- In June 2023, GSK has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), recommending the authorization of daprodustat for the treatment of symptomatic anemia associated with chronic kidney disease (CKD) in adults undergoing chronic maintenance dialysis. This recommendation marks a significant step towards providing a new therapeutic option for managing anemia in CKD patients on long-term dialysis, addressing an important unmet medical need in this population
- In March 2024, Vafseo approved by the U.S. FDA for the treatment of anemia due to chronic kidney disease in dialysis-dependent adult patients. CSL Vifor is pleased that its partner Akebia Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Vafseo (vadadustat) tablets for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months. Vafseo is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) developed by Akebia
- In February 2024, Lupin launched a Cyanocobalamin Nasal Spray, 500 mcg/spray (One Spray per Device), after having received an approval from the United States Food and Drug Administration (U.S. FDA)
- In December 2023, Novartis receives FDA approval for Fabhalta (iptacopan), offering superior hemoglobin improvement in the absence of transfusions as the first oral monotherapy for adults with PNH 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). 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 March 2024, Ferinject approved by Health Canada for the treatment of iron deficiency anemia in adult and pediatric patients and iron deficiency in adult patients with heart failure announced that Health Canada has authorized Ferinject (ferric carboxymaltose) for the intravenous (IV) treatment of iron deficiency anemia in adult and pediatric patients one year of age and older when oral iron preparations are not tolerated or are ineffective, as well as for the treatment of iron deficiency in adult patients with heart failure
