The FDA has approved Epclusa (Gilead), a fixed-dose combination of sofosbuvir (Sovaldi) and velpatasvir, a new direct-acting antiviral agent, for oral treatment of chronic hepatitis C virus (HCV) infection. Epclusa is the first oral combination to be approved for treatment of all six major HCV genotypes.

The FDA has approved the subcutaneously injected interleukin (IL)-4 receptor alpha antagonist dupilumab (Dupixent – Sanofi/Regeneron) for treatment of eosinophilic esophagitis (EoE) in patients ≥12 years old who weigh ≥40 kg and treatment of prurigo nodularis in adults. Dupilumab is the first drug to be approved in the US for each of these indications. It is also FDA-approved for treatment of atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyposis.

Since the introduction of fluoxetine (Prozac - Medical Letter, 30:45, 1988), bupropion (Wellbutrin - Medical Letter, 31:97, 1989), sertraline (Zoloft - Medical Letter, 34:47, 1992) and paroxetine (Paxil - this issue), the choice of an antidepressant has become more difficult. Should these widely prescribed new drugs replace tricyclic antidepressants such as amitriptyline (Elavil, and others), imipramine (Tofranil, and others), or nortriptyline (Aventyl, and others) for treatment of most patients with depression?

Use of a proton pump inhibitor (PPI) to protect against gastrointestinal (GI) bleeding in patients taking the antiplatelet agent clopidogrel (Plavix) may interfere with the activation of clopidogrel and diminish its antiplatelet effect, increasing the risk of cardiovascular events.1 A randomized, placebo-controlled trial (COGENT) has found that use of the PPI omeprazole in patients taking clopidogrel in addition to aspirin decreased the incidence of GI bleeding without increasing the risk of a cardiovascular event, but the number of cardiovascular events was small and the formulation of...

Felodipine (Plendil - Merck), an extended-release preparation of a dihydropyridine calcium-channel blocker was recently marketed in the USA for oral treatment of hypertension. An immediate-release formulation is available in some other countries.

Cannabis (marijuana) contains more than 60 pharmacologically active cannabinoids; delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) are the best known. THC is the main psychoactive constituent of cannabis. CBD, unlike THC, does not produce intoxication or euphoria.

The FDA has approved ocrelizumab (Ocrevus – Genentech), a humanized anti-CD20 monoclonal antibody, for treatment of adults with primary progressive or relapsing multiple sclerosis (MS). It is the first anti-CD20 monoclonal antibody to be approved for treatment of MS and the first disease-modifying drug to be approved in the US for primary progressive MS.

The FDA has approved ozanimod (Zeposia – Celgene), a sphingosine 1-phosphate (S1P) receptor modulator, for 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). It is the third oral S1P receptor modulator to be approved in the US for treatment of relapsing forms of MS; siponimod (Mayzent) is also indicated for use in adults, and fingolimod (Gilenya) is approved for use in patients ≥10 years old.

A new fixed-dose tablet (PrandiMet - Novo Nordisk) combining metformin (Glucophage, and others) and repaglinide (Prandin) has been approved by the FDA for treatment of type 2 diabetes in patients already taking both metformin and repaglinide, or for patients not adequately controlled on either drug alone.

An oral formulation of the glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide (Rybelsus – Novo Nordisk) has been approved by the FDA for once-daily treatment of type 2 diabetes in adults. Semaglutide, which has been available in a subcutaneously-injected formulation (Ozempic) since 2017, is the first GLP-1 receptor agonist to become available for oral administration; the 4 other GLP-1 receptor agonists currently available in the US are administered by subcutaneous (SC) injection.