Update for November 3, 2020
The FDA accepted the NDA for Pfizer’s abrocitinib for the treatment of moderate to severe atopic dermatitis in patients 12 and older. An April PDUFA date is expected. The EMA has also accepted the MAA for abrocitinib and a decision is anticipated in the second half of 2021.
The EMA accepted the MAA for Biogen’s aducanumab for the treatment of Alzheimer’s disease.
Announced Research Updates
Kiniksa announced that in a 26-week, 70 patient, Phase II trial, 19% of patients treated with mavrilimumab experienced a giant cell arteritis flare compared to 46.4% with placebo in patients with giant cell arteritis.
Galapagos and Gilead halted enrollment in filgotinib trials for the treatment of psoriatic arthritis, ankylosing spondylitis and uveitis until after they meet with the FDA to discuss FDA concerns regarding toxicity with the higher dose (200 mg).
ChemoCentryx announced that in the 12-week, 398 patient, Phase II, AURORA trial, patients treated with neither avacopan 10 mg nor 30 mg achieved a Hidradenitis Suppurativa Clinical Response (HiSCR) compared to placebo in patients with moderate to severe Hidradenitis Suppurativa. Patients with severe disease, who were treated with avacopan 30 mg twice a day achieved a higher response than placebo.
Amryt announced that in the 3-month, 218 patient, Phase III, EASE trial, 41.3% of patients treated with oleogel-S10 had complete closure of their target wound within 45 days compared to 28.9% with placebo in patients with Epidermolysis Bullosa.
UCB announced that in the 16-week, 478 patient, Phase III, BE SURE trial, 86.2% of patients treated with bimekizumab achieved PASI 90 and 85.3% achieved an IGA score of clear or almost clear compared to 47.2% and 57.2% with adalimumab in patients with moderate-to-severe chronic plaque psoriasis.
Leo Pharma announced that in a 16-week, 258 patient, Phase IIb dose-ranging trial, patients treated with topical application of delgocitinib cream achieved an IGA score of clear or almost clear and a two point or greater improvement from baseline compared to placebo in patients with chronic hand eczema.
Regeneron announced that the Independent Data Monitoring Committee paused the open-label portion of the 28-week, 44 patient, Phase II LUMINA-1 trial in October 2020, due to fatal serious adverse events with garetosmab in the trial.
Published Research Updates
In a 48-week, 82 patient, Phase II trial, patients treated with omaveloxolone had a 1.55 point reduction in their modified Friedreich's Ataxia Rating Scale (mFARS) scores compared to a 0.85 point increase with placebo in patients with Friedreich's ataxia.
In a 61 patient, Phase II trial, administering trilaciclib before topotecan reduced the duration of severe neutropenia by five days compared to topotecan alone in patients with small cell lung cancer.
In the 12-week, 42 patient, Phase II, CLASSIC trial, avacopan added to high dose prednisone and either cyclophosphamide or rituximab did not improve the Birmingham Vasculitis Activity Score (BVAS) by at least 50% compared to placebo in patients with ANCA-associated vasculitis (AAV).
In a 12-month, 10 patient, Phase III, open-label trial, 80% of patients treated with setmelanotide achieved at least a 10% weight loss in patients with pro-opiomelanocortin deficiency obesity. In a 12-month, 11 patient, Phase III, open-label trial, 45% of patients treated with setmelanotide achieved at least a 10% weight loss in patients with leptin receptor deficiency obesity. Patients in both trials took the drug for 12 weeks and if they lost at least 5kg they went through an 8-week withdrawal period, followed by 32-weeks of open label treatment.
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