FDA Approves First Drug to Treat Group of Rare Blood Disorders in Nearly 14 Years | FDA

FDA Approves First Drug to Treat Group of Rare Blood Disorders in Nearly 14 Years | FDA

FDA Approves First Drug to Treat Group of Rare Blood Disorders in Nearly 14 Years

Today, the U.S. Food and Drug Administration approved Nucala (mepolizumab) for adults and children aged 12 years and older with hypereosinophilic syndrome (HES) for six months or longer without another identifiable non-blood related cause of the disease. The new indication for Nucala is the first approval for HES patients in nearly 14 years. The most common side effects of Nucala in patients with HES include: upper respiratory tract infection and pain in extremities (such as the hands, legs and feet). Nucala should not be administered to patients with a history of hypersensitivity to mepolizumab or one of its ingredients. Herpes zoster (shingles) infections have occurred in patients receiving Nucala. Health care providers should consider vaccination if medically appropriate.