Roche anti-anemia drug continues to produce positive data

The positive results from the trials bring the drug a step closer to a regulatory filing for marketing approval.

The studies met their primary endpoints and showed that both intravenous and subcutaneous Cera, when given at extended dosing intervals was effective in maintaining hemoglobin levels.

Generally, the safety profile is characteristic of the population under study. The most common adverse events in all treatment groups were infections, injuries and procedural complications, and gastrointestinal disorders.

“Cera’s unique ability to provide up to once monthly dosing may potentially offer a convenient and efficacious treatment option for patients with anemia in all stages of chronic kidney disease,” said Richard Hinson, vice president of operations, Hoffmann-La Roche.

In these maintenance studies, patients on dialysis and on stable maintenance treatment of anemia with epoetin or darbepoetin were randomized to continue their treatment or switch to Cera given once every two weeks or once every four weeks.

Two studies examining correction of anemia in patients with chronic kidney disease on dialysis and not on dialysis are also nearing completion. The phase II-III program is the largest program ever undertaken for a drug treating anemia, involving more than 2,700 patients from 29 countries.