Eosinophilic Asthma – PharmaLive

A look at upcoming PDUFA dates for the U.S. Food and Drug Administration, including Viela Bio’s inebilizumab for NMOSD.

June 8, 2020/by BioSpace

FDA Approves GSK’s Nucala for Children with Severe Eosinophilic Asthma

Approvals, Biologics, Children, Chronic Obstructive Pulmonary Disease (COPD), Clinical Data, FDA, FDA/Regulatory, Severe Eosinophilic Asthma

The FDA greenlit GlaxoSmithKline’s Nucala (mepolizumab) for treating severe eosinophilic asthma in children as young as 6 years.

September 13, 2019/by BioSpace

Sanofi’s eczema product Dupixent wins FDA approval to treat asthma

Approvals, Asthma, Atopic Dermatitis (Eczema), Eosinophilic Asthma, FDA, FDA/Regulatory, Nasal Polyps, New Indications, Pediatric Asthma, Steroids

Sanofi SA’s eczema drug Dupixent was approved by the U.S. Food and Drug Administration as an additional maintenance therapy in patients with two types of asthma.

October 19, 2018/by Reuters Health

AstraZeneca’s Asthma Drug Looks Good in Multiple Late-Stage Trials

Chemotherapy, Clinical Trials, Corticosteroids, Eosinophilic Asthma, FDA, Hairy Cell Leukemia, Lung Functions, National Cancer Institute, Priority Review Status, R&D, Severe Asthma

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.

September 19, 2018/by BioSpace

Tezepelumab Granted Breakthrough Therapy By FDA

Biomarkers, Breakthrough Therapy Designation, Clinical Trials, Collaboration, Eosinophilic Phenotype, FDA/Regulatory, First-In-Class, Inflammation, R&D, Severe Asthma

Amgen and AstraZeneca announced that the U.S. FDA granted Breakthrough Therapy Designation for tezepelumab in patients with severe asthma without an eosinophilic phenotype.

September 7, 2018/by PR Newswire

AstraZeneca drug Fasenra fails to achieve main goal in COPD trial

Biologicals, Clinical Trials, COPD, Eosinophilic Asthma, R&D, Respiratory Disease

AstraZeneca’s first respiratory biological medicine Fasenra failed to meet its main target in a second clinical trial treating patients with moderate to very severe chronic obstructive pulmonary disease (COPD).

May 30, 2018/by Reuters Health