Posted by Michael Wonder on 22 Sep 2016
SANARIA® PfSPZ VACCINE AGAINST MALARIA RECEIVES FDA FAST TRACK DESIGNATION
22 September 2016 - Sanaria Inc. today announced it has received U.S. FDA Fast Track designation for its preventative vaccine for malaria, Sanaria PfSPZ Vaccine.
Sanaria believes its PfSPZ Vaccine is the only malaria vaccine to have ever received this distinction.
According to the FDA, “Fast Track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier.” A drug (or vaccine) that receives Fast Track designation is eligible for Accelerated Approval and Priority Review, which can considerably speed the time to market.
Sanaria® PfSPZ Vaccine is in clinical trials in subjects ranging in age from 6-month old infants to adults in the U.S., Europe and Africa. These trials are intended to finalize an immunization regimen to be taken forward into pivotal phase 3 clinical trials that will, if successful, provide the necessary data for licensing the vaccine.
