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BREAKING NEWS
Source: US FDA  Jan 13, 2019  5 years, 3 months, 6 days, 16 hours, 34 minutes ago

FDA approves Ultomiris (Ravulizumab) as new treatment for adult patients with PNH.

FDA approves Ultomiris (Ravulizumab) as new treatment for adult patients with PNH.
Source: US FDA  Jan 13, 2019  5 years, 3 months, 6 days, 16 hours, 34 minutes ago
The U.S. Food and Drug Administration today approved Ultomiris (ravulizumab) injection for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare and life-threatening blood disease.
FDA approves

“The approval of Ultomiris will change the way that patients with PNH are treated,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Prior to this approval, the only approved therapy for PNH required treatment every two weeks, which can be burdensome for patients and their families. Ultomiris uses a novel formulation so patients only need treatment every eight weeks, without compromising efficacy.”

PNH is a rare acquired disorder that leads to the rupture or destruction of red blood cells (hemolysis). Patients with PNH are missing a certain protein that normally protects red blood cells from being destroyed by the patient’s immune system.

Patients with PNH have sudden, recurring episodes where red blood cells are prematurely destroyed which may be triggered by stresses on the body, such as infections or physical exertion. During these episodes, the following symptoms may occur: severe anemia, profound fatigue, shortness of breath, intermittent episodes of dark colored urine, kidney disease or recurrent pain. PNH can occur at any age, although it is most often diagnosed in young adulthood.

Ultomiris is a long-acting complement inhibitor that prevents hemolysis. The efficacy of Ultomiris was studied in a clinical trial of 246 patients who previously had not been treated for PNH (treatment naïve), who were randomized to be treated with Ultomiris or ecu