The FDA has approved nusinersen (Spinraza – Biogen) for treatment of spinal muscular atrophy (SMA), a hereditary neurodegenerative disease that occurs in about one in every 10,000 births. It is the first drug to be approved in the US for this indication.

The FDA has approved avelumab (Bavencio – EMD Serono) and durvalumab (Imfinzi – AstraZeneca), two new immune check point inhibitors, and pembrolizumab (Keytruda – Merck), a checkpoint inhibitor that has been available in the US since 2014, for treatment of locally advanced or metastatic bladder cancer. Nivolumab (Opdivo) and atezolizumab (Tecentriq) were approved earlier for this indication.

The FDA has approved donislecel-jujn (Lantidra – CellTrans), an allogeneic pancreatic islet cellular therapy, for use in conjunction with immunosuppression for treatment of adults with type 1 diabetes who are unable to approach target HbA1c because of current repeated episodes of severe hypoglycemia despite intensive diabetes management and education. Donislecel is the first cell-based treatment to be approved in the US for type 1 diabetes.

The FDA has approved the subcutaneously injected interleukin (IL)-4 receptor alpha antagonist dupilumab (Dupixent – Sanofi/Regeneron) for add-on maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. Dupilumab is the first biologic drug to be approved in the US for this indication. It has been available for years for treatment of asthma, atopic dermatitis, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, and prurigo nodularis.

The FDA has warned that use of an SGLT2 (sodium-glucose co-transporter 2) inhibitor for treatment of type 2 diabetes may lead to ketoacidosis.1 Three SGLT2 inhibitors, canagliflozin (Invokana, Invokamet), dapagliflozin (Farxiga, Xigduo XR), and empagliflozin (Jardiance, Glyxambi), are approved for treatment of type 2 diabetes in the US. Between March 2013 and June 2014, 20 cases of ketoacidosis requiring emergency room visits or hospitalization were reported in patients who had recently started taking an SGLT2 inhibitor; the median time to onset of symptoms after initiation of therapy was 2...

View Figure 2: Pneumococcal Vaccine Recommendations for Adults ≥65 Years Old

Use of screening tests to identify cancers before they cause symptoms can lead to earlier therapy and may improve outcomes. Screening tests for some common cancers are reviewed below.

This issue includes reviews of drugs for glaucoma, age-related macular degeneration (AMD), bacterial conjunctivitis, and dry eye disease. Allergic conjunctivitis is reviewed in a separate issue.

The FDA has approved the Bruton tyrosine kinase (BTK) inhibitor acalabrutinib (Calquence – AstraZeneca) for oral treatment of relapsed or refractory mantle cell lymphoma. Acalabrutinib is the second BTK inhibitor to be approved for this indication; ibrutinib (Imbruvica) was approved in 2013.Ibrutinib inhibits other kinases in addition to BTK and has been associated with severe adverse effects, particularly atrial fibrillation, infection, rash, and bleeding, that may be related to inhibition of kinases other than BTK.1 Acalabrutinib is a more selective BTK inhibitor than ibrutinib; whether...

On July 12, 2021, the FDA added a warning to the Fact Sheet for the Johnson & Johnson (Janssen) adenovirus-based COVID-19 vaccine about an increased risk of Guillain-Barré syndrome (GBS) following administration of the product.