Shire launches Dynepo in Germany

The launch of the erythropoiesis-stimulating agent, which increases the production of red blood cells, coincides with an FDA warning on the drug class. The US drug regulator recently added a “black box” to the labels of anemia drugs produced by Amgen and Johnson & Johnson recommending physicians not to exceed the approved dose strength.

Shire said that Dynepo is unique as it is the only ESA produced in human cells, while all other commercially available ESAs are presently made in animal cells. The drug is approved for use in patients not yet requiring dialysis as well as those with end-stage renal disease on dialysis.

UK-based Shire said that Dynepo will be available in other European markets in the coming months, and the company priced the drug at a 30% discount to rival products.

Mike Cola, president of Shire’s specialty pharmaceuticals business, said: “The launch of Dynepo is another milestone in Shire’s continuing efforts to focus on improving health outcomes for patients with renal disease and servicing renal units with specialty pharmaceuticals.”