FDA approved one drug and added four new PDUFA Dates
The FDA approved turoctocog alfa pegol (Esperoct from Novo Nordisk) on 2/21/2019 for the treatment of hemophilia A, however due to a contractual agreement, the drug will not launch until 2020. Esperocot is a long acting version of NovoEight (turoctocog alfa).
An FDA review of selinexor found limited efficacy and significant toxicity in patients with relapsed/refractory multiple myeloma treated with a combination of selinexor dexamethasone. Based on data submitted and historical studies with high-dose dexamethasone, the FDA felt it was difficult to isolate the treatment effect of selinexor. The FDA's Oncologic Drugs Advisory Committee will review selinexor on 2/26/2019.
New PDUFA dates
In the 1,509 patient, Phase III ARAMIS trial, the most common ADR with darolutamide compared to placebo was fatigue.
Reata announced that in the 12-week, 103 patient, Phase II, open-label, PHOENIX study, patients treated with bardoxolone had an increase in their mean estimated glomerular filtration rate (eGFR) from of 7.8 mL/min/1.73 m2 improvement in patients with patients with autosomal dominant polycystic kidney disease, IgA nephropathy, Focal Segmental Glomerulosclerosis, and type 1 diabetic chronic kidney disease.
Alder submitted a BLA for eptinezumab in February 2019.
Vanda is suing the FDA to lift the partial hold on tradipitant clinical trials.
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