Roche Gets EU Approval for Blood Disorder Injection PiaSky
By Ian Walker
Roche Holding said that the European Commission has approved blood disorder injection PiaSky.
The Swiss pharmaceutical giant said Tuesday that the approval follows a Phase III study which showed that PiaSky achieved disease control for a rare blood disorder known as paroxysmal nocturnal haemoglobinuria and was well tolerated when administered every four weeks via subcutaneous injection.
PiaSky is a recycling monoclonal antibody that inhibits the complement protein C5 and is designed to block the complement system, a part of the innate immune system that acts as the body's first line of defense against infection.
Paroxysmal nocturnal haemoglobinuria is a rare and life-threatening blood condition where red blood cells are destroyed by the complement system causing anaemia, fatigue and blood clots, and potentially leading to kidney disease.
Write to Ian Walker at ian.walker@wsj.com
(END) Dow Jones Newswires
August 27, 2024 01:44 ET (05:44 GMT)
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