Active substances: Ivermectin
Received Jan 9; Accepted Apr 6.
Should it prove to have a direct effect on the malaria parasite, additional regulatory discussions would be needed and possibly be lengthy.
These early data, however, suggest that the effect is partial and thus would be a non-primary endpoint, for which label indication would not be sought. There are at least two precedents for such an intervention: Low dose primaquine as gametocytocide The use of low dose primaquine, together with a course of artemisinin-based combination therapy ACT, has been recommended by the WHO to reduce transmission in low-transmission areas via its gametocytocidal effect on Plasmodium falciparum, even in the absence of prophylactic effect or activity against asexual parasites.
The recommendation is based on its safety at the recommended dose and on the expected population benefit obtained by the transmission-blocking effect, particularly in areas threatened by artemisinin resistance.
Transmission-blocking vaccines. The outcome of that workshop and the progress achieved since have been updated recently.
From the regulatory perspective, there are many parallels between the use of a transmission-blocking vaccine and the use of ivermectin for vector control.
Here are some important conclusions that could be applicable to endectocide use in humans : Transmission-blocking vaccines are seen as potential tools for accelerating to elimination and possibly, prevent re-introduction.
There is need to standardize the assays and efficacy correlates for transmission-blocking vaccines. Key regulatory pathway points for the novel application of ivermectin What is the most appropriate regulatory agency, given the overlap between pharmaceuticals drug, vector control, and indirect impact on malaria?
Moreover, it has stated that it could rule on products not primarily intended to be marketed in the United States. It would also rule on products that would have a community effect leading to delayed personal benefit, a key obstacle for licensure for transmission-blocking vaccines.
Further discussion with both regulatory agencies by a potential sponsor would be required. Potential regulatory pathway for ivermectin for malaria vector indication If the goal is application for approval for novel use of the licensed product, then regulatory approval for drug repurposing could be sought via the 505 b 2 pathway.
The 505 b 2 has the advantage of allowing the use of evidence from studies not conducted by the sponsor, alleviating costs and reducing time to approval.
An FDA draft guidance specifically for developing treatment and prophylactic products for malaria was drafted in. For an ivermectin-based vector control tool, the best clinical trial design to demonstrate both safety as well as public health impact on malaria transmission is a pivotal cluster randomized trial with sufficient power to assess both key endpoints.
It should demonstrate added value on top of standard vector control tools, which should serve as the referent.
Note that this design was successfully utilized to definitely demonstrate the impact of other vector control tools, specifically LLINs. Please contact me for more information about topics, fees and scheduling.
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