FDA approves first treatment for thyroid eye disease
Tepezza (teprotumumab-trbw), a human monoclonal antibody administered via I.V. infusion, has been approved for the treatment of thyroid eye disease. The drug works by binding to insulin-like growth factor 1 receptors and blocking their activation and signaling. According to the FDA, Tepezza has the potential to alter the course of the disease, potentially sparing patients from needing multiple invasive surgeries.
Tepezza was approved based on the results of two studies with 170 patients. Patients who received the study drug demonstrated greater reduction in proptosis compared with those who received placebo. The most common adverse reactions reported were muscle spasm, nausea, alopecia, diarrhea, fatigue, hyperglycemia, hearing impairment, dry skin, dysgeusia, and headache. Tepezza is a product of Horizon Therapeutics.
Extended-release liquid metformin suspension
Riomet ER (metformin HCl extended-release oral suspension) is now being marketed as an adjunct to diet and exercise to improve glycemic control in patients 10 years of age and older with type 2 diabetes mellitus. The oral suspension is a product of Sun Pharma. It is the first and only approved extended-release liquid formulation of metformin.
The oral suspension is dosed once daily and can be prepped and poured, eliminating the need to crush medication. According to Sun Pharma, the new product offers dosing flexibility and an acceptable taste, and addresses the needs of the 40% of US adults who cannot or will not swallow solid medications.
First drug for peanut allergy treatment in children
Palforzia (Peanut [Arachis hypogaea] Allergen Powder-dnfp) was approved for the mitigation of allergic reactions, including anaphylaxis, which may occur with accidental exposure to peanuts. The powder can be initiated in children ages 4 to 17 years with a confirmed diagnosis of peanut allergy and may be continued in individuals 4 years of age and older. The powder helps reduce the risk of allergic reactions in children with peanut allergy when used in conjunction with peanut avoidance.
Palforzia is made from peanuts and packaged in color-coded, pull-apart capsules. The powder is mixed with a small amount of semisolid food to be consumed by the patient, and treatment is in three phases: initial dose escalation (a single day), up-dosing (11 increasing dose levels over several months), and maintenance. Initial dose escalation and the first dose of each up-dosing level are administered under a healthcare professional's supervision in a healthcare setting that can manage potentially severe allergic reactions, including anaphylaxis. Patients may begin the daily maintenance dose after completing all up-dosing levels. Approval of Palforzia was granted to Aimmune Therapeutics.
New orally disintegrating tablet for acute migraine
The FDA approved Nurtec ODT (rimegepant) for the acute treatment of migraine with or without aura in adults. Rimegepant is a calcitonin gene-related peptide receptor antagonist administered via an orally disintegrating tablet (ODT). Nurtec ODT is a product of Biohaven.
The approval was based on clinical trial data showing that a significantly greater proportion of patients treated with Nurtec ODT achieved freedom from headache and freedom from most bothersome symptom 2 hours after a single dose compared with placebo. In addition, Nurtec ODT was associated with significant improvements in key secondary endpoints compared with placebo, such as sustained pain freedom at 2 to 48 hours and use of rescue medication within 24 hours.