AstraZeneca: FDA Gives Orphan Drug Status to Two Liver Cancer Drugs
January 20 2020 - 2:48AM
Dow Jones News
By Carlo Martuscelli
AstraZeneca PLC (AZN.LN) said Monday that two of its medicines
were granted orphan drug status by the U.S. Food and Drug
Administration for the treatment of a common type of liver
cancer.
The designation is awarded to drugs that are intended to treat
rare disease and provides benefits such as market exclusivity and
faster regulatory approvals.
Imfinzi and tremelimumab were given orphan drug status as
treatments for hepatocellular carcinoma, or HCC. Imfinzi is already
approved for other types of cancer, while tremelimumab is currently
being investigated as a potential treatment.
The two drugs are being jointly studied in the phase 3 Himalaya
clinical trial as treatments for a type of inoperable and advanced
HCC.
Write to Carlo Martuscelli at carlo.martuscelli@wsj.com;
@carlomartu
(END) Dow Jones Newswires
January 20, 2020 02:33 ET (07:33 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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