The European Commission approved Dupixent (dupilumab) for use in adults and adolescents 12 years and older as an add-on maintenance treatment for severe asthma with type 2 inflammation characterized by raised blood eosinophils and/or raised fractional exhaled nitric oxide, who are inadequately controlled with high dose inhaled corticosteroid plus another medicinal product for maintenance treatment.
Nearly two weeks after the U.S. Food and Drug Administration approved Sanofi and Regeneron’s Dupixent as an add-on maintenance therapy for moderate to severe asthma, the France-based company reported a surge in sales for the medication in the third-quarter 2018 report.
AstraZeneca released positive results from the BORA Phase III extension clinical trial of Fasenra (benralizumab) as an add-on maintenance therapy in patients with severe eosinophilic asthma that had already completed either the SIROCCO or CALIMA Phase III trials.
GlaxoSmithKline said U.S. health authorities asked for more information about the company’s Nucala drug for use in combating chronic obstructive pulmonary disease (COPD).
Amgen and AstraZeneca announced that the U.S. FDA granted Breakthrough Therapy Designation for tezepelumab in patients with severe asthma without an eosinophilic phenotype.
GlaxoSmithKline’s Nucala won a key recommendation from a European Medicines Agency panel for use in the treatment of children with severe asthma.
A U.S. Food and Drug Administration expert panel did not support approval of GlaxoSmithKline Plc’s drug Nucala in treating a disease that limits airflow to the lungs.
U.S. Food and Drug Administration staff reviewers raised doubts over the effectiveness of GlaxoSmithKline Plc’s drug Nucala in treating a disease that limits airflow to the lungs.
GlaxoSmithKline continues to tout the benefits of the severe asthma treatment Nucala. The company unveiled long-term data showing that one-third of patients treated with Nucala (mepolizumab) experienced no asthma-related exacerbations during the study.
The U.S. FDA accepted for review the supplemental BLA of Dupixent (dupilumab) as an add-on maintenance treatment in certain adults and adolescents with moderate-to-severe asthma.