Genentech's ACTEMRA approved to treat RA

Jan 8 2010

Genentech, Inc., a wholly owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) approved ACTEMRA^® (tocilizumab) for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies. ACTEMRA is the first interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody approved to treat RA, and may be used alone or in combination with methotrexate or other disease modifying anti-rheumatic drugs (DMARDs).

“The FDA approval of ACTEMRA marks a major step forward in the treatment of RA, providing a new option for patients with this very serious disease”

"The FDA approval of ACTEMRA marks a major step forward in the treatment of RA, providing a new option for patients with this very serious disease,” said Hal Barron, M.D., executive vice president, Global Development and chief medical officer, Roche and Genentech. “We are optimistic that working with the agency, we will be able to generate the additional data required to support approval in earlier lines of RA therapy and are committed to comprehensively characterizing both the clinical benefit and the safety of ACTEMRA in earlier lines of therapy through our large pharmacovigilance program, including the risk management program, and ongoing clinical and post-marketing studies globally."

RA is a chronic, progressive inflammatory disease of the joints and surrounding tissues that is associated with intense pain, irreversible joint destruction and systemic complications. There are several key cytokines, or proteins, involved in the inflammatory process, including IL-6. Research shows that IL-6 levels are elevated in patients with RA. ACTEMRA is the first medication designed to specifically inhibit the biological activity of IL-6.

“For many RA patients, treatment with existing therapies does not resolve the painful and debilitating symptoms of the disease,” said Mark Genovese, M.D., ACTEMRA study investigator and Professor of Medicine and Co-Chief of the Division of Immunology and Rheumatology at Stanford University Medical Center. “Data from the clinical development program clearly establish ACTEMRA and its unique mechanism of action as an important new option for RA patients who experience continued disease symptoms despite treatment with existing therapies.”

ACTEMRA has been studied in five multi-national Phase III studies, involving more than 4,000 patients, making it the largest clinical development program for an indication in RA to date. The studies showed that ACTEMRA – alone or in combination with methotrexate or other DMARDs – significantly reduced RA signs and symptoms compared with DMARDs alone. This approval is based on data from the following studies:

• RADIATE (RheumAtoiD ArthritIs Study in Anti-TNF FailurEs) Trial:
  • 50% and 30% of patients who received ACTEMRA 8 mg/kg or 4 mg/kg plus methotrexate, respectively, achieved ACR20 at week 24, compared with 10% of patients who received placebo plus methotrexate¹
• OPTION (TOcilizumab Pivotal Trial in Methotrexate Inadequate respONders) Trial:
  • 59% and 48% of patients who received ACTEMRA 8 mg/kg and 4 mg/kg plus methotrexate, respectively, achieved ACR20 at week 24, compared with 27% of patients who received placebo plus methotrexate²
• TOWARD (Tocilizumab in cOmbination With traditional DMARD therapy) Trial:
  • 61% of patients who received ACTEMRA 8 mg/kg plus DMARDs achieved ACR20 at 24 weeks, compared with 25% of patients treated with DMARDs plus placebo³
• AMBITION (Actemra versus Methotrexate double-Blind Investigative Trial In mONotherapy) Trial:
  • 70% of patients who received ACTEMRA 8 mg/kg achieved ACR20 at week 24, compared with 53% of patients receiving methotrexate alone⁴
• LITHE (TociLIzumab Safety and THE Prevention of Structural Joint Damage) Trial:
  • 56% and 51% of patients who received ACTEMRA 8 mg/kg or 4 mg/kg plus methotrexate, respectively, achieved ACR20 at week 24 compared with 27% of patients who received placebo plus methotrexate⁵

ACTEMRA is approved for once-a-month intravenous administration in doctors’ offices, hospitals and infusion centers, and may be used alone or in combination with methotrexate or other DMARDs in the following dosage:

• ACTEMRA 4 mg/kg is the recommended starting dose when used in combination with DMARDs or as a monotherapy in patients who have had an inadequate response to one or more TNF antagonists; the dose may then be increased to 8 mg/kg based on clinical response.

ACTEMRA has been approved with a Risk Evaluation and Mitigation Strategy (REMS) that includes a medication guide, communication plan and timetable for submission of assessments. This plan was developed to provide support and education to patients and healthcare providers. ACTEMRA will be available the week of January 18, 2010.