Cybertom schreef op 23 februari 2018 11:11:
By Carlo Martuscelli
Shire PLC (SHP.LN) said Friday that the U.S. Food and Drug Administration has accepted its application for its lanadelumab drug, and granted it priority review.
The pharmaceutical company said that its license application is backed by data from its phase 3 study which showed that lanadelumab--a drug for the treatment hereditary angioedema--was able to reduce the severity of symptoms in patients who were given the drug.
The FDA's priority review status shortens the government body's review target to eight months from a year. It's expected to make a decision on the drug by Aug. 26, Shire said. If approved, Shire will be able to bring the drug to market.
Hereditary angioedema is a rare genetic disorder that causes recurrent swelling and pain. Some attacks can cause asphyxiation, and are potentially life-threatening.
Write to Carlo Martuscelli at
carlo.martuscelli@dowjones.com(END) Dow Jones Newswires
February 23, 2018 05:09 ET (10:09 GMT)
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