Amplitude Healthcare Target Jasper Gets Key FDA Designations
By Colin Kellaher
Jasper Therapeutics Inc., which recently agreed to combine with
blank-check company Amplitude Healthcare Acquisition Corp., on
Monday said the U.S. Food and Drug Administration granted a pair of
key designations to JSP191, its lead compound.
The Redwood City, Calif., biotechnology company said the FDA
granted JSP191 orphan-drug designation for conditioning treatment
prior to hematopoietic stem cell transplantation and
rare-pediatric-disease designation as a conditioning treatment for
patients with severe combined immunodeficiency, a life-threatening
genetic illness that is typically fatal within two years without
hematopoietic cell transplantation.
The FDA's orphan-drug program gives special status to drugs and
biologics for diseases and disorders that affect fewer than 200,000
people in the U.S. and provides for an extended marketing
exclusivity period against competition.
The agency's rare-pediatric-disease designation covers diseases
with serious or life-threatening manifestations that mainly affect
fewer than 200,000 people in the U.S. under the age of 18. The FDA
awards priority-review vouchers to drug makers upon approval of
drugs that are granted the designation, and those vouchers can be
used to obtain priority review for another drug or sold to other
Amgen Inc. discovered JSP191 and licensed the worldwide rights
to the monoclonal antibody to Jasper.
Write to Colin Kellaher at email@example.com
(END) Dow Jones Newswires
June 14, 2021 09:26 ET (13:26 GMT)
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