FiercePharma

GlaxoSmithKline's Nucala targets rival AstraZeneca with FDA nod for rare white blood cell disease

GlaxoSmithKline's immunology leader Nucala has been locked in a yearslong struggle with AstraZeneca's Fasenra for dominance in rare eosinophilic asthma. With a new rare disease approval, Nucala just ...
FiercePharma

GSK's Nucala shows up AZ's Fasenra with data win in rare inflammatory disease

GlaxoSmithKline’s Nucala needs a win in its fight against AstraZeneca’s Fasenra. Now, it can at least tout a first-data advantage in a rare inflammatory disease. In a phase 3 study, the rate of ...
Pharmaceutical Technology on MSN

GSK forges pact with Empirico for respiratory siRNA in $745m deal

GSK now has the global development and commercialisation rights to the COPD-targeting oligonucleotide, EMP-012.
Monthly Prescribing Reference

Nucala Approved for Self-Administration Via Autoinjector, Prefilled Safety Syringe

Previously, the treatment had only been available as a lyophilized powder for reconstitution that required administration by a healthcare professional. The Food and Drug Administration has approved ...
Nasdaq

FDA Approves Nucala as the First and Only Biologic Treatment for Hypereosinophilic Syndrome (HES)

Third US indication for Nucala demonstrates GSK’s commitment to finding new ways to help patients with eosinophil-driven diseases Dr Hal Barron, Chief Scientific Officer and President R&D, GSK, said: ...
Drug Store News

FDA approves new indication of GSK’s Nucala

The Food and Drug Administration has approved a 40 mg prefilled syringe of GSK’s Nucala (mepolizumab) for appropriate children aged 6 to 11 years old who have severe eosinophilic asthma. Nucala can ...
Yahoo

GSK's asthma drug Nucala meets main goal in study on treating smoker's lungs

(Reuters) -British drugmaker GSK said on Friday that its asthma drug, Nucala, met the main goal of a late-stage study in treating patients with chronic obstructive pulmonary disease (COPD), or ...
Monthly Prescribing Reference

Nucala Approved for Chronic Rhinosinusitis With Nasal Polyps

The approval was based on data from the phase 3 SYNAPSE study that evaluated mepolizumab as an add-on maintenance treatment in over 400 adults with CRSwNP. The Food and Drug Administration (FDA) has ...
Business Wire

Nucala is the first biologic approved in the US for six to 11-year-old children with severe eosinophilic asthma

Nucala (100mg dose subcutaneous injection) was first approved in 2015 as an add-on maintenance treatment for patients with severe eosinophilic asthma aged 12 years and older. This approval (40mg dose ...
Nasdaq

FDA Approves GlaxoSmithKline's Nucala To Treat Rare Blood Disorders

(RTTNews) - The U.S. Food and Drug Administration approved the first drug to treat adults and children aged 12 years and older with hypereosinophilic syndrome (HES) for six months or longer without ...
Business Insider

GSK's MUSCA study shows Nucala® (mepolizumab) significantly improves quality of life and lung function in severe asthma patients with an eosinophilic phenotype

LONDON, March 6, 2017 /PRNewswire/ -- GlaxoSmithKline plc (LSE/NYSE:GSK) today announced data demonstrating that severe asthma patients, whose disease is driven by eosinophilic inflammation, treated ...
Business Wire

FDA Approves Nucala as the First and Only Biologic Treatment for Hypereosinophilic Syndrome (HES)

LONDON--(BUSINESS WIRE)--GlaxoSmithKline plc (GSK) (LSE/NYSE: GSK) today announced the US Food and Drug Administration (FDA) has approved Nucala (mepolizumab) for the treatment of adult and pediatric ...