US gene therapy company, Avexis, recently announced that it has met with FDA officials and received constructive feedback about its AVXS-101 development programme for SMA type 1. The company plans to initiate a single-arm phase 1 study in the first half of 2017. There will not be a placebo group in this study so the resulting data will be compared against natural history data.
The FDA requested to be briefed on the results once the study is completed: “We strongly recommend that at the completion of the study, you request an end-of-Phase 1 meeting to evaluate the adequacy of data to support future product development, including a discussion of whether the data from the Phase 1 study might provide the substantial evidence necessary to support a marketing application.”
For more information, read Avexis http://investors.avexis.com/phoenix.zhtml?c=254285&p=irol-newsArticle&ID=2218102
http://www.musculardystrophyuk.org/news/breaking-research-news/
The FDA requested to be briefed on the results once the study is completed: “We strongly recommend that at the completion of the study, you request an end-of-Phase 1 meeting to evaluate the adequacy of data to support future product development, including a discussion of whether the data from the Phase 1 study might provide the substantial evidence necessary to support a marketing application.”
For more information, read Avexis http://investors.avexis.com/phoenix.zhtml?c=254285&p=irol-newsArticle&ID=2218102
http://www.musculardystrophyuk.org/news/breaking-research-news/
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