Roche ane­mia drug ap­proval is de­layed

In good news for ri­val Am­gen, the drug maker says the FDA won’t clear Mircera be­fore a safety re­view this fall.

Los Angeles Times - - Business -

wash­ing­ton — Swiss drug maker Hoff­man-La Roche Inc. said Fri­day that fed­eral reg­u­la­tors stopped short of ap­prov­ing its ane­mia drug that would com­pete against block­buster treat­ments from Am­gen Inc. and John­son & John­son.

The de­lay is good news for in­vestors of biotech gi­ant Am­gen Inc., whose stock dropped more than 15% in the last week be­cause of safety con­cerns over its drugs Aranesp and Epogen. They ac­count for nearly half of the Thou­sand Oaks-based com­pany’s an­nual sales.

Roche, which has U.S. head­quar­ters in Nut­ley, N.J., is seek­ing ap­proval to mar­ket a treat­ment called Mircera in pa­tients whose ane­mia is caused by chronic kid­ney dis­ease.

Al­though a com­pany spokes­woman said the Food and Drug Ad­min­is­tra­tion gave Roche a draft of the drug’s la­bel­ing, fi­nal ap­proval won’t be given un­til af­ter the agency’s meet­ing in the fall on the safety of ane­mia drugs in pa­tients with kid­ney dis­ease.

“Roche will con­tinue to work with the FDA fol­low­ing this meet­ing in or­der to ex­pe­dite the con­clu­sion of the re­view process,” said Ge­orge Aber­crom­bie, Roche chief ex­ec­u­tive.

If ap­proved, Mircera would have a ma­jor ad­van­tage over com­peti­tors: It is given in longer­last­ing monthly doses, com­pared with weekly doses for sim­i­lar drugs from Am­gen and John­son & John­son.

That could help dial­y­sis cen­ter op­er­a­tors, such as El Se­gundo-based DaVita Inc., re­duce the treat­ment costs for kid­ney dis­ease pa­tients.

Last week, an FDA panel rec­om­mended that warn­ing la­bels be added to ane­mia drugs when they are used by can­cer pa­tients, two months af­ter reg­u­la­tors or­dered that ane­mia drug la­bels warn of the risks of blood clots, heart at­tack or death when taken at high doses. The la­bels ap­ply to Am­gen’s two drugs and John­son & John­son’s Pr­o­crit.

Shares of Am­gen rose 71 cents in af­ter-hours trad­ing to $54.75 af­ter end­ing the reg­u­lar trad­ing ses­sion up 36 cents to $54.04.

Newspapers in English

Newspapers from USA

© PressReader. All rights reserved.