Trending News Today: FDA Declines Approval to Drug for Rare Genetic Disorder
Top news of the day from across the health care landscape.
Officials with the FDA have declined to approve Acer Therapeutics’ treatment for a severe, rare genetic disorder, Reuters reported. According to the article, Edsivo aims to treat vascular Ehlers-Danlos syndrome (vEDS), the most severe type of a hereditary disorder of the connective tissue that can cause blood vessels to fatally rupture. In a complete response letter, the FDA asked Acer to conduct a clinical trial to determine the efficacy of Edsivo in treating patients with vEDS, the article reported.
The FDA granted Fast Track designation to empagliflozin (Jardiance) for the reduction of the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure, MD Magazine reported. According to the article, the designation is based on the ongoing outcome trial in patients with chronic heart failure (EMPORER) program. Empagliflozin has already received FDA indications as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes and to reduce the risk of cardiovascular death in adult patients with type 2 diabetes and established cardiovascular disease, the article reported.
The Advisory Committee on Immunization Practices voted to raise the recommended vaccination age for the human papillomavirus (HPV) vaccine for men up to age 26, The Associated Press reported. According to the article, women as old as 26 had been recommended to receive a “catch-up” HPV vaccination if they missed the vaccine in pre-adolescence, but the recommendation had only been applied to men up to age 21. The panel decided on Wednesday to equalize the age recommendations to make it easier for physicians, the article reported.