Triple-combo tablet for T2DM treatment approved
The FDA approved Trijardy XR (empagliflozin/linagliptin/metformin HCl extended-release) tablets for once-daily therapy in adults with type 2 diabetes mellitus (T2DM), along with diet and exercise, to lower blood glucose. The drug combines three T2DM treatments: empagliflozin (Jardiance), an SGLT2 inhibitor; linagliptin (Tradjenta), a DPP-4 inhibitor; and metformin HCl extended-release.
Empagliflozin and linagliptin are approved in the US to lower blood sugar in adults with T2DM; empagliflozin is also approved to reduce the risk of cardiovascular (CV) death in adults with T2DM who have known CV disease.
The combination drug is not recommended for people with type 1 diabetes mellitus or diabetic ketoacidosis and should not be used by people who have severe renal impairment, end-stage renal disease, or are on dialysis, or in patients with metabolic acidosis. There have been postmarketing reports of acute pancreatitis, including fatal pancreatitis, in patients taking linagliptin, one component of the combination drug. There is a black box warning for metformin-associated lactic acidosis, which is included for all products containing metformin.
Trijardy XR tablets are marketed by Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company. Consult product labeling for prescribing and important safety information.
First lotion formulation of tazarotene acne treatment approved
Ortho Dermatologics received FDA approval for Arazlo (tazarotene) lotion 0.045% for the topical treatment of acne vulgaris in patients 9 years of age and older. The product is the first tazarotene acne treatment available in lotion form and has been shown to provide strong efficacy with favorable tolerability, according to the manufacturer. The lotion formulation helps minimize the dryness and irritation historically associated with tazarotene use, which can cause many patients to discontinue treatment.
In a head-to-head study, Arazlo (tazarotene) lotion 0.045% demonstrated similar efficacy as Tazorac (tazarotene) cream 0.1%, with about half of the adverse reactions. The most frequent adverse reactions reported with tazarotene included application site pain, dryness, exfoliation, erythema, and pruritus. Tazarotene may cause birth defects if used during pregnancy, and effective birth control must be used during treatment. Consult product labeling for important warnings and precautions.
FDA approves new treatment for adults with migraine
The FDA approved Allergan USA's Ubrelvy (ubrogepant) tablets for the acute treatment of migraine with or without aura in adults. It is the first drug in the class of oral calcitonin gene-related peptide receptor antagonists approved for acute treatment of migraine. Ubrogepant is not indicated for preventive treatment of migraine.
The effectiveness of Ubrelvy for the acute treatment of migraine was shown in two randomized, double-blind, placebo-controlled trials in which 1,439 adult patients with a history of migraine, with and without aura, received ubrogepant to treat an ongoing migraine. In both studies, the percentages of patients achieving freedom from pain 2 hours after treatment and whose most bothersome symptom stopped 2 hours after treatment were significantly greater among patients receiving ubrogepant at all doses compared with those receiving placebo.
The most common adverse reactions in the clinical trials included nausea, tiredness, and dry mouth. Ubrogepant is contraindicated for coadministration with strong CYP3A4 inhibitors.