Update for October 12, 2021
The FDA approved avacopan (Tavenos, ChemoCentryx), on 10/8/2021, as adjunctive treatment of severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis (granulomatosis with polyangiitis and microscopic polyangiitis), in combination with standard therapy.
The FDA approved of allogeneic processed thymus tissue (Rethymic, Enzyvant), on 10/8/2021, as a one-time treatment of congenital athymia.
An FDA review found maribavir to be superior to investigator-assigned treatment (IAT) (ganciclovir, valganciclovir, foscarnet, or cidofovir) in clearing CMV DNA from plasma in a population of transplant patients with refractory CMV. However, the FDA felt this was primarily due to discontinuations in the IAT group.
The FDA granted an Orphan Drug Designation to posoleucel for the treatment of virus-associated hemorrhagic cystitis.
The FDA designated gantenerumab a Breakthrough Therapy for the treatment of Alzheimer’s disease.
The WHO recommends the use of the GSK malaria vaccine among children in sub-Saharan Africa and other areas heavily impacted by the disease.
The FDA designated tezepelumab an Orphan Drug for the treatment of eosinophilic esophagitis.
Announced Research Updates
Brickell announced that in the six-week, 350 patient, Phase III, Cardigan I trial, 49.3% of patients treated with sofpironium improved their Hyperhidrosis Disease Severity Measure-Axillary (HDSSM-Ax) score by at least 2 points and had a 129.5 mg decrease in their gravimetric sweat production compared to 29.4% and 99.3 mg with placebo in patients nine years of age and older with primary axillary hyperhidrosis.
Brickell announced that in the six-week, 351 patient, Phase III, Cardigan II trial, 63.9% of patients treated with sofpironium improved their HDSSM-Ax score by at least 2 points and had a 145.9 mg decrease in their gravimetric sweat production compared to 47% and 131.7 mg with placebo in patients nine years of age and older with primary axillary hyperhidrosis.
BMS announced that in the 12-week, 131 patient, Phase II, LATTICE-UC trial, treatment with deucravacitinib did not improve remission rate compared to placebo in patients with moderate to severe ulcerative colitis.
Published Research Updates
In a draft evidence report, ICER found the evidence of a health benefit for adding mavacamten to optimal treatment of heart failure promising but inconclusive compared to optimal therapy alone or adding disopyramide. Some concern was expressed for a reduction in left ventricular ejection fraction seen in some patients. Some analysts have forecast an annual cost for mavacamten of $75,000, but ICER estimated a health-benefit price benchmark (HBPB) of $12,000 to $15,000.
In a 20 patient, Phase II trial, treatment with camrelizumab plus apatinib resulted in an objective response rate of 55% in patients with high-risk chemorefractory or relapsed gestational trophoblastic neoplasia.
A 52-week, open-label extension of an unpublished 6-week, 117 patient, Phase III, blonanserin trial, found that 60 Japanese adolescents that completed the extension had a 24.9 point decrease in their PANSS score.
In the 52-week, 247 patient, Phase IIb ARREST trial, treatment with aramchol did not decrease hepatic triglycerides by magnetic resonance spectroscopy compared to placebo in patients with NASH. In a secondary endpoint analysis, treatment with aramchol lead to resolution of NASH without a worsening of fibrosis compared to placebo (16.7% vs 5%).
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