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FDA News and Updates | US Pharma News | iPharmaCenter

FDA approved Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) as oral medications for the treatment of type 2 diabetes in children aged 10 years and older. These approvals mark a new class of medicines for pediatric type 2 diabetes, alongside metformin which has been approved for pediatric use since 2000.

Jardiance was initially approved in 2014 in adults with type 2 diabetes, while Synjardy received its approval in 2015.

The safety and effectiveness of empagliflozin in children were evaluated in a double-blind, randomized trial involving 157 patients aged 10 to 17 years who had inadequately controlled type 2 diabetes. The participants were assigned to one of three treatment groups for 26 weeks: empagliflozin, a DPP-4 inhibitor called linagliptin, or placebo. The trial showed that empagliflozin was superior to placebo in reducing hemoglobin A1c, an indicator of average blood sugar levels. Patients treated with empagliflozin experienced a 0.2% decrease in hemoglobin A1c compared to an increase of 0.7% in the placebo group. Empagliflozin treatment also led to reductions in fasting plasma glucose levels compared to placebo.

Common side effects in children treated with empagliflozin were generally similar to those reported in adults, with the exception of a higher risk of hypoglycemia (low blood sugar) in pediatric patients aged 10 years and older taking empagliflozin, regardless of other diabetes therapies they were receiving.

Both Jardiance and Synjardy received priority review designations from the FDA.

Regeneron and Sanofi have submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Dupixent (dupilumab) as a potential treatment for chronic spontaneous urticaria (CSU). Dupixent is under review for adults and adolescents aged 12 years and older who were not adequately controlled with the standard of care.

CSU causes hives that can cause severe itching and discomfort for patients. CSU is a debilitating condition that can significantly impact a patient's quality of life and has been associated with depression and anxiety. It is usually treated with H1 antihistamines.

The sBLA submission was based on data from two Phase 3 clinical trials, LIBERTY-CUPID Studies A and B. Studies A include patients who have uncontrolled CSU while on the standard of care and Study B includes patients who have uncontrolled CSU while on the standard of care and are refractory to Xolair.

Dupixent is a monoclonal antibody that inhibits the signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13). Dupixent is approved for treating atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyps.


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