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.
You may also be interested in...
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.
In an interview, OND Deputy Director of Operations Kevin Bugin describes how FDA might be able to "accelerate" the transition back to in-person meetings if the initial phase with Type A and BPD Type 1 meetings goes well. But there is still no plan to return to in-person advisory committees.