PaxMedica announces request from MOH for emergency access to IV suramin

PaxMedica announced it has received an urgent request from the Ministry of Health, or MOH, of Malawi, asking for emergency access to IV suramin to avert a potential humanitarian crisis brought on by dwindling supplies of drugs used routinely to save lives in that region of Africa. PaxMedica, which just last week announced that it has completed execution of its three pivotal registration/validation batches of PAX-101, an IV form of suramin, has brought this emergency request to the attention of the FDA to determine potential impact, if any, on the ongoing development program and NDA submission plans for PAX-101. PaxMedica has previously announced the completion of its recent Type B meeting with FDA in preparation for submitting an NDA for the use of PAX-101 in the treatment of the rare and fatal trypanosomal infection, Trypanosoma brucei rhodesiense, caused by the bite of a tsetse fly. The company said, “PaxMedica is in the process of responding to the Malawi Ministry of Health’s request and is in contact with regulatory authorities in both the U.S. and Malawi with an intention to help with today’s emergency, as well as to work with the FDA to determine the best path forward to submit the PAX-101 NDA for regulatory approval, as well as to potentially qualify for a Priority Review Voucher under the Neglected Tropical Disease Priority Review Voucher Program, which could provide PaxMedica resources to help ensure a steady supply of suramin to these endemic regions.”