« Back

FDA requests risk plan, nonclinical animal model data before approving Roche, Chugai's Actemra to treat RA

Thursday, December 04 2008 | Comments

---

What's This? The Food and Drug Administration requested that Roche and Chugai Pharmaceutical Co. Ltd. submit a Risk Evaluation and Mitigation Strategy (REMS) plan and additional nonclinical animal model data before it will approve the companies' Biologics License Application (BLA) for Actemra (tocilizumab), an interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody, for the treatment of adult patients with moderate to severe rheumatoid arthritis (RA).

The FDA is requiring a REMS plan to help ensure that the drug is prescribed and administered properly and that patients are fully aware of the risks and benefits associated with the use of Actemra, according to Roche. The company said it is working to comply with the agency's requests and is performing the preclinical studies the FDA asked for "to confirm the published literature showing that Actemra does not affect peri- and postnatal development and fertility."

"Roche will continue to work diligently to fulfill the FDA's requirements, and we anticipate submitting the complete response for Actemra to the agency in the third quarter of 2009," said Jean-Jacques Garaud, the firm's chief medical officer. "Roche remains confident in the future of Actemra and is committed to making this important new therapy available to patients with RA." 

As reported in September, the FDA issued a complete response letter to Roche asking for additional documentation related to the manufacture of Actemra and "certain other outstanding components," such as final labeling, but requiring no new clinical studies. In July, the agency's Arthritis Advisory Committee voted 10-1 in favor of approving Actemra.

Roche and Chugai submitted the BLA for Actemra in November 2007. The application was supported by results from four Phase III trials (OPTION, TOWARD, RADIATE and AMBITION), including extension studies, and an interim analysis of an ongoing fifth Phase III trial (LITHE). Results from the LITHE trial released in October showed that Actemra significantly improved RA remission rates as compared with placebo. Roche noted that more than 4,000 patients have participated in the drug's clinical development program.

Actemra uses genetic recombinant technology and works to reduce the activity of IL-6, a key cytokine involved in the inflammatory process, by blocking IL-6 from binding to its receptor. Studies suggest that decreased activity of IL-6 reduces joint inflammation and relieves some systemic effects of RA.

This information concerns a use that has not been approved by the FDA.

Print  |  E-mail  |  Add this to PeerClip