Impavido Gets Big Thumbs Up, Weighed Down By Dosing Concern
This article was originally published in The Pink Sheet Daily
Anti-Infective Drugs Advisory Committee votes to recommend approval of leishmaniasis treatment, but questions about a post-marketing study on dosing in heavier patients linger.
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FDA reviewers did not identify any major problems with the application for treatment of three types of leishmaniasis, but did say the product may face resistance problems as use expands.
Approval of the leishmaniasis treatment by its December user fee date would give the Canadian sponsor a voucher for a priority review, which it is likely to sell to another company.
CBER director does not want to hold back potentially beneficial products, but also warned that patients will have difficult treatment decisions to make since an immune response might prevent a patient from receiving another gene therapy using the same vector ever again.