FDA approves Reblozyl

Adult patients with beta thalassemia, who need regular red blood cell transfusions, have access to Reblozyl which has now been approved by the FDA. Approval came on the back of results of a trial involving three hundred and thirty six patients with beta thalassemia that needed red blood cell transfusions. The overall evidence conducted from the trial showed patients required less transfusions over twelve weeks while taking Reblozyl. There is a caveat however – women who are pregnant or breastfeeding can’t take Reblozyl because it can injure a new born baby. Also, Reblozyl comes with side effects such as hypertension, bone pain, cough, diarrhoea, dizziness, fatigue, abdominal pain and headaches.
Director of the FDA Oncology Centre of Excellence, Richard Pazdur, said: “When patients receive multiple blood transfusions, there is a risk for iron overload, which can affect many organs. Today’s approval provides patients with a therapy that, for the first time, will help decrease the number of blood transfusions. This approval is an example of our continued progress for rare diseases and providing important new drugs to patients earlier.”