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 companies.

Amgen Inc. discovered JSP191 and licensed the worldwide rights to the monoclonal antibody to Jasper.

 

Write to Colin Kellaher at colin.kellaher@wsj.com

 

(END) Dow Jones Newswires

June 14, 2021 09:26 ET (13:26 GMT)

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