Ciclesonide (Omnaris - Sepracor/Nycomed), a once daily corticosteroid nasal spray, is now available for treatment of seasonal allergic rhinitis (SAR) in adults and children ≥6 years old and for perennial allergic rhinitis (PAR) in those ≥12 years old. An orally inhaled formulation of ciclesonide (Alvesco) was recently approved by the FDA for maintenance treatment of asthma, and will be reviewed in a future issue of The Medical Letter

Aliskiren (Tekturna - Novartis), the first direct renin inhibitor for treatment of hypertension, has been approved for use in a fixed-dose combination with the diuretic hydrochlorothiazide (Tekturna HCT - Novartis). Many angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) are also available in fixed-dose combinations with hydrochlorothiazide (HCTZ).

The FDA has approved the marketing of certolizumab pegol (Cimzia - UCB), a tumor necrosis factor (TNF) blocker, for treatment of moderate to severe Crohn's disease refractory to conventional treatment. It is the third TNF blocker approved for this indication.

Two combinations of an inhaled corticosteroid with an inhaled long-acting beta2-agonist are approved by the FDA for use in patients with COPD: fluticasone/salmeterol (Advair Diskus) and budesonide/formoterol (Symbicort). A Medical Letter reader has questioned the safety of using corticosteroid inhalers in patients with this disorder. No single-agent inhaled corticosteroid inhaler is approved for this indication.

The FDA has approved ivabradine (Corlanor – Amgen) to reduce the risk of hospitalization for worsening heart failure in adults with stable, symptomatic chronic heart failure with left ventricular ejection fraction (LVEF) ≤35% who are in sinus rhythm with a resting heart rate ≥70 beats per minute and who are on maximum tolerated doses of beta blockers or have a contraindication to beta blocker use. Ivabradine has been available internationally for years as Procoralan and Corlentor for treatment of stable angina and heart failure.

The injectable glucagon-like peptide-1 (GLP-1) receptor agonist liraglutide, previously approved by the FDA for treatment of type 2 diabetes as Victoza, has now also been approved at a higher dose as Saxenda (Novo Nordisk) for chronic weight management in adults with a BMI ≥30, or a BMI ≥27 with a weight-related comorbidity such as hypertension, dyslipidemia, or diabetes.

The FDA has approved Genvoya (Gilead), a fixed-dose combination of the integrase strand transfer inhibitor (INSTI) elvitegravir, the pharmacokinetic enhancer cobicistat, and the nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) emtricitabine and tenofovir alafenamide, for treatment of HIV-1 infection in patients ≥12 years old. This is the first approval for tenofovir alafenamide (TAF), a tenofovir prodrug. Stribild, a fixed-dose combination of elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate (TDF), was approved in 2012.

The FDA has approved the subcutaneously injected monoclonal antibody dupilumab (Dupixent – Sanofi/Regeneron) for add-on maintenance treatment of patients ≥12 years old with moderate to severe asthma with an eosinophilic phenotype or with oral corticosteroid-dependent asthma. Dupilumab was approved earlier to treat adults with moderate to severe atopic dermatitis inadequately controlled with topical therapies.

On September 22, on the advice of its Vaccines and Related Biologic Products Advisory Committee, the FDA expanded the Emergency Use Authorization (EUA) for the Pfizer/BioNTech mRNA-based COVID-19 vaccine (Comirnaty) to include administration of a booster dose ≥6 months after a 2-dose primary series in adults who are ≥65 years old or at high risk for severe COVID-19 because of an underlying medical condition or frequent institutional or occupational exposure to SARS-CoV-2 (see Table 1). The FDA Advisory Committee recommended against authorization of a booster dose of Comirnaty...

The FDA has approved the recombinant chimeric anti-CD20 antibody ublituximab-xiiy (Briumvi – TG Therapeutics) for IV treatment of adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome (initial neurological episode), relapsing-remitting disease, and active secondary progressive MS (SPMS). Two other anti-CD20 antibodies, IV ocrelizumab (Ocrevus) and SC ofatumumab (Kesimpta), are also FDA-approved for these indications.