Dasatinib (Sprycel - Bristol-Myers Squibb), an inhibitor of multiple tyrosine kinases, has been approved by the FDA for second-line treatment of chronic myelogenous leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in adults.

Duetact (Takeda), a new fixed-dose combination of the thiazolidinedione pioglitazone (Actos) and the sulfonylurea glimepiride (Amaryl, and others), was recently approved by the FDA for treatment of type 2 diabetes. It is approved as an adjunct to diet and exercise to improve glycemic control in patients already taking pioglitazone and/or a sulfonylurea. Avandaryl, a combination of glimepiride and the thiazolidinedione rosiglitazone, was approved in 2006.

The FDA has approved the nucleoside analog telbivudine (Tyzeka - Novartis/Idenix) for treatment of patients ≥16 years old with active chronic hepatitis B virus (HBV) infection. It is the fourth oral drug marketed for this indication in the US.

Changes caused by one drug in the absorption, distribution, metabolism or excretion of another may lead to a pharmacokinetic adverse drug interaction (DN Juurlink et al, JAMA 2003; 289:1652). Additive drug interactions, such as vasodilation caused by both sildenafil (Viagra) and nitrates, can also have adverse effects.

Atazanavir (Reyataz - Bristol-Myers Squibb), a new protease inhibitor (PI), and emtricitabine (Emtriva - Gilead), a nucleoside analogue reverse transcriptase inhibitor (NRTI) chemically similar to lamivudine, have been approved by the FDA for treatment of HIV-1 infection. Both are taken once daily, unlike most anti-HIV drugs.

The FDA has approved Odefsey (Gilead), a once-daily, fixed-dose combination of the non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine and the nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection in patients with HIV-1 RNA (viral load) ≤100,000 copies/mL or to replace a stable antiretroviral regimen in patients who have been virologically suppressed (viral load <50 copies/mL) for at least six months with no history of treatment failure.

The FDA has approved Epclusa (Gilead), a fixed-dose combination of sofosbuvir (Sovaldi) and velpatasvir, a new direct-acting antiviral agent, for oral treatment of chronic hepatitis C virus (HCV) infection. Epclusa is the first oral combination to be approved for treatment of all six major HCV genotypes.

The FDA has approved the subcutaneously injected interleukin (IL)-4 receptor alpha antagonist dupilumab (Dupixent – Sanofi/Regeneron) for treatment of eosinophilic esophagitis (EoE) in patients ≥12 years old who weigh ≥40 kg and treatment of prurigo nodularis in adults. Dupilumab is the first drug to be approved in the US for each of these indications. It is also FDA-approved for treatment of atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyposis.

Standard approaches to therapy for gastroesophageal reflux disease (GERD) include lifestyle changes, over-the-counter and prescription drugs, and sometimes surgery. Emerging endoscopic anti-reflux procedures that are less invasive than surgery are potential additions to current treatment options. An endoscopicallyguided radiofrequency (RF) energy delivery system, Stretta (Curon Medical), was approved by the FDA for treatment of GERD in 2000.

A variety of glucose monitoring devices have been used in an effort to reduce the hypoglycemia and wide glucose excursions that complicate insulin treatment of diabetes. Since the last Medical Letter issue reviewing such devices, more continuous glucose monitoring (CGM) systems have become available. Five devices available now, and two expected to be marketed soon, are listed in the table on page 14. The FDA has approved continuous glucose devices only for the observation of glucose trends.