Nerandomilast (Jascayd – Boehringer Ingelheim), an oral phosphodiesterase 4 (PDE4) inhibitor, has been approved by the FDA for treatment of idiopathic pulmonary fibrosis (IPF) in adults. It is the third drug to be approved in the US for this indication; the oral antifibrotic drugs pirfenidone (Esbriet, and generics) and nintedanib (Ofev) were approved in 2014.

The FDA has expanded the licensed use of the recombinant respiratory syncytial virus (RSV) vaccine Arexvy (GSK) to include adults 18-49 years old. Arexvy and the two other available RSV vaccines, Abrysvo and mResvia, are now all licensed for prevention of RSV lower respiratory tract disease in persons ≥60 years old and in those 18-59 years old who are at increased risk of lower respiratory tract disease caused by RSV. Abrysvo is also licensed for use in pregnant women at 32-36 weeks' gestation to prevent RSV-associated lower respiratory tract disease in their infants from birth to...

Relacorilant (Lifyorli – Corcept Therapeutics), an oral first-in-class glucocorticoid receptor antagonist, has been approved by the FDA for use in combination with nab-paclitaxel (Abraxane, and generics) for treatment of platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer in adults who received 1-3 prior lines of systemic therapy, one of which included bevacizumab (Avastin, and others).

Pharmacologic treatment is recommended for postmenopausal women who have bone density T-scores (standard deviations from normal mean values in the spine, femoral neck, total hip, or distal radius) of -2.5 or below, T-scores between -1.0 and -2.5 with a history of fragility (low-trauma) fracture of the hip or spine, or T-scores between -1.0 and -2.5 with a FRAX 10-year probability of ≥3% for hip fracture or ≥20% for major osteoporotic fracture.

The FDA has approved changes to the wording of the cardiovascular risk reduction indications for the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors evolocumab (Repatha) and alirocumab (Praluent). Both drugs are now approved to reduce the risk of major adverse cardiovascular events (MACE) in adults at increased risk for these events; they were previously approved to reduce the risk of MACE only in patients with established cardiovascular disease (CVD).

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.

In our article on Drugs for Chronic Insomnia, we said there is little evidence that antidepressants such as trazodone, mirtazapine, or amitriptyline are effective in treating insomnia not associated with depression. We received a comment from a reader who has prescribed the tricyclic antidepressant amitriptyline for insomnia, particularly for patients with headache disorders, and finds that most patients are satisfied with the treatment.

Ocrevus Zunovo (Genentech), a subcutaneous (SC) formulation of the anti-CD20 monoclonal antibody ocrelizumab plus human recombinant hyaluronidase-ocsq has been approved by the FDA for treatment of primary progressive and relapsing forms of multiple sclerosis (MS). Intravenous ocrelizumab (Ocrevus), which was approved for the same indications in 2017, is one of the most commonly prescribed drugs for treatment of MS. Ocrelizumab remains the only drug approved for treatment of primary progressive MS.

Optune Pax (Novocure), a portable device that delivers low-intensity alternating electrical fields to the abdomen, has been approved by the FDA for use with gemcitabine and nab-paclitaxel (GnP) for treatment of locally advanced pancreatic cancer in adults. It is the first device to be approved in the US for treatment of pancreatic cancer. Similar devices are available for treatment of certain lung cancers (Optune Lua) and glioblastoma (Optune Gio).

The oral Janus kinase (JAK) inhibitor baricitinib (Olumiant – Lilly), which was previously approved by the FDA for treatment of moderately to severely active rheumatoid arthritis and treatment of COVID-19 in certain hospitalized adults, has now been approved for treatment of severe alopecia areata in adults. Baricitinib is the first systemic treatment to be approved in the US for this indication.