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Review Of Reviews: Drug Review Profiles 2014

Executive Summary

Pharmaceutical Approvals Monthly’s Drug Review Profile stories from 2014.

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FDA Quietly Consults Patients To Understand Six-Minute Walk Significance

Meeting with Morquio A patient and caregivers appears to have helped to assuage FDA concerns about clinical relevance of the Vimizim trial’s primary endpoint – and illustrates FDA’s openness to patient input even during specific reviews of new product applications.

FDA Awaits Data On Clinical Significance Of Vimizim Neutralizing Antibodies

Vimizim post-marketing requirements could help FDA better understand the clinical significance of anti-drug antibodies commonly seen with enzyme replacement therapies for lysosomal storage diseases and the risks of tolerance induction therapy to manage immunogenicity.

In Manufacturing, Absence Of Evidence Is Not Evidence Of Absence, FDA Tells BioMarin

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.

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