Newly-Branded Azurity Wins FDA Approval for Liquid Form of Amlodipine
Privately-held Azurity Pharmaceuticals won approval for a liquid form of a hypertension drug for both adult and pediatric patients.
This morning, Woburn, Mass.-based Azurity said the U.S. Food and Drug Administration (FDA) approved Katerzia (amlodipine) Oral Suspension. This is the only FDA-approved amlodipine oral suspension, the company said. Katerzia is indicated for the treatment of hypertension (high blood pressure) in adults and pediatric patients six years of age and older and coronary artery disease in adults. Amlodipine is a calcium channel blocker that dilates blood vessels and improves blood flow in patients with hypertension, as well as other conditions caused by coronary artery disease.
Hypertension is a common ailment, occurring in about 75 million American adults. Hypertension, which often goes uncontrolled, increases the risk for heart disease and stroke, which are two of the leading causes of death for adults in the United States. Hypertension in children and adolescents is a growing concern. According to the U.S. Centers for Disease Control and Prevention, about 4% of youth aged 12–19 years have hypertension, and another 10% have elevated blood pressure, previously called pre-hypertension.
Azurity is a newly branded specialty pharma company formed last month following CutisPharma’s acquisition of Silvergate Pharmaceuticals, Inc. The unified company rebranded itself as Azurity Pharmaceuticals. Azurity focuses on the needs of patients, particularly children and the elderly, who require customized, user-friendly drug formulations. The approval of Katerzia is the first product approval since the formation of the unified companies. The company did not provide details on list pricing or when the medication will be available to patients.
Neal Muni, president and chief executive officer of Azurity, called it an exciting time for the merged companies. Muni said the addition of Katerzia complements the company’s existing pediatric hypertension portfolio and “will strengthen the overall offering from Azurity.”
In addition to Katerzia, Azurity has several FDA-approved products in its portfolio. Epaned is an oral solution of Enalapril, another hypertension treatment for adults and pediatric patients. Qbrelis is an oral solution of Lisinopril, a hypertension treatment for pediatric patients. Xatmep is an oral solution for pediatric patients with acute lymphoblastic leukemia. Firvanq is an oral treatment for adults and pediatric patients who have Clostridium difficile-associated diarrhea and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains. Firvanq was approved by the FDA last year. At the time of its approval, it was the only FDA-approved vancomycin oral liquid treatment option for those indications.