Rx Product News (April 2020)
PEANUT (ARACHIS HYPOGAEA) ALLERGEN POWDER-DNFP (PALFORZIA)
MANUFACTURED BY: Aimmune Therapeutics
The FDA recently approved peanut (Arachis hypogaea) allergen powder-dnfp, the first drug for the treatment of peanut allergy in children. Treatment includes 3 phases: initial dose escalation, up-dosing, and maintenance. For use, the powder is emptied from the capsules or sachet and mixed with a small amount of semisolid food, which the patient then consumes. Study results showed that 67.2% of patients who received the powder tolerated a 600-mg dose of peanut protein in an oral challenge compared with 4.0% of placebo recipients. The FDA is requiring a Risk Evaluation and Mitigation Strategy with the approval, including elements to assure safe use.
FOR MORE INFORMATION: aimmune.com
MANUFACTURED BY: Horizon Therapeutics
The first FDA-approved treatment for adults with thyroid eye disease, teprotumumab-trbw greatly reduced eye protrusion in these patients, according to the results of a study. Thyroid eye disease is associated with outward bulging of the eye and can cause symptoms such as difficulty closing the eye, double vision, eye pain, and/or light sensitivity. In 2 studies reviewed by the FDA, of patients who received Tepezza, 71% and 83%, respectively, demonstrated a greater than 2-mm reduction in eye protrusion. Common adverse reactions were alopecia, diarrhea, dry skin, dysgeusia, fatigue, headaches, hearing loss, hyperglycemia, muscle spasms, and nausea.
FOR MORE INFORMATION: tepezza.com
FERRIC DERISOMALTOSE INJECTION 100 MG/ML (MONOFERRIC)
MANUFACTURED BY: Pfizer Inc
The FDA has approved ferric derisomaltose injection 100 mg/mL for the treatment of adults with iron deficiency anemia. Although physicians can frequently treat iron deficiency anemia with iron supplementation, some patients may need intravenous iron because of an intolerance to oral iron. In 2 trials cited in the FDA’s decision, 8.6% of patients treated with ferric derisomaltose reported adverse reactions, including nausea (1.2%) and rash (1.0%). Adjudicated or severe hypersensitivity reactions were reported in 0.3% of patients.
FOR MORE INFORMATION: pfizer.com
EMPAGLIFLOZIN/LINAGLIPTIN/METFORMIN HYDROCHLORIDE EXTENDED RELEASE TABLETS
MANUFACTURED BY: Boehringer
Ingelheim Pharmaceuticals, Inc, and Eli Lilly and Company The FDA has granted approval to empagliflozin/linagliptin/metformin hydrochloride triple-combination extended-release tablets, when combined with diet and exercise, for the treatment of adults with type 2 diabetes. In 2 open-label trials assessing the bioequivalence of the 3 drugs and their individual components, the safety profile of the combination tablet was found to be consistent with that of its individual components. The tablets are not intended for patients with diabetic ketoacidosis, end-stage renal disease, metabolic acidosis, and severe kidney problems or for those who are on dialysis. It will be available in 4 dose combinations.
FOR MORE INFORMATION: lilly.com