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Kalydeco (ivacaftor) / VertexFDA Approves KALYDECO (ivacaftor) as First and Only CFTR Modulator to Treat Eligible Infants With CF as Early as Four Months of Age (Businesswire) - Sep 25, 2020 - "Vertex...today announced the U.S. Food and Drug Administration (FDA) approved KALYDECO® (ivacaftor) for use in children with cystic fibrosis (CF) ages four months to less than six months old who have at least one mutation in their cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to KALYDECO based on clinical and/or in vitro assay data....This FDA approval is based on data from a cohort in the 24-week Phase 3 open-label safety cohort (ARRIVAL)..."Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZenecaENHERTU Approved in Japan for the Treatment of Patients with HER2 Positive Metastatic Gastric Cancer (Daiichi Sankyo Press Release) - Sep 25, 2020 - "Daiichi Sankyo...today announced the approval of ENHERTU® (trastuzumab deruxtecan), a HER2 directed antibody drug conjugate (ADC), in Japan for the treatment of patients with HER2 positive unresectable advanced or recurrent gastric cancer that has progressed after chemotherapy....Approval of ENHERTU in Japan is based on the results of the open-label, randomized phase 2 DESTINYGastric01 trial..." Jyseleca (filgotinib) / GileadEuropean Commission Grants Marketing Authorization for Jyseleca (Filgotinib) for the Treatment of Adults With Moderate to Severe Active Rheumatoid Arthritis (Businesswire) - Sep 25, 2020 - "Gilead Sciences, Inc....and Galapagos NV...today announced that the European Commission (EC) has granted marketing authorization for Jyseleca® (filgotinib 200 mg and 100 mg tablets), a once-daily, oral, JAK1 inhibitor for the treatment of adults with moderate to severe active rheumatoid arthritis (RA) who have responded inadequately to, or are intolerant to, one or more disease modifying anti-rheumatic drugs (DMARDs). Jyseleca may be used as monotherapy or in combination with methotrexate (MTX)....The EC’s decision is supported by data from over 3,500 patients treated with Jyseleca across the Phase 3 FINCH and Phase 2 DARWIN programs....'We look forward to bringing this important treatment to physicians and patients across Europe as quickly as possible.'"Ayvakit (avapritinib) / Blueprint MedicinesBlueprint Medicines Announces European Commission Approval of AYVAKYT (avapritinib) for the Treatment of Adults with Unresectable or Metastatic PDGFRA D842V Mutant Gastrointestinal Stromal Tumors (Blueprint Medicines Press Release) - Sep 25, 2020 - "Blueprint Medicines Corporation...announced that the European Commission (EC) has granted conditional marketing authorization to AYVAKYT® (avapritinib) as a monotherapy for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST) harboring the platelet-derived growth factor receptor alpha (PDGFRA) D842V mutation. For the first time in Europe, there is an approved therapy for patients with PDGFRA D842V mutant GIST specifically designed to target the underlying molecular driver of their disease. The EC approval is based on efficacy results from the Phase 1 NAVIGATOR trial as well as combined safety results from the NAVIGATOR and Phase 3 VOYAGER trials."Abilify Maintena (aripiprazole depot formulation) / Otsuka, LundbeckOtsuka's ABILIFY MAINTENA approved for the additional indication of bipolar I disorder in Japan (Otsuka Press Release) - Sep 25, 2020 - "Otsuka Pharmaceutical Co., Ltd. announces that it has received regulatory approval in Japan for the additional indication of suppression of recurrence and relapse of mood episodes in bipolar I disorder for ABILIFY MAINTENA (aripiprazole), a long-acting injectable suspension. The approved indication covers the 300 mg and 400 mg vials (for injection) and the 300 mg and 400 mg dual-chamber syringes..."
