Update for September 1, 2020

Regulatory Update
 
The FDA approved clascoterone cream (Winlevi, Cassiopea), on 8/27/2020, for the treatment of acne in patients 12 years and older. Clascoterone cream is not expected to be available until early 2021.
 
The FDA accepted the NDA for tepotinib for the treatment of metastatic non-small cell lung cancer harboring METex14 skipping alterations. 
 
The FDA notified Tricida that additional clinical data would be required to demonstrate the durability and effect of veverimer on serum bicarbonate and the applicability to patient care.
 
NewAmsterdam Pharma (NAP) acquired the rights to develop and market obicetrapib (AMG 899) from Amgen in August 2020. NAP plans to evaluate obicetrapib in a Phase III cardiovascular outcome trial in 2021.
 
The EU granted conditional approval for imlifidase as a desensitization treatment in highly sensitized kidney transplants patients.
 
Announced Research Updates
 
Novartis announced that in the 24-week, Phase III, ASCEMBL trial, treatment with asciminib produced a superior major molecular response (MMR) rate compared to bosutinib in patients with Philadelphia chromosome-positive chronic myeloid leukemia.
 
Dermavant announced that in the 12-week, 510 patient, Phase III, PSOARING 1 trial, 35.4% of patients treated with tapinarof 1% daily resulted in achievement of the Physician Assessment (PGA) scores of clear or almost clear and at least a 2-point improvement in the PGA score in 35.4% of patients compared to 6% with placebo in patients with plaque psoriasis. Dermavant also announced that in the 12-week, 515 patient, Phase III, PSOARING 2 trial, 40.2% of patients treated with tapinarof 1% daily resulted in achievement of the Physician Assessment (PGA) scores of clear or almost clear and at least a 2-point improvement in the PGA score in 35.4% of patients compared to 6.3% with placebo in patients with plaque psoriasis.
 
Akcea announced that in a 6-month, 114 patient, Phase II, dose-ranging trial, treatment with AKCEA-APOCIII-LRX lowered triglycerides up to 62% and apoC-III up to 74%, while increasing HDL by up to 42% in patients with hypertriglyceridemia who have established cardiovascular disease (CVD) or are at risk for CVD.
 
Published Research Updates
 
In an 84-day, 18 patient, Phase II trial, treatment with emixustat did not improve IL-1beta, IL-6, IL-8, TGFbeta-1, and VEGF in the aqueous humor compared to placebo in patients with proliferative diabetic retinopathy.
 
Only 17.4% of patients completed a 52-week, 161 patient, Phase III, trial evaluating sirukumab in the treatment of giant cell arteritis. Limited data suggested that fewer patients treated with sirukumab developed a flare compared to placebo.
 
In a 128 patient, Phase II trial, veliparib added to cisplatin and etoposide did not differ from only cisplatin and etoposide in patient reported neurotoxicity.