (EUA) of COVID-19 vaccine candidates this month. They will review Pfizer and BioNTech's request on December 10 and Moderna's request on December 17. Both meetings will be webcast from the FDA's website and streamed on Facebook, Twitter, and YouTube.
The Medical Letter on Drugs and Therapeutics • November 30, 2020 (Issue 1612)
The FDA has approved the antiviral drug remdesivir (Veklury – Gilead) for IV treatment of COVID-19 in hospitalized patients who are ≥12 years old and weigh ≥40 kg. Hospitalized children who are <12 years old or weigh <40 kg can receive remdesivir through an Emergency Use Authorization (EUA). Remdesivir is the first drug to be approved in the US for treatment of COVID-19.
The Medical Letter on Drugs and Therapeutics • November 30, 2020 (Issue 1612)
The Advisory Committee on Immunization Practices (ACIP) has issued new recommendations for meningococcal vaccination. Booster vaccination against Neisseria meningitidis serogroup B (MenB) is now recommended in persons at increased risk for meningococcal disease (see Table 1). MenB booster doses were not recommended previously for any population.
The Medical Letter on Drugs and Therapeutics • November 30, 2020 (Issue 1612)
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).
The Medical Letter on Drugs and Therapeutics • November 16, 2020 (Issue 1611)
The FDA has required the addition of information about an increased risk of nonmelanoma skin cancer (basal cell carcinoma [BCC] and squamous cell carcinoma [SCC]) to the labels of products containing the diuretic hydrochlorothiazide.
The Medical Letter on Drugs and Therapeutics • November 16, 2020 (Issue 1611)
View the Comparison Chart: SGLT2 Inhibitors
The Medical Letter on Drugs and Therapeutics • November 2, 2020 (Issue 1610)
Influenza is generally a self-limited illness, but complications such as pneumonia, respiratory failure, and death can occur, especially in patients at increased risk for influenza complications (see Table 1). Antiviral drugs recommended for treatment and chemoprophylaxis of influenza this season are listed in Table 2. Updated information on influenza activity and antiviral resistance is...
The Medical Letter on Drugs and Therapeutics • November 2, 2020 (Issue 1610)
An oral extended-release formulation of the corticosteroid budesonide (Ortikos – Ferring) is now available for once-daily treatment of mild to moderate active Crohn's disease of the ileum and/or ascending colon in patients ≥8 years old and for maintenance of remission for up to 3 months in adults. Ortikos is the second oral formulation of budesonide to be approved for this...
The Medical Letter on Drugs and Therapeutics • November 2, 2020 (Issue 1610)
The FDA now requires boxed warnings in the package inserts of benzodiazepines describing the potential for these drugs to be abused and misused and to cause addiction and physical dependence. Benzodiazepine labels have contained a boxed warning about a risk of serious drug interactions with opioids since 2016.
The Medical Letter on Drugs and Therapeutics • November 2, 2020 (Issue 1610)
The FDA has required a new warning in the labels of prescription and over-the-counter products containing nonsteroidal anti-inflammatory drugs (NSAIDs) advising against their use during pregnancy beginning at 20 weeks’ gestation because of a risk of renal dysfunction in the fetus that could lead to low amniotic fluid levels (oligohydramnios) and neonatal renal impairment. NSAID labels previously...