Prometic Receives Rare Pediatric Disease Designation
Prometic Life Sciences announced the US Food and Drug Administration granted a Rare Pediatric Disease Designation to Prometic’s Ryplazimä.
Prometic Life Sciences (TSX:PLI; OTCQX:PFSCF) announced the US Food and Drug Administration (FDA) granted a Rare Pediatric Disease Designation to Prometic’s Ryplazimä.
As quoted in the press release:
In addition to the Rare Pediatric Disease Designation, Ryplazimä has already been granted Orphan Drug and Fast Track Designation by the FDA.
The FDA grants Rare Pediatric Disease Designation for serious or life-threatening diseases in which the serious or life-threatening manifestations primarily affect individuals aged from birth to 18 years, including age groups often called neonates, infants, children, and adolescents. If approved, Prometic’s plasminogen replacement therapy will be eligible to receive a rare pediatric disease priority review voucher.
Click here to read the full press release.
Source: www.newswire.ca
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