Biogen Rituxan study fails to meet primary endpoint

Biogen has announced today that the phase II/III randomised double-blind study of Rituxan for systemic lupus erythematosus did not meet its primary endpoint.

The endpoint had been defined as the proportion of Rituxan-treated patients who achieved a major clinical response or partial clinical response measured by a special lupus activity response index at 52 weeks.

Moreover, the study failed to meet any of the six secondary endpoints.

“We are disappointed in the results of this phase II/III study, but we understood from the outset the significant challenges in developing treatments for systemic lupus erythematosus,” said Hal Barron, M.D., Genentech senior vice-president, development and chief medical officer.

Rituxan is a therapeutic antibody that first received US Food and Drug Administration in November 1997.

Biogen will continue to analyse the results of the study before submitting the data for presentation at a medical meeting this year.

Last month, Biogen revealed that revenues in the first-quarter had increased 32 per cent to $942 million (470 million pounds) when compared with the same period last year.