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Home Industry News Genzyme announces enrolment in Fabrazyme post-marketing study

Genzyme announces enrolment in Fabrazyme post-marketing study

16th October 2008

Genzyme has announced it has begun enrolment in a global post marketing clinical trial to evaluate the efficacy and safety of treating paediatric male patients suffering from mild Fabry disease symptoms with a regimen of Fabrazyme (agalsidase beta).

Data gleaned from the study could well support supplemental submissions to regulatory agencies in search of additional dosing options which facilitate early treatment for the condition, the company states.

The study is entitled Fabrazyme: Intervening Early at a Lower Dose (Field).

Dr Uma Ramaswami, metabolic paediatrician at Addenbrooke’s Hospital in Cambridge and co-principal investigator for the research, said the treatment scheme might be adapted for patients with milder symptoms of the condition, giving them flexibility in their treatment options.

“The ability to provide a lower or less frequent dose of Fabrazyme for paediatric patients with milder symptoms may translate to some patients receiving the treatment early,” she adds.

As many as 20 institutions from across Europe, Canada, Latin America and the USA are expected to take part in the study, which will involve participants between the ages of five and 18.

In recent days, Genzyme announced it had been named a top employer in a survey commission by the publication Science.

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