Article Content

Second biosimilar of adalimumab now available

Adalimumab-adbm (Cyltezo), the second biosimilar version of AbbVie's reference tumor necrosis factor (TNF) blocker adalimumab (Humira), has been approved by the FDA for the treatment of adults with moderately to severely active rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, moderately to severely active Crohn disease, moderately to severely active ulcerative colitis, and moderate-to-severe plaque psoriasis. It is also approved for treatment of children age 4 years or older with moderately to severely active polyarticular juvenile idiopathic arthritis.


Adalimumab-adbm is administered by subcutaneous injection. The FDA notes that adalimumab-adbm has demonstrated it is highly similar to the already approved reference product adalimumab and has shown it has no clinically meaningful differences in terms of safety and effectiveness from the reference product.


The most serious known adverse reactions associated with adalimumab-adbm are infections and malignancies. As with reference adalimumab, adalimumab-adbm has a boxed warning regarding the increased risk for serious and sometimes fatal infections, and the warning also cautions that lymphoma and other (sometimes fatal) malignancies have occurred in children and adolescents treated with TNF inhibitors, including adalimumab products.


FDA approves new antibacterial drug for complicated urinary tract infections

The FDA has approved meropenem and vaborbactam (Vabomere) for adults with complicated urinary tract infections (cUTIs), including pyelonephritis caused by susceptible bacteria Escherichia coli, Klebsiella pneumoniae, and Enterobacter cloacae species complex. Meropenem and vaborbactam inhibit certain types of bacterial resistance mechanisms. The new drug is administered via I.V. infusion over 3 hours, and treatment duration can last up to 14 days. Dosage adjustments, based on the estimated glomerular filtration rate, are needed for patients with kidney impairment.

Figure. No caption a... - Click to enlarge in new windowFigure. No caption available.

The FDA approved the drug based on a clinical trial of safety and efficacy conducted in 545 adults with cUTIs, including those with pyelonephritis. Approximately 7 days after completing treatment, almost 77% of patients treated with meropenem and vaborbactam had resolved symptoms and a negative urine culture (as compared with approximately 73% of patients treated with piperacillin and tazobactam).


Meropenem and vaborbactam should only be used to treat or prevent infections that are confirmed or strongly suspected to be caused by susceptible bacteria to reduce the development of drug-resistant bacteria and to maintain the effectiveness of antibacterial drugs.


The most common adverse reactions are headache, infusion site reactions, and diarrhea. The drug is associated with serious risks, including allergic reactions and seizures. It is contraindicated in patients with a history of anaphylaxis to beta-lactams.


New indication for liraglutide

The FDA has approved a new indication for liraglutide (Victoza) for reducing the risk of myocardial infarction (MI), stroke, and cardiovascular death in adults with type 2 diabetes mellitus (T2DM) who have established cardiovascular disease. Liraglutide was originally approved to improve glycemic control in patients with T2DM and is the only T2DM treatment indicated to reduce the risk of three major adverse cardiovascular events. It is a subcutaneous injection for adults with T2DM and is not for use in patients with type 1 diabetes mellitus or patients with diabetic ketoacidosis.

Figure. No caption a... - Click to enlarge in new windowFigure. No caption available.

The additional cardiovascular events indication was approved based on the results of the FDA-mandated Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results (LEADER) trials. The LEADER trials showed that liraglutide reduced the risk of the composite endpoint of cardiovascular death, nonfatal MI, and nonfatal stroke by 13% compared with placebo (P = .01), with an absolute risk reduction of 1.9%.