European News Roundup
pharmafile | March 23, 2007 | News story | Sales and Marketing |Â Â Â
Datamonitor reports on the European market:
Lilly withdraws EU Arxxant application
Eli Lilly has withdrawn a marketing application for diabetic retinopathy drug Arxxant in the EU after the company was not able to respond to a request for additional information in time.
The news follows an announcement from the FDA that it would still need an additional three-year study on the drug before approval in the US, rejecting an appeal from Lilly against the decision.
Arxxant was expected to be used for the treatment of moderate to severe non-proliferative diabetic retinopathy (damage to the blood vessels in the retina) in adult patients. Diabetic retinopathy is a complication of diabetes and can cause severe vision loss or even blindness.
At the time of the withdrawal, it was under review by the Agency's Committee for Medicinal Products for Human Use (CHMP).
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Shire launches Dynepo in Germany
Shire has launched anemia drug Dynepo in Germany, in the first step of a planned European launch.
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."
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