Johnson & Johnson’s Janssen-Cilag unit Monday said it plans to start talks with the French Health Authority to change the European labeling of its Eprex/Erypo drug, in an attempt to stave off a possible banning of the anemia drug.
The announcement comes a few days after reports that European pharmaceutical regulators are considering banning the drug for patients with chronic kidney failure.
Although the drug could still be used to treat patients with anemia caused by cancer chemotherapy, such a move by regulators could cost New Brunswick, New Jersey-based Johnson & Johnson several hundred million dollars in sales and be a boon for rivals Roche Holdings AG and Amgen Inc., each of which sells a similar drug.
Eprex has been linked to 160 cases of pure, red-cell aplasia, a condition that can destroy patients’ ability to make oxygen-carrying red blood cells, leaving them dependent on blood transfusions to survive.
Most of the reported pure red cell aplasia cases, as of June, have been associated with subcutaneous administration, the typical method of use in most countries. As a result, Johnson & Johnson’s Janssen-Ortho unit urged doctors to administer the drug intravenously to patients suffering from kidney failure.
According to a New York Times article on Saturday, regulators are alarmed that the cases of the side effect have occurred during the last three years, although the drug has been on the market for about a decade. That suggests that the problems stem from some change in the way the drug is made or administered.
The American version of the product, which is sold as Procrit by Johnson & Johnson and Epogen by Amgen, is made separately by Amgen and has been associated with only a handful of cases of aplasia.
Eprex and Procrit accounted for $3.4 billion of Johnson & Johnson’s total sales of $33 billion last year, making the drug the company’s biggest-selling product, The New York Times reported.
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