Catalyst Bio Gets Orphan Drug Designation for MarzAA to Treat Factor VII Deficiency
September 28 2021 - 4:58PM
Dow Jones News
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.
Write to Stephen Nakrosis at stephen.nakrosis@wsj.com
(END) Dow Jones Newswires
September 28, 2021 16:43 ET (20:43 GMT)
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