The FDA canceled a May advisory committee meeting when questions arose regarding the Viaskin Peanut patch’s adhesion and efficacy if the patch is not fully adhered. Aimmune is in the process of providing data on the question. The PDFUA date has not been changed.
Mallinckrodt completed a rolling NDA for terlipressin for the treatment of patients with hepatorenal syndrome type 1 in March 2020.
Canada approved cabotegravir and rilpivirine injection for the treatment of HIV-1 infection.
Announced Research Updates
Merck announced that in the 12-week, 732 patient, Phase III, COUGH-1 trial, treatment with gefapixant 45 mg BID reduced the 24-hour coughs per hour average more than placebo in patients with refractory or unexplained chronic cough. Merck announced that in the 24-week, 1,317 patient, Phase III, COUGH-2 trial, treatment with gefapixant 45 mg BID reduced the 24-hour coughs per hour average more than placebo in patients with refractory or unexplained chronic cough. Treatment with gefapixant 15 mg BID did not differ from placebo in both the COUGH-1 and COUGH-2 trials.
Pfizer announced that in a 16-week, 837 patient, Phase III, JADE COMPARE trial, more patients treated with abrocitinib 100 mg and 200 mg achieved an IGA score of clear or almost clear skin, had a 2 point or > improvement in their IGA score and had more patients achieve at least a 75% or greater improvement in their Eczema Area and Severity Index (EASI) score compared to placebo in patients with moderate to severe atopic dermatitis receiving topical therapy. Pfizer plans to submit an NDA for abrocitinib by the end of 2020.
AstraZeneca announced that in the 805 patient, Phase III, open-label, CASPIAN trial, the addition of tremelimumab to durvalumab plus standard-of-care chemotherapy did not improve overall survival compared to durvalumab plus standard-of-care chemotherapy in patients with extensive-stage small cell lung cancer.
Published Research Updates
In a 52 patient, Phase II trial, treatment with rivoceranib and carboplatin-paclitaxel as first-line chemotherapy demonstrated an ORR of 64.3% compared to 33.3% with rivoceranib and concurrent chemo-brachytherapy in patients with recurrent and advanced cervical cancer.
A subgroup analysis of 8,236 diabetic patients enrolled in the 6-month, Phase III, ACCELERATE trial, found that treatment with evacetrapib increased HDL by 131% and lowered LDL by 32%. HbA1c was lower than placebo (7.08% vs 7.15%), but there was no difference in the primary composite endpoint of cardiovascular death, myocardial infarction, stroke, revascularization, and hospitalization for unstable angina compared to placebo.
In the 510-day, 482 patient, Phase III, ORION-9 trial, treatment with inclisiran lowered LDL by 39.7% compared to an 8.2% increase with placebo in patients with heterozygous familial hypercholesterolemia. In the 510-day, 1,561 patient, Phase III, ORION-10 trial, the placebo adjusted reduction in LDL with inclisiran was 52.3% in patients with atherosclerotic cardiovascular disease and elevated LDL despite maximum tolerated dose of statin. In the 510-day, 1,617 patient, Phase III, ORION-11 trial, the placebo adjusted reduction in LDL with inclisiran was 49.9% in patients with atherosclerotic cardiovascular disease or risk equivalents and elevated LDL despite maximum tolerated dose of statin.
In a 71 patient, Phase II trial, treatment with Lu-PSMA-617 plus dexamethasone did not improve PSA compared to Lu-PSMA-617 monotherapy in patients with metastatic castration-resistant prostate cancer.
In a 50 patient, Phase II, open label trial, treatment with selumetinib resulted in a 70% objective response in pediatric patients with neurofibromatosis type 1 and inoperable plexiform neurofibromas.
In a 30-patient, Phase II, open-label Chinese trial, treatment with rivoceranib plus vinorelbine resulted in an overall response rate of 36.7% in patients with wild-type advanced non-small-cell lung cancer.
Viltolarsen is available in an expanded access program for patients with Duchenne muscular dystrophy amenable to exon 53 skipping that meet criteria.
In a 48-month, 562 patient, Phase II trial, mean titres were 378 in two-dose, 421 in one-dose, 719 in one-dose plus 1-year booster compared to 100 with placebo in children ages two to 17 years living in dengue-endemic areas. Virologically confirmed dengue was recorded in 2% of TAK-003 and 7% of placebo patients. In the 18-month, 20,099 patient, Phase III, TIDES trial, 80.2% of patients that received TAK-003 developed a virologically confirmed dengue compared to placebo in children and adolescents ages four to 16 years living in dengue-endemic areas.
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