J&J Add Warning To Drug Label. Johnson & Johnson said Monday that it asked European regulators to add a warning to the label of its biotech anemia drug, a move that could benefit a rival product from Amgen Inc.
J&J said that the label should warn kidney disease patients not to take Eprex by injection into the skin but by intravenous infusion. About 160 European patients who used the drug developed a rare condition called pure red cell aplasia, in which the body loses its ability to make red blood cells. Patients depend on blood transfusions to survive.
Nearly all patients who developed the condition received Eprex by injection.
J&J said it reached the decision about the label change after consulting with French authorities. European Union regulators have 24 hours to comment on the label change, which could drive a portion of Eprex’s $1 billion in sales to Amgen or Swiss drug maker Roche Group.
Eprex is a synthetic version of erythropoietin, or EPO, the protein that spurs red blood cell production. J&J sells it in Europe under an exclusive license from Thousand Oaks-based Amgen, which markets its own version of EPO to dialysis patients in the United States.
Analysts said Amgen’s drug Aranesp, a modified version of EPO, could get a lift from J&J’s woes. Aranesp, launched a year ago, is more costly than Eprex. But less medication is needed when the drugs are taken by injection. So injectable Aranesp compares favorably with intravenous Eprex, Amgen says.
Concerns in Europe are Linked to Formulation Changes
The concerns in Europe are linked to formulation changes in J&J’s Eprex, and that formula is not marketed in the U.S.
J&J closed at $55.70, down $1.32 on the New York Stock Exchange. Amgen closed at $48.57, up $1.37 on Nasdaq.
Also on Monday, Amgen said that it could provide Enbrel to all patients on a waiting list for the rheumatoid arthritis drug, which has been in short supply since last December.
The company said it was too soon to know how many of the 40,000 patients on the list still want Enbrel, the crown jewel of Amgen’s $9.6-billion purchase of Immunex Corp. Many patients switched to competing prescription medications during the firms’ production problems.
Amgen said the announcement is not related to the completion of a Rhode Island factory that should double Enbrel supplies. Amgen expects regulatory approval of the facility by early next year, just as a rival drug from Abbott Laboratories is expected to reach the market.
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