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Novartis said in a statement Friday afternoon that the reason for the current cancellation was the results of the phase III study STAND. This study showed no statistically significant difference in annual rates of vaso-occlusive crises leading to doctor visits between chrysanlizumab and placebo.
The EU Commission has to decide now, and its decision is expected in about two months. Conditional approval of the drug in the EU dates back to October 2020.
The Basel-based pharmaceutical group has expressed disappointment at the recommendation to revoke conditional approval in the EU. “However, we are aware that the STAND study does not meet one of the specific requirements for conditional approval,” the communique said. It should be noted, however, that the results of the STAND study do not raise any new safety concerns for chrysanlizumab.
According to Novartis, the results of the STAND study contradict previous results from the SUSTAIN study, which showed superiority of chrysanlizumab 5.0 mg/kg over placebo. The efficacy of crizanlizumab has also been demonstrated by data from open studies.
In sickle cell anemia, there is an increased destruction of red blood cells caused by a congenital malformation of hemoglobin, the red blood pigment. The disease is hereditary.
(SDA)
Source :Blick
I’m Tim David and I work as an author for 24 Instant News, covering the Market section. With a Bachelor’s Degree in Journalism, my mission is to provide accurate, timely and insightful news coverage that helps our readers stay informed about the latest trends in the market. My writing style is focused on making complex economic topics easy to understand for everyone.
