Roche Says Mircera Filings in Europe, U.S. Proceeding as Planned

Roche's pending applications for investigational erythropoiesis-stimulating agent (ESA) Mircera in the U.S. and Europe are proceeding according to plan, William Burns, CEO of Roche's pharma division, said.

Safety concerns with ESAs prompted recent congressional scrutiny following an FDA announcement warning physicians about use of the ESAs for both oncology and end-stage renal disease. Roche has previously halted a Phase II dose-finding trial of Mircera in non-small-cell lung cancer patients with chemotherapy-induced anemia.

"All the significant issues are behind us. We're now talking labeling and some of the fine tuning," Burns said. "There's a very clear understanding that the renal anemia is a different segment than the cancer area and we see no influence at the moment with our interactions with the regulators coming from that."

Additionally, Burns said Roche's investigational humanized anti-interluekin-6 receptor monoclonal antibody for treating rheumatoid arthritis, Actemra (tocilizumab), was on track for submission in the U.S. and Europe this year. Last year's submission of the drug in Japan is also progressing as planned, he said.