Dynepo gene activated human erythropoietin regulatory update

The FDA requested data on additional manufacturing runs of Dynepo, which is under review in the U.S. and Europe to treat anemia in dialysis and non-dialysis patients with chronic renal failure, based on an increase to the 5,000 liter scale in the product's manufacturing process. TKTX said the additional process validation data will require submission of a new BLA for Dynepo to the FDA, which is expected to be made in six months. ...