The FDA has approved over-the-counter (OTC) sale of the weight-loss drug orlistat (Xenical – Roche)1 as alli (GlaxoSmithKline), to be used in combination with a reduced-calorie, low-fat diet. Orlistat binds to gastric and pancreatic lipases, preventing absorption of about 30% of dietary fat with the 120-mg prescription dose, and 25% with the 60-mg OTC dose. A 16-week controlled trial of the OTC dose (60 mg 3 times daily with meals) in overweight, not obese, patients (average BMI 26.8) on a reduced-calorie, low-fat diet found that patients taking the drug lost 1.15 kg more than those taking...

Modestly elevated C-reactive protein (CRP) concentrations have been associated with an increased risk of coronary heart disease. The recently published and heavily publicized results of the JUPITER trial will lead many patients to ask health care professionals whether they should have a CRP test to see if they should be taking a statin.

The FDA has approved the use of recombinant human antithrombin (rhAT; ATryn - Lundbeck) in patients with inherited antithrombin (AT) deficiency to prevent thrombosis during or after surgery or childbirth. The protein is produced in the milk of transgenic goats carrying a copy of the human cDNA for AT. This is the first US drug approval for a protein produced by a transgenic animal. ATryn has been used in Europe since 2006.

The FDA has approved five tumor necrosis factor (TNF) inhibitors for treatment of moderately to severely active rheumatoid arthritis (RA). TNF-α is a pro-inflammatory cytokine involved in the pathogenesis of many systemic inflammatory disorders.

Misoprostol (Cytotec, and generics), a prostaglandin E₁ analog FDA-approved for prevention of NSAID-induced gastric ulcers and, when taken with mifepristone (Mifeprex), for termination of early intrauterine pregnancy, has also been used off-label for years for medical management of first-trimester spontaneous abortion (miscarriage).

Secukinumab (Cosentyx – Novartis), an injectable human interleukin (IL)-17A antagonist, has been approved by the FDA for treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. It is the first IL-17 inhibitor to be approved for any indication in the US.

The FDA has approved the immune checkpoint inhibitor atezolizumab (Tecentriq – Genentech) for treatment of locally advanced or metastatic urothelial carcinoma and metastatic non-small cell lung cancer (NSCLC) that have progressed during or following platinum-based chemotherapy. Atezolizumab is the first programmed death-ligand 1 (PD-L1) blocking antibody to become available in the US. Two other immune checkpoint inhibitors, the programmed death receptor-1 (PD-1) inhibitors nivolumab (Opdivo) and pembrolizumab (Keytruda), are also approved for treatment of metastatic NSCLC, and...

The FDA has approved dupilumab (Dupixent – Sanofi/Regeneron), a subcutaneously-injected fully human monoclonal antibody, for treatment of adults with moderate to severe atopic dermatitis (eczema) that has not responded to topical therapies. It can be used with or without topical corticosteroids.

The FDA has approved Qtern (AstraZeneca), a fixed-dose combination of the sodium-glucose co-transporter 2 (SGLT2) inhibitor dapagliflozin (Farxiga) and the dipeptidyl peptidase-4 (DPP-4) inhibitor saxagliptin (Onglyza), for oral treatment of adults with type 2 diabetes. Dapagliflozin and saxagliptin have each been available for years alone and in combination with extended-release metformin (Xigduo XR; Kombiglyze XR). Three SGLT2/DPP-4 inhibitor combinations are now available in the US (see Table 2).

The FDA has approved prabotulinumtoxinA-xvfs (Jeuveau – Evolus) for temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity. Jeuveau is the fourth botulinum toxin product to be approved in the US for this indication (see Table 1). It has been available in South Korea as Nabota since 2014.