Biomatrix Inc. announced that it has filed a product licenseapplication (PLA) in the United Kingdom to market Synvisc, itshylan product for treating osteoarthritis, in the EuropeanCommunity (EC). The United Kingdom will serve as rapporteurin obtaining approval in the other EC countries.
Clinical trial data in the European PLA include reports frommore than 1,400 knee joint injections of Synvisc, which is achemically modified version of the naturally occurringsubstance hyaluron that acts as a lubricant and shock absorberin joints. Biomatrix already has permission to market theproduct in Canada as a "short-term implant or substance," saidEndre Balazs, chief executive officer of the Ridgefield, N.J.,company (NASDAQ:BIOX). Moreover, Biomatrix has justcompleted clinical trials of the compound in the U.S. on 80 to100 patients, and intends to file a PMA in the first quarter of1993, Balasz said.
Synvisc treatment involves a series of injections -- usuallythree injections one week apart -- into the affected arthriticjoint. The series of injections is considered a completetreatment for that incidence of pain, and the product labelrecommends that it not be repeated for at least four weeks,Balazs told BioWorld.
The trials have included some long-term follow-up studies,from six months to more than a year. "It's the only treatmentknown thus far that extends the period after injection exceptcorticosteroids," Balazs said. "Compared to analgesics and non-steroidal anti-inflammatory drugs, Synvisc produces a long-term effect."
-- Jennifer Van Brunt Senior Editor
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