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Genzyme Wins Approval for Leukemia Drug
Posted on 2004-12-29 15:44:00
Genzyme Corp. won approval Wednesday for a childhood leukemia drug under an accelerated government approval process for potentially lifesaving treatments. The drug Clolar won Food and Drug Administration approval to treat patients aged 1 to 21 who have exhausted other treatment options for acute lymphoblastic leukemia. The medication is the first new leukemia treatment cleared specifically for pediatric use in more than a decade, Cambridge-based Genzyme said.
The FDA granted Clolar orphan drug status, which provides seven years of market exclusivity for treating pediatric cases of the most common form of childhood leukemia.The drug was approved under the FDA's accelerated approval process for products that may offer improvements over existing therapies for serious or life-threatening diseases. Such approvals require studies after a drug's approval to verify clinical benefits.
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