Update on investigational drugs with recent and upcoming PDUFA dates:
In a Phase II trial, bimagrumab (Novartis) treated patients with sporadic inclusion body myositis had an increase in thigh muscle volume, but not 6-minute walk distance. Bimagrumab has a Breakthrough Therapy Priority Designation.
Patients with rheumatoid arthritis that had achieved sustained control with 4 mg baricitinib (Lilly, Incyte) when given a reduced dose of 2mg showed a low disease activity rate in 67% vs 80%, remission in 33% vs 40%, relapse in 37% vs 23% and need for rescue medication in 18% vs 10%.
In a Phase III trial, postmenopausal women were treated with romosozumab (Amgen, UCB) or placebo for 1 year, then denosumab for 2 years. After 36 months 1% of romosozumab patients had a vertebral fracture compared to 2.8% with placebo. In another Phase III trial, patients were treated with either romosozumab or alendronate for one year, then all patients received alendronate for an additional year. After 24 months. romosozumab patients had an incidence of vertebral and clinical fractures of 6.2% and 9.7% compared to alendronate patients’ incidence of 11.9% and 13%. In a complicated extension trial with multiple treatment combinations, there was evidence to suggest further increase in BMD, in patients that received 12 months of denosumab after receiving 24 months of romosozumab. In a 245 male patient, Phase III trial, romosozumab increased BMD in the spine and hip compared to placebo in men with osteoporosis.
In a Phase III trial, more patients with moderate-to-severe rheumatoid arthritis treated with filgotinib (Galapagos, Gilead) 200 mg achieved AR20 (69 vs 55%), AR50 (46 vs 35%) and AR70 (32 vs 20%) vs placebo.
In a 12-week, dose ranging, Phase II trial, of patients with moderate-to-severe psoriasis, treatment with daily doses of BMS-986165 resulted in lower Psoriasis Area and Severity Index score than placebo.
Multiple updates for risankizumab (AbbVie, Boehringer Ingelheim):
Colucid announced a study of 1,545 migraine patients, in which 28-32% of patients treated with lasmiditan were migraine pain-free at 2 hours compared to 15% with placebo and 41% had resolution of their most bothersome symptoms vs 30% with placebo.
Lilly announced that in a Phase III trial, 31-39% of patients with an acute migraine treated with lasmiditan were pain-free at 2 hours compared to 21% with placebo. 44-49% of lasmiditan patients were free of their most bothersome symptoms at 2 hours.
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