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Genzyme seeks OK on osteoarthritis drug
CAMBRIDGE, Mass., June 20 (UPI)
Genzyme said Wednesday it has filed for U.S. approval of Synvisc-One, a
treatment used once every six months to treat osteoarthritis pain in
the knee.
The company said that, if approved, its injectable drug would be the
first to provide six months' pain relief in a single treatment.
Genzyme said it expects the Food and Drug Administration to take action on its application by the end of the year.
"The submission for approval of Synvisc-One is based on
positive data which demonstrated that combining three doses of Synvisc
in a single treatment is safe and effective in providing pain relief
for up to six months in patients with knee osteoarthritis," said Ann
Merrifield, president of Genzyme Biosurgery.
Genzyme's current Synvisc dosage form is delivered via
three intra-articular doses of 2 milliliters each, administered at
one-week intervals. Synvisc-One combines the three doses into one 6
milliliter injection.
SOURCE: The European League Against Rheumatism
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