New approvals

Azilsartan medoxomil (Edarbi) tablets have been approved by the Food and Drug Administration (FDA) for treating hypertension.1 Compared with olmesartan and valsartan, the 80-mg dose had greater 24-hour blood pressure-lowering effects, in Phase 3 clinical trials.2 It is available in 40-mg and 80-mg tablets. In addition, a new drug application (NDA) was recently filed for a tablet that combines both azilsartan and chlorthalidone. In a clinical trial presented at the American Society of Hypertension's 2010 meeting, the combination of azilsartan/chlorthalidone had better blood pressure-lowering effects than the combination of azilsartan and hydrochlorothiazide (HCTZ).

After all this waiting, belimumab (Benlysta) was finally FDA-approved for treating systemic lupus erythematosus (SLE) in March 2011.3 It is a monoclonal antibody that targets B-lymphocyte stimulator protein, also known as BLyS. It is dosed via an intravenous (IV) infusion of 10 mg/kg every 2 weeks for three doses, followed by every 4-week dosing thereafter. Patients in clinical trials only had modest improvement in symptoms with the agent, but its effectiveness was significantly better than placebo. One-year response rates were 43% for belimumab-treated patients and 32% for placebo-treated patients. The drug should not be administered along with live vaccines. A medication guide will be distributed to all patients who receive this agent to inform them of the treatment risks. The last agent to be FDA-approved to treat SLE was hydroxychloroquine, in 1955.

At a recent guideline committee meeting of the American College of Cardiology, the American Heart Association, and the Heart Rhythm Society, the committee recommended that dabigatran be used as an alternative to warfarin in patients with atrial fibrillation who do not have significant heart valve disease, do not have a prosthetic heart valve, and/or do not have advanced hepatic disease, and/or do not have severe renal failure to reduce their clot risk.6 Other similar agents are currently in the FDA pipeline for this and other similar uses.7

The QMS Everolimus Immunoassay was recently FDA-approved as the first test to monitor everolimus blood levels in renal transplant patients.8 Similar blood level tests are already available to monitor transplant patients receiving cyclosporine, tacrolimus, and/or sirolimus. The test is manufactured by Thermo Fisher Scientific (Waltham, Mass.).

Voriconazole tablets were FDA-approved as a generic of Vfend in February of 2011.9 The company has 180 days of market exclusivity before other generics will be available. The liquid and IV versions of the drug are covered under a separate patent.

Calcitonin, recombinant salmon oral, is currently in Phase 3 clinical trials for the treatment of postmenopausal osteoporosis.10 It was compared with synthetic salmon calcitonin nasal spray and placebo in 565 women, in a Phase 3 clinical trial. At 1 year, the recombinant oral calcitonin product was statistically significantly non-inferior to placebo and nasal calcitonin in increasing bone mineral density.

CTAP101 is currently in Phase 2b clinical trials.11 It is an oral, non-hormonal, treatment for vitamin D insufficiency in patients with secondary hyperparathyroidism and stage 3 chronic kidney disease (CKD). It is currently undergoing clinical trials to evaluate its efficacy, safety, pharmacokinetics, pharmacodynamics, and tolerability.

Dapagliflozin has had its NDA accepted by the FDA and the European Medicines Agency (EMA) as a new antidiabetic agent in a potentially new medication class.12 The new class is that of sodium-glucose co-transporter-2 (SGLT2) inhibitors, which target a specific location in the kidney, controlling glycemia independent of insulin pathways.12 Presently, there is limited information on using this agent in patients with renal disease. The FDA's Prescription Drug User Fee Act (PDUFA) goal date for this agent is October 28, 2011.

Exenatide extended-release (Bydureon) failed to reduce average blood glucose levels in type 2 diabetics compared with liraglutide in a Phase 3 head-to-head trial known as DURATION-6.13 The fate of this agent is not yet known. The FDA declined its approval in October 2010, requesting additional data on its effect on heart rates. It is expected that Eli Lilly/Amylin will respond to the FDA's letter in the second half of this year.

Lixisenatide, a once-daily glucagon-like peptide-1 (GLP-1) agonist, was shown to be as effective as twice daily exenatide in lowering HbA1c levels from baseline in type 2 diabetic patients in the 24-week GetGoal-X trial.14, 15 Additionally, lixisenatide-treated patients exhibited fewer symptomatic hypoglycemic reactions compared with exenatide-treated patients (2.5% vs. 7.9%, p < 0.05), and sixfold fewer hypoglycemic events were observed with the investigational agent compared with the FDA-approved agent (8 vs. 48 events). Patients received stepwise dose increases up to a maximum of 20 µm.