Update for August 31, 2021

Regulatory Update 

The FDA approved lonapegsomatropin (Skytrofa, Ascendis Pharma), on 8/25/2021, for the treatment of inadequate secretion of endogenous growth hormone in patients one year and older who weigh at least 11.5 kg (25.4 lb).
 
The FDA accepted the NDA for asciminib for the treatment of chronic myeloid leukemia and set a PDUFA date for 4/25/2021.
 
The EMA approved bimekizumab for the treatment of moderate to severe plaque psoriasis.
 
Announced Research Updates
 
Pfizer announced that in the 26-week, 728 patient, Phase III, JADE DARE trial, more patients treated with abrocitinib 200 mg achieved at least a 4-point improvement in the severity of Peak Pruritus Numerical Rating Scale (PP-NRS4) and EASI-90 at 4-weeks compared to dupilumab in patients with moderate to severe AD who were also on background topical therapy. 
 
Published Research Updates
 
In the 12-week, 873 patient, Phase III, ADVANCE trial, monthly migraine days were reduced by 3.7 days with atogepant 10 mg, 3.9 days with 30 mg, and 4.2 days with 60 mg compared to a 2.5 days decrease with placebo in patients with 4 to 14 migraine days per month. 
 
In a 140 patient, Phase II trial, treatment with balstilimab resulted in a 15% ORR in patients with recurrent and/or metastatic cervical cancer, who had relapsed after a prior platinum-based treatment.
 
In a 970 patient, Phase II trial, adding veliparib to carboplatin and paclitaxel did not improve OS compared to carboplatin and paclitaxel alone (5.8 vs 5.6 months) in 553 patients who smoke and have untreated, advanced squamous non-small-cell lung cancer.  In the overall population adding veliparib improved OS (12.2 versus 11.2 months), but did not improve PFS (5.6 months in both arms).
 
In a 122 patient, Phase II trial, treatment with spartalizumab did not improve progression-free survival compared to investigator’s choice of chemotherapy (1.9 versus 6.6 months) in patients with refractory, recurrent/metastatic nasopharyngeal cancer who had progressed after a prior platinum-based chemotherapy.
 
In the 3.4 year, 7,437 patient, Phase III, FIGARO-DKD trial, 12.4% of patients treated with finerenone experienced the composite endpoint of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure compared to 14.2% with placebo in type 2 diabetics and stage 2 to 4 chronic kidney disease. The benefit with finerenone was primarily from a lower incidence of hospitalization for heart failure.