FDA grants supplemental approval for ACTEMRA (tocilizumab)

Top Quote Genentech, Inc., a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the United States (U.S.) Food and Drug Administration (FDA) has extended the ACTEMRAŽ (tocilizumab, RoACTEMRA in the European Union) label to include inhibition and slowing of structural joint damage. End Quote
  • (1888PressRelease) January 07, 2011 - Improvement of physical function, and achievement of major clinical response in adult patients with moderately to severely active rheumatoid arthritis (RA), when given in combination with methotrexate (MTX).

    The supplemental approval comes one year after initial U.S. approval and supports the efficacy of ACTEMRA in treating RA.

    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. Joint damage often begins early in the disease and can lead to permanent disability; therefore, inhibiting structural damage to patients? joints is a critical measure of the effectiveness of an RA treatment.

    The new U.S. license extension was based on positive data from the Phase III LITHE trial which demonstrated that patients receiving either dose of ACTEMRA (4 mg/kg or 8 mg/kg) in combination with MTX had significantly less damage to their joints at one year, compared to patients in the control group. The outcome was determined by X-rays which measured the progression of bone erosions and narrowing of joint spaces over time.

    "This FDA approval further supports the efficacy of Actemra and follows a similar approval in the EU," said Hal Barron, M.D., chief medical officer and head, Global Product Development. "For those who are faced with the daily challenges of RA, inhibition and slowing of joint damage is imperative if patients are to truly achieve their treatment goals."

    The LITHE study also showed that patients who received either dose of ACTEMRA (4 mg/kg or 8 mg/kg) plus MTX showed significant improvement in physical function, compared with patients who received MTX plus placebo at week 52. More patients treated with ACTEMRA also achieved major clinical response, defined as achieving an ACR 70 response for a continuous 24-week period, compared to MTX plus placebo. No new or unexpected safety signals were identified with ACTEMRA, and safety was consistent with previous studies.

    ACTEMRA was approved by the FDA on January 8, 2010 as the first interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody to treat moderately to severe active RA in adult patients after an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies. It can be used as monotherapy or in combination with MTX or other disease modifying anti-rheumatic drugs (DMARDS).

    The treatment is also approved for use in the European Union and a growing number of other countries including Japan, Mexico, India, Brazil, Switzerland and Australia.

    About the LITHE (TociLIzumab Safety and THE Prevention of Structural Joint Damage) Study
    The LITHE study, a randomized, double-blind, placebo-controlled trial was designed to evaluate the efficacy of tocilizumab plus MTX in preventing structural joint damage and improving physical function over two years. LITHE was an international study, including 15 countries and 1,196 patients with moderately to severely RA who had an inadequate response to MTX. In this randomized study, patients received either ACTEMRA (4 mg/kg or 8 mg/kg, one infusion every four weeks) in combination with MTX or MTX plus placebo. Results from the 12-month analysis showed that ACTEMRA 4 mg/kg slowed (less than 75 percent inhibition compared to the control group) and ACTEMRA 8 mg/kg inhibited (at least 75 percent inhibition compared to the control group) the progression of structural damage compared to MTX plus placebo. At 52 weeks, total Genant-modified Sharp Score change from baseline for the ACTEMRA 8 mg/kg and 4 mg/kg plus MTX, and MTX plus placebo groups was: 0.25, 0.33 and 1.17 respectively. By week 104, the mean change from baseline was 0.34 and 0.47 for the 8 mg/kg plus MTX and 4 mg/kg plus MTX groups respectively.

    The Genant-modified Sharp score focuses on 14 specific sites for evidence of bone erosion and 13 sites for narrowing of the joint space, both key measures of ongoing structural damage to the joints. A high score or an increase in the score over time represents a greater extent of damage. Improvement in physical function was measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI). The HAQ-DI is a questionnaire that asks about physical functioning in the categories of dressing and grooming, arising, eating, walking, hygiene, reach, grip and daily activities. Sixty-three percent and 60 percent of patients in the ACTEMRA 8 mg/kg plus MTX and ACTEMRA 4 mg/kg plus MTX groups respectively, achieved a clinically relevant improvement in HAQ-DI (change from baseline of ≥0.3 units) at week 52 compared to 53 percent in the MTX plus placebo group. Major clinical response, defined as achieving an ACR 70 response for a continuous 24 week period, was achieved in seven percent and four percent in the ACTEMRA 8 mg/kg plus MTX, ACTEMRA 4 mg/kg plus MTX groups, respectively, compared with one percent in the MTX plus placebo group.

    About ACTEMRAŽ (tocilizumab)
    ACTEMRA is the first humanized IL-6 receptor-inhibiting monoclonal antibody approved for the treatment of adult patients with moderately to severely active RA who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies. Studies demonstrate that reducing the activity of IL-6, one of several key cytokines involved in the inflammatory process, relieves both inflammation of the joints and certain systemic symptoms of RA. The extensive ACTEMRA clinical development program included five Phase III clinical studies and enrolled more than 4,000 people with RA in 41 countries, including the United States.

    Some people have serious infections while taking ACTEMRA, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Other serious side effects of ACTEMRA include tears (perforation) of the stomach and intestines, changes in blood test results, hepatitis B infection in those already carrying the virus, nervous system problems, and serious allergic reactions.

    Common side effects with ACTEMRA include upper respiratory tract infections (common cold, sinus infections), headache, and increased blood pressure (hypertension).

    Patients must tell their healthcare providers if they plan to become pregnant or are pregnant. It is not known if ACTEMRA will harm an unborn baby. Genentech has a registry for pregnant women who take ACTEMRA. Patients who are pregnant or become pregnant while taking ACTEMRA must contact the registry at 1-877-311-8972 and talk to their healthcare provider.

    Patients must call their healthcare provider for medical advice about any side effects. Patients or caregivers may report side effects to the FDA at 1-800-FDA-1088. Patients or caregivers may also report side effects to Genentech at 1-888-835-2555.

    For additional important safety information, including Boxed WARNINGS and Medication Guide, please visit http://www.actemra.com or call 1-800-ACTEMRA (228-3672).

    ACTEMRA is part of a co-development agreement with Chugai Pharmaceutical Co. and has been approved in Japan since June 2005. ACTEMRA is approved in the European Union, where it is known as RoACTEMRA, and several other countries, including India, Brazil, Switzerland and Australia.

    About Genentech
    Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit www.gene.com.

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