US FDA approves Roche's drug for a chronic blood disorder
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[June 22, 2024]
(Reuters) - The U.S. Food and Drug Administration on Thursday
approved Roche's drug for a chronic blood disorder, the Swiss drugmaker
said.
The drug crovalimab, branded as PiaSky, is a monthly under-the-skin or
intravenous treatment for paroxysmal nocturnal hemoglobinuria (PNH).
PNH is a disorder in which red blood cells break apart prematurely. It
can cause anemia, fatigue and blood clots, and can lead to kidney
disease.
Roche said the disease affects around 20,000 people worldwide.
The approval is based on a late-stage study in which PiaSky showed a
79.3% control in the destruction of red blood cells versus 79% for the
standard-of-care eculizumab from week 5 to week 25.
"Crovalimab could provide an option to self-administer as infrequently
as every four weeks, thereby reducing clinic visits for people with this
lifelong condition," said Levi Garraway, chief medical officer of Roche.
Other treatments for PNH such as Astrazeneca's Ultomiris and eculizumab,
sold as Soliris, and Amgen's Bkemv require infusion by healthcare
professionals.
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The logo of Swiss pharmaceutical company Roche is seen at a plant in
the central Swiss village of Rotkreuz November 6, 2013. REUTERS/Arnd
Wiegmann/File Photo
 PiaSky was approved in China in
February and Japan in March.
The drug is also being tested in two other blood disorders, atypical
hemolytic uremic syndrome and sickle cell disease, and a kidney
disease called lupus nephritis.
(Reporting by Puyaan Singh in Bengaluru; Editing by Vijay Kishore)
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