Roche: RoACTEMRA Gets EU Approval For Rheumatoid Arthritis
January 21 2009 - 2:04AM
Dow Jones News
Swiss drugmaker Roche Holding AG (ROG.VX) said Wednesday the
European Commission has approved RoACTEMRA, or tocilizumab, known
as Actemra outside of the EU, to treat patients with rheumatoid
arthritis.
RoACTEMRA, in combination with methotrexate (MTX), is indicated
for the treatment of adult patients with moderate to severe RA who
have either responded inadequately to, or who were intolerant to,
previous therapy with one or more disease modifying anti-rheumatic
drugs (DMARDs) or tumour necrosis factor (TNF) antagonists. In
these patients, RoACTEMRA can be given as monotherapy in cases of
intolerance to methotrexate (MTX) or where continued treatment with
MTX is inappropriate.
RoACTEMRA is the first interleukin-6 (IL-6) receptorinhibiting
monoclonal antibody developed for the treatment of RA and is a
novel approach to help tackle this debilitating disease.
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 such as
fatigue and anemia. There are several key cytokines, or proteins,
involved in the inflammatory process including tumor necrosis
factor (TNF) alpha, interleukin-1 (IL-1) and interleukin-6 (IL-6).
IL-6 has been identified as having a pivotal role in the
inflammation process. The exact cause of RA is unknown and there is
no cure currently available.
"Many patients suffering from rheumatoid arthritis fail to
respond to any treatment and few actually achieve lasting
remission, which is currently the ultimate goal of treatment for
RA. The approval of RoACTEMRA offers new hope for patients
suffering from the debilitating effects of rheumatoid arthritis"
said William M. Burns, CEO of Roche's Pharmaceuticals Division.
"Roche will work with the authorities in EU member countries to
ensure that this groundbreaking therapy will be available to
patients as quickly as possible."
The European Commission's approval for RoACTEMRA was based on
results from the largest clinical program undertaken by a biologic
in RA including, five multi-national Phase III studies which
demonstrated that treatment with RoACTEMRA - alone or combination
with MTX or other DMARDs- significantly reduced RA signs and
symptoms, compared with current DMARDs alone. These benefits were
regardless of previous therapy or disease severity.
The approval in the EU follows earlier approvals for the product
in several countries, including Japan, India and Switzerland.
Company Web Site: http://www.roche.com
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