Vedolizumab (Entyvio; Takeda), an integrin receptor antagonist, was found to be superior to adalimumab (Humira; AbbVie), a tumor necrosis factor-alpha (TNFα) antagonist, in achieving clinical remission in patients with moderately to severely active ulcerative colitis (UC), according to results from a phase 3b head-to-head trial.
The Food and Drug Administration (FDA) has approved updated labeling for Farxiga (dapagliflozin; AstraZeneca) and Xigduo XR (dapagliflozin and metformin HCl extended-release; AstraZeneca) to expand the use of these products in type 2 diabetes patients with moderate renal impairment.
The Food and Drug Administration has accepted for review the New Drug Application for a novel oral fumarate candidate, diroximel fumarate (Alkermes and Biogen), for the treatment of relapsing forms of multiple sclerosis.
According to data from on an ongoing postmarketing safety trial conducted by Pfizer, tofacitinib dosed at 10mg twice daily was associated with an increased risk of pulmonary embolism and overall mortality in patients with rheumatoid arthritis (RA).
The Food and Drug Administration has approved Lonsurf ((trifluridine and tipiracil; Taiho Oncology) for the treatment of adult patients with metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma previously treated with at least 2 prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy.
The Food and Drug Administration (FDA) has approved Lotemax SM (loteprednol etabonate ophthalmic gel) 0.38% for the treatment of postoperative inflammation and pain following ocular surgery.
Results from a placebo-controlled study evaluating Chantix (varenicline; Pfizer) in pediatric patients 12-16 years of age showed that the smoking cessation treatment was not associated with a significant increase in abstinence rates in this patient population.
The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Soliris (eculizumab; Alexion) for use in patients with neuromyelitis optica spectrum disorder (NMSOD), a complement-mediated disorder of the central nervous system.
The prescribing information for Uloric (febuxostat; Takeda) is being updated to include a Boxed Warning regarding an increased risk of cardiovascular (CV) death and all-cause mortality in patients treated with the gout drug.
In older patients with inflammatory bowel disease (IBD), tumor necrosis factor alpha antagonist (anti-TNF) therapy and vedolizumab (an integrin receptor antagonist) were found to be comparable with regard to both safety and effectiveness, according to a study published in Alimentary Pharmacology & Therapeutics.
