Ad hoc announcement pursuant to Art. 53 LR Approval based on APPLY-PNH trial in adults with PNH and anemia despite prior anti-C5 treatment, and supported by the APPOINT-PNH study in complement inhibitor-naïve patients1-5 In APPLY-PNH, patients who switched to Fabhalta experienced superior increases of hemoglobin levels ≥ 2 g/dL (82.3% vs. 0%) and hemoglobin level ≥ 12 g/dL (67.7% vs. 0%), both in the absence of red blood cell transfusions, vs. patients who continued on anti-C5 treatment1,2 Fabha
Germany's Merck KGaA said its experimental multiple sclerosis drug evobrutinib did not meet the primary goal in highly anticipated late-stage trials, dealing a major blow to the company's growth ambitions. In the Phase III trials, evobrutinib failed to reduce the annualized relapse rate compared to Sanofi's Aubagio in patients with relapsing multiple sclerosis, Merck said in a statement 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.
Private equity firm Blackstone is exploring the sale of Anthos Therapeutics, a developer of a new generation of blood thinners it launched four years ago with backing from Novartis, according to people familiar with the matter. Anthos, which does not yet have any approved products or generate revenue, could be worth several billion dollars in a potential sale, significantly more than the $250 million Blackstone invested when it founded Anthos in 2019, the sources said. Cambridge, Massachusetts-based Anthos' most advanced product, a monoclonal antibody called abelacimab, is intended for patients with atrial fibrillation who do not respond well to other anticoagulants because of heavy bleeding.