UPDATE 1-Roche anemia drug's U.S. approval delayed
(Adds company comment, background, changes dateline from WASHINGTON)
NEW YORK, May 18 (Reuters) - Roche Holding AG's (ROG.VX) anemia drug, Mircera, was deemed "approvable" by U.S. regulators for treating patients with kidney disease, but the company said outright approval to sell the drug would likely be delayed at least until the third quarter.
The Swiss drugmaker said on Friday it expected the medicine's label to be finalized after a U.S. Food and Drug Administration advisory panel issues recommendations on the entire Epo class of anemia drugs now under scrutiny because of concerns about safety and their potential overuse.
The FDA panel of outside kidney experts is expected to meet this autumn.
"We are confident that Mircera will be approved in the United States and we understand and support the FDA's initiative to convene an advisory panel to review the use of anemia agents in the renal setting," George Abercrombie, chief executive of Roche's Hoffmann-La Roche unit, said in a statement.
If approved, Mircera will compete with Amgen Inc.'s (AMGN.O) Epogen and Aranesp and Johnson & Johnson's (JNJ.N) Procrit.
Amgen has been fighting the Roche drug on several legal and regulatory fronts, alleging it infringes Amgen patents.
Roche has argued its drug is different, claiming Mircera is longer lasting than other available anemia drugs.
The drugs belong to a class known as erythropoiesis- stimulating agents, which are used to boost red blood cells in anemia patients to help avoid the need for blood transfusions.
The FDA panel meeting is expected to make recommendations that, if adopted, could impact the entire class of drugs.
Roche said it will continue to work with the FDA following the meeting to expedite the review process for its drug.
A similar panel of cancer experts reviewed the use of the drugs in oncology patients this month and made several recommendations that would restrict their use, sparking a steep decline in Amgen's share price.
The Mircera delay will be viewed as a positive by investors in Amgen's beaten down shares, analysts said.
