Good News For A Change At Genzyme: Consent Decree Finalized Without Surprises, Lumizyme Approved By FDA Ahead Of Schedule
Belying the adage that no news is good news, embattled Genzyme enjoyed two measures of positive news in the past week. But activist investors continue circling the company, which is not yet out of the deep water
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BioMarin showed that the Vimizim BLA did not have enough data to prove that clinical and commercial sites are different. That’s not the same as concluding there is no difference between the sites, FDA said.
Changes in the manufacturing site and production scale for exenatide extended-release complicated FDA’s review of Bydureon, Amylin’s follow-on agent to Byetta, and late-rising questions about the drug’s QT effects made FDA revisit its earlier conclusion that the investigational and commercial formulations were comparable. The agency’s decision to require additional clinical data in a second “complete response” letter suggests biosimilar sponsors will face a similarly high clinical hurdle.
The orphan drug, for a rare blood disorder, is the latest in a history of drugs for ultra-orphan conditions.