Novartis (NVS) obtains FDA approval for Fabhalta, the first oral monotherapy for treating adults with PNH.
Novartis today announced that the U.S. Food and Drug Administration (FDA) approved Fabhalta® (iptacopan) as the first oral monotherapy for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH)1. Fabhalta is a Factor B inhibitor that acts proximally in the alternative complement pathway of the immune system, providing comprehensive control of red blood cell (RBC) destruction within and outside the blood vessels (intra- and extravascular hemolysis [IVH and EVH]). In clinical trial
Merck KGaA's experimental multiple sclerosis (MS) drug missed the primary goal in highly anticipated late-stage trials, dealing a major blow to the German company's growth ambitions and hitting its shares. In two Phase III trials, the compound known as evobrutinib failed to beat Sanofi's established Aubagio in reducing MS relapse rates, Merck said in a statement late on Tuesday. Merck was seen as ahead of Sanofi, Novartis and Roche in a four-way race to develop more targeted MS drugs in a class known as Bruton’s tyrosine kinase (BTK) inhibitors.