Update for June 15, 2021

​Regulatory Update
 
The FDA extended the PDUFA date for lonapegsomatropin, by three months, in order to review recently submitted information. The new target date is 9/25/2021. 
 
The FDA designated etrasimod an Orphan Drug for the treatment of eosinophilic esophagitis.
 
Announced Research Updates
 
Sanofi announced that in the 26-week, 42 patient, Phase III, CADENZA trial, 16/22 (73%) patients treated with sutimlimab achieved an increase in hemoglobin of at least 1.5 g/dL and received no transfusions or other treatment for cold agglutinin disease.
 
AstraZeneca announced that in the 80 patient, open-label, Phase II, EFFORT trial, treatment with adavosertib plus olaparib resulted in an objective response rate of 29% compared to a 23% rate with adavosertib alone in patients with poly(ADP-ribose) polymerase (PARP) inhibitor-resistant ovarian cancer.
 
Published Research Updates
 
In an 89 patient, open-label, Phase II trial, treatment with indoximod plus pembrolizumab, resulted in an overall response rate of 51% and progression-free survival of 12.4 months in patients with non-ocular melanoma. 
 
In a 56-week, 137 patient, Phase III, trial, treatment with delgocitinib reduced the mEASI score compared to placebo after the 4-week blinded phase (-39.3% vs +10.9%) and the improvement was maintained during a 52-week extension in Japanese pediatric patients with atopic dermatitis.