The FDA has approved romosozumab-aqqg (Evenity – Amgen), a sclerostin inhibitor, for once-monthly subcutaneous (SC) treatment of osteoporosis in postmenopausal women who are at high risk for fracture (history of osteoporotic fracture or multiple risk factors for fracture) or who have failed or cannot tolerate other drugs for this indication. Romosozumab is the first sclerostin inhibitor to be approved in the US and the third drug for treatment of postmenopausal osteoporosis that stimulates bone formation; the parathyroid hormone (PTH) receptor agonists abaloparatide (Tymlos) and...

The FDA has approved the interleukin (IL)-23 antagonist risankizumab-rzaa (Skyrizi – Abbvie) for treatment of moderate to severe plaque psoriasis in adults. Risankizumab is the third IL-23 antagonist to be approved for this indication; guselkumab (Tremfya) and tildrakizumab (Ilumya) were approved earlier.

The FDA has approved IV amisulpride (Barhemsys – Acacia), a selective dopamine-2 and -3 (D₂/D₃) receptor antagonist, for prevention and treatment of postoperative nausea and vomiting (PONV) in adults. It is the first antiemetic to be approved for rescue treatment of PONV in patients who have symptoms despite receiving antiemetic prophylaxis. Oral formulations of amisulpride are available in Europe for treatment of schizophrenia and acute psychotic episodes.

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.

Since the last Medical Letter review of cephalosporin antibiotics (volume 25, page 57, 1983), many new cephalosporins have become available in the USA.

New guidelines from The National Cholesterol Education Program recommend, as a therapeutic option, lowering treatment goals for LDL cholesterol (LDL-C) from <100 mg/dL to <70 mg/dL for patients at very high risk for coronary heart disease and from 130 mg/dL to <100 mg/dL for those at moderately high risk. A likely consequence of these recommendations is increased use of statins and use of higher doses with a concomitant increase in adverse effects.

Arformoterol tartrate (Brovana - Sepracor), a singleisomer, long-acting beta₂-agonist, has been approved by the FDA as an inhalation solution for nebulization for treatment of bronchoconstriction pulmonary disease (COPD). Arformoterol is the (R,R)-enantiomer of formoterol (Foradil), which is available as a powder for inhalation and was recently also approved as a solution for nebulization (Perforomist - Dey; available fall 2007)

The antiplatelet agents aspirin and clopidogrel (Plavix, and others) are used in most patients undergoing percutaneous coronary intervention (PCI) to prevent stent thrombosis and to reduce the occurrence of peri-, post-procedural and late cardiovascular events. Despite a large number of randomized trials of these agents in such patients, the optimal dosage and duration of treatment with these drugs, and whether other drugs should be added, is unclear.

Saxagliptin (Onglyza - Bristol-Myers Squibb), the second oral dipeptidyl peptidase-4 (DPP-4) inhibitor to be marketed in the US, has been approved by the FDA for treatment of adults with type 2 diabetes.

The oral antimalarial tafenoquine succinate, a long-acting analog of primaquine, has been approved by the FDA in 2 different strengths. Arakoda (100-mg tablets; Sixty Degrees) is indicated for the prophylaxis of malaria in adults. Krintafel (150-mg tablets; GSK) is indicated for the prevention of relapse (radical cure) of Plasmodium vivax malaria in patients ≥16 years old undergoing treatment for acute P. vivax infection.