By Stephen Nakrosis


Catalyst Biosciences Inc. on Tuesday said its lead product candidate, subcutaneous Marzeptacog alfa (activated), received orphan drug designation from the U.S. Food and Drug Administration for the treatment of Factor VII Deficiency, a type of hemophilia.

The company said the product, also called MarzAA, previously received orphan drug designation and fast track designation to treat hemophilia A/B with inhibitors and fast-track designation for the treatment of Factor VII Deficiency.

The FDA grants orphan drug status to treatments for rare diseases and the designation qualifies the sponsor of the drug for various development incentives, including tax credits for qualified clinical testing.

"Receiving a second orphan drug designation in addition to two FTDs for MarzAA demonstrates its potential in treating multiple rare bleeding disorders," said Nassim Usman, president and chief executive of Catalyst.


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(END) Dow Jones Newswires

September 28, 2021 16:43 ET (20:43 GMT)

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