Roche gets USFDA nod for chronic blood disorder treatment Crovalimab
Roche has received approval from the U.S. Food and Drug Administration (USFDA) for Crovalimab for the treatment of chronic blood disorder.
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, according to a Reuters report.
"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.
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.
Medical Dialogues had earlier reported that Roche has launched the clinically approved, highly-sensitive in-situ hybridisation (ISH) test, the VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail assay, in countries accepting the CE Mark. The test is designed to help pathologists differentiate a B-cell malignancy from a normal, reactive response to an infection.
Read also: Roche unveils new highly-sensitive B-cell lymphoma test
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