Arava to beat Celebra to Market?
Friday August 7, 5:11 pm Eastern Time
Company Press Release
SOURCE: Hoechst Marion Roussel
Hoechst Marion Roussel's Arava(TM) Recommended for
Approval By FDA Advisory Committee for Treatment of
Adult Rheumatoid Arthritis (RA)
Provides Hope for More Than Two Million RA Patients in Need of New,
Effective Treatments
KANSAS CITY, Mo., Aug. 7 /PRNewswire/ -- Hoechst Marion Roussel, the pharmaceutical
company of Hoechst AG, announced today that the Arthritis Advisory Committee of the U.S. Food
and Drug Administration (FDA) has unanimously recommended approval of Arava(TM)
(leflunomide) for the treatment of active rheumatoid arthritis (RA) in adults. If approved, Arava will
be the first new disease modifying agent specifically developed for the treatment of rheumatoid
arthritis -- a potentially crippling disease that affects more than 2 million Americans -- in more than a
decade.
The committee specifically recommended that Arava be approved for relief of signs and symptoms
and for retardation of structural damage in RA. In addition, the committee recommended that the
FDA consider including language in the labeling regarding improvement in physical function.
The recommendations were based in part on a review of pivotal placebo- controlled Phase III
clinical trials presented at the meeting. The efficacy of Arava may be a result of its unique
mechanism of action that works by reversibly inhibiting an enzyme (DHODH) involved in the
autoimmune process that leads to rheumatoid arthritis.
''Patients with rheumatoid arthritis need new disease-modifying treatment options because most of
the existing therapies lose effectiveness over time and have a high frequency of side effects. Studies
have shown Arava to be effective and well tolerated by patients in all stages of disease and that it
slows joint deterioration,'' said Marc C. Hochberg, M.D., M.P.H., professor of medicine and
epidemiology and preventative medicine and the head of the division of rheumatology & clinical
immunology at the University of Maryland School of Medicine in Baltimore. ''Since studies have
shown that structural joint damage often starts during the first two years after disease onset, early
diagnosis and treatment are critical. The availability of a new drug like Arava, that has been used
safely and effectively during both early and more advanced disease, would represent a very
important step in improving the management of RA,'' said Dr. Hochberg, who presented the clinical
perspective at today's FDA advisory committee meeting.
The committee's favorable recommendation, although not binding, will be considered by the FDA in
its final review of the New Drug Application (NDA) which was submitted by Hoechst Marion
Roussel in March 1998. The FDA placed Arava on a six-month priority review schedule based on
the drug's potential therapeutic benefits and the need for new rheumatoid arthritis therapies.
''We are extremely pleased with the panel's decision and will continue to work closely with the
FDA to make Arava available as quickly as possible,'' said Gerald P. Belle, president, Hoechst
Marion Roussel North America. ''Rheumatoid arthritis can be a very devastating illness that limits a
person's ability to participate in everyday activities. We look forward to offering patients a new
treatment option that will help them remain independent and active throughout the course of their
disease.''
Rheumatoid Arthritis: A Debilitating Disease
Rheumatoid arthritis (RA), is one of the most common and severe forms of arthritis. It is a chronic
and often debilitating autoimmune disease in which the body's immune system attacks joint tissue,
leading to pain, inflammation, deformity and disability that can be permanent. While the cause of RA
is not yet known, genetic predisposition plays a role as well as possible hormonal influences and
environmental factors such as a bacterial or viral infection triggers.
RA generally begins with inflammation (e.g., redness, warmth and swelling) in the joints, most
commonly the wrist and finger joints closest to the hands, but can also affect the elbows, shoulders,
neck, jaw, hips, knees, ankles and feet. In some patients, RA can involve internal organs causing
serious damage including inflammation of blood vessels, the lung and the lining surrounding the heart.
RA can affect people of all ages, but usually begins in middle age. The disease is approximately
three times more common in women than in men. In the United States, approximately 1.5 million
women have RA, representing more than 70 percent of all RA cases. Approximately 50 percent of
all RA patients must stop working within 10 years.
Arava was generally well tolerated in clinical studies. The most common side effects associated with
Arava, which were generally reversible and not severe, included diarrhea, rash, alopecia (transient
hair loss) and elevated liver function tests. The committee further recommended that Arava not be
used in pregnant women or in patients with significant liver disease. Arava has only been studied in
adults.
Hoechst Marion Roussel USA is a leader in pharmaceutical-based health care, dedicated to moving
beyond medicine to health(TM) through the discovery and delivery of prescription drugs and the
provision of value-added patient support programs. The global headquarters of Hoechst Marion
Roussel is in Frankfurt, Germany, and the North American headquarters is in Kansas City,
Missouri.
SOURCE: Hoechst Marion Roussel |
