Rituxan's sBLA receives a Complete Response from the FDA

Genentech, Inc. a wholly-owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), and Biogen Idec (Nasdaq:BIIB) announced today that the companies received a Complete Response from the U.S. Food and Drug Administration (FDA) for a supplemental Biologics License Application (sBLA) for Rituxan^® (rituximab) plus methotrexate (MTX) in patients with moderately-to-severely active rheumatoid arthritis (RA) who no longer respond to treatment with a disease modifying antirheumatic drug (DMARD), including MTX.

The FDA has indicated that they do not believe an approval for Rituxan (in people with RA who have not previously received MTX or those who were MTX inadequate responders) can be supported at this time due to the rare risk of progessive multifocal leukeoencephalopathy (PML) in light of the number of effective RA treatments currently available to patients in earlier stages of the disease. PML is a usually fatal brain disease caused by the reactivation of a common virus called the JC virus. Although the incidence of PML in RA patients treated with Rituxan is rare (as of today, three reports out of approximately 100,000 patients), there are no known reliable PML treatments.

The FDA approved an additional sBLA submission today to include updated safety and efficacy data in the label that provides guidance on how later-stage patients, those who have inadequately responded to tumor necrosis factor (TNF)-antagonist therapies, can be retreated with Rituxan. The prescribing information will now include language that subsequent courses of the standard Rituxan regimen (two doses at 1000 mg each) can be administered every 24 weeks or based on clinical evaluation. Subsequent courses should not be administered sooner than 16 weeks. Rituxan’s ability to improve physical function and slow joint damage for up to two years as demonstrated in clinical studies has also been added.

Rituxan was approved for patients with moderately-to-severely active RA who have inadequately responded to one or more tumor necrosis factor (TNF)-antagonist therapies in 2006.

The current indications for Rituxan in certain blood cancers remain unchanged. Additionally, the companies remain committed to their development programs for other anti-CD20 molecules in both oncology and immunology.

“We are committed to patient safety and understand the Agency’s decision, given the uncertainty regarding the risk of PML, and we will discuss next steps with the FDA to determine an appropriate path forward,” said Hal Barron, M.D., executive vice president, Global Development and chief medical officer, Genentech. “We are encouraged by the FDA’s decision to support retreatment for people in later stages of RA and continue to believe that Rituxan is effective in this setting.”

“In more than eight large studies conducted, Rituxan has demonstrated that it can improve the symptoms of RA, an often debilitating disease,” said David Hagerty, M.D., vice president and chief medical officer, Rheumatology, Biogen Idec. “Patients living with moderate-to-severe RA who have limited treatment options continue to benefit from Rituxan.”

Both applications included data from five Rituxan Phase III RA studies: SUNRISE, REFLEX, SERENE, IMAGE and MIRROR, in addition to long-term safety data from the overall RA clinical trial experience.