KANSAS CITY, Mo., Sept. 4 /PRNewswire/ -- Expressing confidence that the
issues can be resolved quickly and effectively, Teva Marion Partners said it
received a letter of warning on August 27, 1998 from the Food and Drug
Administration. The letter addressed the wording in several promotional and
advertising pieces about COPAXONE(R) (glatiramer acetate for injection).
No safety concerns were raised about the product. The letter expresses
concern that the potential interpretation of certain promotional materials may
lead readers to conclusions not fully supported by blinded, placebo-controlled
clinical trials.
"We take this communication very seriously, and began discussion with the FDA
immediately," said John Vandewalle, M.D., chief executive officer of Teva
Marion Partners. "The issue is not the product's safety, effectiveness or its
prescribed use, but concerns possible interpretation of some promotional
materials. We will work with the FDA to make sure these issues are resolved."
"COPAXONE(R) (glatiramer acetate for injection) will continue to be available
by prescription for people with relapsing-remitting multiple sclerosis. As
the only non-interferon therapy for relapsing-remitting multiple sclerosis,
COPAXONE(R) plays an important role in this field of therapy and many doctors
and patients have found it an effective therapy," said Dr. Vandewalle. "We
are committed to the multiple sclerosis community, so we plan to continue
discussions with the FDA and comply with any final decision that is reached."
Teva Marion Partners has until September 15 to reply to the FDA letter.
The most commonly observed adverse reactions associated with the use of
COPAXONE(R) in clinical trials were injection site reactions (redness, pain,
inflammation, itching or a lump at the site of injection), flushing, chest
pain, weakness, infection, pain, nausea, joint pain, anxiety and muscle
stiffness. Injection site reactions were usually mild and most often did not
require professional treatment.
Some patients have reported a transient, self-limited reaction immediately
after injecting COPAXONE(R) (glatiramer acetate for injection). This reaction
is characterized by flushing or chest tightness with heart palpitations,
anxiety and difficulty in breathing. In clinical trials, these symptoms
occurred rarely, generally appeared within minutes of an injection, lasted
approximately 15 minutes and resolved without further problems.
COPAXONE(R) is the first nonsteroidal non-interferon agent indicated for use
in relapsing-remitting multiple sclerosis. Its mechanism of action is
unknown. However, it is thought to modify immune processes associated with
multiple sclerosis. Prescribing information is enclosed. Reporters who need
a comment or more information on this article over Labor Day weekend should
contact Holly Gibson at 913-722-4110 or 816-810-2977.
SOURCE Teva Marion Partners
CO: Teva Marion Partners
ST: Missouri
IN: MTC HEA
SU: