Trending News Today: FDA Grants Orphan Drug Status to Fasenra for Eosinophilic Oesophagitis
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Officials with the FDA granted orphan drug status to AstraZeneca’s benralizumab (Fasenra) for the treatment of eosinophilic esophagitis (EoE), Reuters reported. According to the article, EoE is a rare, chronic, inflammatory disease that occurs when eosinophils, a type of white blood cell, accumulate in the esophagus causing injury and inflammation. Benralizumab is currently approved as an add-on maintenance treatment for severe, eosinophilic asthma, the article reported.
AstraZeneca’s dapagliflozin (Farxiga) received fast track status from the FDA for the prevention of kidney failure and cardiovascular and renal death in patients with chronic kidney disease (CKD), The American Journal of Managed Care reported. According to the article, the announcement will allow regulators to expedite their review of the ongoing phase 3 DAPA-CKD study to determine its impact on renal outcomes and cardiovascular mortality in patients with CKD, with and without type 2 diabetes, on top of standard of care. The fast track designation follows findings from last year’s DECLARE-TIMI trial, which showed dapagliflozin’s significant impact on delaying the loss of kidney function and reducing hospitalization risk for heart failure, the article reported.
Women are more likely than men to not take their diabetes medication as prescribed due to drug costs as are adults under age 65, The Center for Biosimilars reported. According to the article, the CDC report looked at data from the 2017-2018 National Health Interview Survey, which examined who was more likely to ration diabetes medications as a cost-savings measure during the past 12 months. Among adults with diagnosed diabetes, women (14.9%) were more likely than men (11.6%) not to adhere to their medication regimen as prescribed, although they were as likely to ask their physician for lower-priced medication (25.5% versus 23.4%), the article reported.