Update for February 8, 2023

Regulatory Update
 
The FDA approved daprodustat (Jesduvroq, GSK), on 2/1/2023, to treat anemia in chronic kidney disease patients on dialysis. Daprodustat was approved with a boxed warning of the increased risk of increased risk of death, myocardial infarction, stroke, venous thromboembolism, and thrombosis of vascular access. 
 
The FDA accepted the NDA for zuranolone for the treatment of major depressive disorder and postpartum depression and set a PDUFA date for 8/5/2023.
 
Mesoblast resubmitted a BLA for remestemcel-L to treat pediatric steroid-refractory acute graft versus host disease.
 
Roche discontinued development of ipatasertib and gantenerumab due to lack of efficacy.
 
In February 2023, Vistagen proposed changes to the PALISADE-2 study protocol to the FDA. Vistagen is also designing a new Phase III trial that would include multiple doses of PH94B and use the the Liebowitz Social Anxiety Scale (LSAS) as the primary endpoint. The outcome of a meeting with the FDA will determine when the PALISADE-2 trial would be restarted.
 
Announced Research Updates
 
Roche announced that in the 25-week, 200 patient, open-label, Phase III COMMODORE 2 trial, treatment with crovalimab was non-inferior to eculizumab in achievement of an LDH of 1.5 or less of the upper limit of normal and being RBC transfusion free in non-U.S. patients with PNH who have not been previously treated with complement inhibitors.
 
Published Research Updates
 
In a 96-week, 453 patient, Phase II trial, treatment with tilavonemab did not improve the Clinical Dementia Rating-Sum of Boxes score compared to placebo in patients with early Alzheimer's disease.