Update for May 12, 2021
Hutchmed completed a rolling NDA for surufatinib as a treatment of pancreatic and extra-pancreatic neuroendocrine tumors.
An FDA review of avacopan questioned whether data supported efficacy, because it was difficult to determine if the beneficial effect was caused by avacopan or rituximab/cyclophosphamide. The FDA also felt there was not enough historical data on the effects of prednisone to justify a non-inferiority trial design. The FDA’s Arthritis Advisory Committee voted 10 to 8 to recommend approval of ChemoCentryx’s avacopan to treat anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis. The committee was split 9 to 9 on whether efficacy data supported approval and 10 to 8 on whether the safety profile supported approval.
Amgen submitted a BLA for tezepelumab for the treatment of severe asthma.
Announced Research Updates
Bayer announced that in the 53-month, 7,437 patient, Phase III, FIGARO-DKD trial, treatment with finerenone reduced the composite endpoint of time to first occurrence of cardiovascular death or non-fatal CV events (myocardial infarction, stroke, or hospitalization for heart failure) compared to placebo in type 2 diabetics with chronic kidney disease.
AstraZeneca announced preliminary results from the 1,013 patient, Phase III, open-label, POSEIDON trial, PFS and OS were both improved with durvalumab, tremelimumab and platinum-based chemotherapy, while durvalumab plus platinum-based chemotherapy only improved PFS compared to platinum-based chemotherapy alone as first line treatment in patients with metastatic non-small cell lung cancer without epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) fusions.
Orphazyme announced that in the 76-week, 245 patient, Phase III, ORARIALS-01 trial, treatment with arimoclomol did not improve the combined assessment of function and survival (CAFS) score compared to placebo in patients with amyotrophic lateral sclerosis.
Published Research Updates
In the 318 patient, Phase III, ALLEVIATE trial, a greater percentage of patients treated with reproxalap 0.25% and 0.5% ophthalmic solutions reduced the ocular itch score within 10 to 60 minutes after allergen challenge compared to placebo in patients with seasonal allergic conjunctivitis.
In a 12-week, 27 patient, Phase II, open-label trial, 52% of patients treated with rilzabrutinib Achieved Control of Disease Activity (no new lesions, existing lesions healing) at 4-weeks in patients with pemphigus foliaceus.
In a draft evidence report for aducanumab, ICER found the evidence to be insufficient to support efficacy and estimates a cost-effective range of $2,500 to $8,300 per year.
In the 378 patient, extension of the Phase II, FORWARD trial, patients treated with sprifermin maintained the 0.05 mm increase in femorotibial joint cartilage thickness compared to placebo at five years. Overall, there was no improvement in WOMAC score compared to placebo, however, no patient in the 100 mcg group required knee replacement. In a subgroup of 161 patients at risk for progression, a decrease in the WOMAC score was maintained through year five.
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