2023-05-12 07:00:00
Ultomiri approved in Europe
L’Ultomiris (ravulizumab) d’AstraZeneca has been approved in Europe for the treatment of adults with neuromyelitis optica spectrum disorder (NMOSD), a rare and debilitating autoimmune disease that affects the central nervous system, including the spine and optic nerves. Authorization requests are in progress in the United States and Japan. This drug joined the laboratory’s pipeline with the acquisition of Alexion in 2021.
EMA clears CAR-T therapy from BMS
Bristol Myers Squibb (BMS) has received approval from the European Commission for its Breyanzi (lisocabtagene maraleucel) for relapsed or refractory large B-cell lymphoma following previous treatment. In Phase III, this drug significantly improved survival compared to standard standard of care. This is the third indication obtained in Europe for a CAR-T cell therapy from the American laboratory.
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European green light for Servier
The European Commission has just issued an MA to Tibsovo (ivosidenib) of servant in two directions. The first concerns acute myeloid leukemia (AML), a cancer of the blood and bone marrow which affects 5 out of 100,000 people in Europe. The second targets cholangiocarcinoma with a mutation in the IDH1 gene, a cancer of the bile ducts which affects 1 to 3 people in 100,000 in Europe, with approximately 10,000 new cases each year.
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