The FDA approved inebilizumab-cdon (Uplizna, Viela Bio) on 6/11/2020 for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.
The FDA designated Insmed’s brensocatib a Breakthrough Therapy for the treatment of non-cystic fibrosis bronchiectasis.
Leo Pharma announced the EU accepted the MAA for AstraZeneca/Leo Pharma’s tralokinumab as a treatment for moderate-to-severe atopic dermatitis.
Announced Research Updates
AbbVie announced that in the 12-week, 612 patient, Phase III, SELECT-CHOICE trial, patients treated with upadacitinib had a 2.52 reduction in their DAS28CRP score compared to a 2 point reduction with abatacept in patients with rheumatoid arthritis previously treated with a biologic.
GSK announced interim data from 18 patients enrolled in the Phase I/II, open-label, DREAMM-6 trial, where treatment with belantamab mafodotin plus bortezomib and dexamethasone resulted in an overall response rate of 78% in patients with relapsed/refractory multiple myeloma.
Pfizer announced that in a 12-week, 387 patient, Phase III, JADE MONO-TEEN trial, more patients treated with abrocitinib 200 mg achieved an IGA score of clear or almost clear skin and had a 2 point or > improvement in their IGA score compared to placebo in patients 12 to < 18 years of age with moderate to severe atopic dermatitis (AD) who were also on background topical therapy. Treatment with the 200 mg dose also resulted in more patients achieving at least a 75% or greater improvement in their Eczema Area and Severity Index (EASI) score compared to placebo. The 100 mg dose did not differ from placebo for IGA or EASI scores.
Opthea announced that in a 12-week, 155 patient Phase IIa trial, treatment with OPT-302 plus aflibercept did not improve the number of patients that achieved a 5 letter or > gain in Best Corrected Visual Acuity compared to aflibercept monotherapy (52% vs 60%) in patients with persistent diabetic macula edema despite regular intravitreal administration of prior anti-VEGF-A monotherapy.
Bluebird announced 6-month interim results for 16 patients enrolled in the Phase I/II, HGB-206 trial, where treatment with beta beglogene darolentivec resulted in total hemoglobin from 9.6 to 16.2 g/dL, HbAT87Q levels from 2.7 to 9.4 g/dL and a 99.5% mean reduction in annualized rate of vaso-occlusive crises and acute chest syndrome in patients with sickle cell disease.
ADC announced that in the 145 patient, Phase II, open-label, LOTIS 2 trial, treatment with loncastuximab tesirine resulted in an ORR of 48.3% and a complete response rate (CRR) of 24.1% in patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL). ADC announced interim results from 18 patients enrolled in the Phase I/II, open-label, LOTIS 3 trial, where treatment with loncastuximab tesirine plus ibrutinib resulted in an ORR of 66.7% and a CRR of 33% in patients with relapsed or refractory DLBCL or mantle cell lymphoma (MCL).
Published Research Updates
In the 12-month, 81 patient, Phase II, open-label, L-MIND trial, treatment with tafasitamab plus lenalidomide resulted in an overall response rate of 60% in patients with diffuse large B cell lymphoma. In a 92 patient, Phase II, open-label trial, treatment with tafasitamab resulted in an overall response rate of 26% in diffuse large B cell lymphoma patients, 29% in follicular lymphoma patients and 27% in indolent non-Hodgkin's lymphoma patients.
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