Berotralstat (Orladeyo – Biocryst), an oral plasma kallikrein inhibitor, has been approved by the FDA for prevention of hereditary angioedema (HAE) attacks in adults and children ≥12 years old. The subcutaneously-injected plasma kallikrein inhibitor lanadelumab-flyo (Takhzyro) and the human plasma-derived C1 esterase inhibitors (C1INHs) Cinryze, which is given IV, and Haegarda, which is given SC, have been available for prophylaxis of HAE for years.

The FDA has amended its Emergency Use Authorization (EUA) for the investigational long-acting monoclonal antibodies tixagevimab and cilgavimab (Evusheld – AstraZeneca) to recommend repeat dosing every 6 months in patients who require ongoing protection against COVID-19. Evusheld is authorized for IM pre-exposure prophylaxis of COVID-19 in persons ≥12 years old who weigh ≥40 kg and have either a history of a severe adverse reaction that prevents their vaccination against COVID-19 or moderate or severe immune compromise

The FDA has warned that the investigational long-acting monoclonal antibodies tixagevimab and cilgavimab (Evusheld – AstraZeneca) are unlikely to neutralize the XBB.1.5 Omicron variant of SARS-CoV-2. Evusheld is available under an Emergency Use Authorization (EUA) for IM pre-exposure prophylaxis of COVID-19 in persons ≥12 years old who weigh ≥40 kg and have either a history of a severe adverse reaction that prevents their vaccination against COVID-19 or moderate or severe immune compromise.

Lyme disease in the US is caused by the spirochete Borrelia burgdorferi, which is transmitted to humans by Ixodes scapularis (blacklegged [deer] tick) and I. pacificus (western blacklegged tick). Most cases of Lyme disease occur in late spring and early summer in northeastern and mid-Atlantic states, the upper Midwest, and in northern California. B. mayonii, which is also transmitted by I. scapularis, has been shown to cause a similar illness in the upper Midwest.

The FDA has approved lanadelumab-flyo (Takhzyro – Takeda), a subcutaneously-administered plasma kallikrein inhibitor, for prevention of hereditary angioedema (HAE) attacks in adults and children ≥12 years old. Lanadelumab is the third drug to be approved for this indication; the human plasmaderived C1 esterase inhibitors (C1INHs) Cinryze, which is administered IV, and Haegarda, which is given SC, have been available for years for HAE prophylaxis in patients ≥6 years old.

Valoctocogene roxaparvovec-rvox (Roctavian – Biomarin), an adeno-associated virus (AAV) vector-based gene therapy, has been approved by the FDA for one-time treatment of severe hemophilia A in adults without pre-existing antibodies to AAV serotype 5. It is the first gene therapy to be approved in the US for treatment of hemophilia A.

An outbreak of monkeypox has recently spread around the globe and across the US. Updated information about the current outbreak is available from the CDC.

Drugs for gout are used to reduce the pain and inflammation of acute flares, decrease the frequency of exacerbations, and lower serum urate levels to prevent recurrent flares, development of tophi, and joint damage.

The labeling for the investigational, long-acting, prophylactic anti-SARS-CoV-2 monoclonal antibodies tixagevimab and cilgavimab (Evusheld; available under an FDA Emergency Use Authorization) now includes warnings about a risk of serious hypersensitivity reactions, including anaphylaxis, with use of the drugs, particularly in patients who have experienced a hypersensitivity reaction to a COVID-19 vaccine.

The CDC has issued new guidance allowing for an interval of up to 8 weeks between the first and second primary doses of an mRNA COVID-19 vaccine in certain patients 12-64 years old.1 Product labeling currently recommends a 3-week interval between the first two doses of the Pfizer/BioNTech mRNA vaccine (Comirnaty) and a 4-week interval between the first two doses of the Moderna mRNA vaccine (Spikevax). The new guidance is based on data suggesting that a longer interval can decrease the risk of myocarditis and may improve vaccine efficacy.