Anemia Drugs: What Next

It looks like the problems for this group of drugs is unending.

Following FDA scrutiny a revised statement about potential risks of anemia drugs in CKD patients has been approved.

The FDA said the label changes for Aranesp, Epogen and Procrit also include a statement that symptoms of anemia, fatigue and quality of life have not been shown to improve in patients with cancer who take these drugs.

In case of cancer patients, the new boxed warnings stress that ESAs caused tumor growth and shortened survival in patients with advanced breast, head and neck, lymphoid and non-small cell lung cancer, when they received doses exceeding the prescribed levels.

The FDA also stated that the drugs have been used in patients who apparently had hemoglobin levels of 12 grams per deciliter or higher. However these drugs are to be used to maintain hemoglobin levels of 10 to 12 grams per deciliter for safety reasons.

Smaller doses of the drugs are recommended. There have already been a lot of controversies around the overuse of these drugs.

On another front the anemia drugs face a challenge from Roche’s Mircera that has received FDA approval to treat anemia in kidney failure patients. However, the drug awaits resolution of a patent infringement case before it can be launched.

The launch of Mircera means a significant milestone for Roche while it could turn out to be a nightmare for Amgen, as it threatens to break Amgen’s monopoly.

Roche is considering appealing the decision, while Amgen seeks to obtain an official injunction to stop the sale of Mircera in the U.S. With an injunction in place, Roche probably will not have a chance to sell the product in the U.S. until at least 2012, when the first patents on Amgen's anemia drugs expire. Analysts are certain that Amgen will prevail in the court battle.


- Roopa S