GSK: seeks additional indication for anti-inflammatory drug
(CercleFinance.com) - On Monday GlaxoSmithKline said that it has submitted an application to the US Food and Drug Administration, seeking an additional indication for its Nucala drug.
GSK has filed a supplemental biologics license application to the FDA for the use of Nucala as an add-on treatment for severe eosinophilic asthma in patients aged six to 11 years.
There are currently no targeted biologic therapies available in the US for patients who are as young as six years old, the drugmaker said.
Nucala, a monoclonal antibody, was approved in the US in 2015 for use as an add-on treatment for patients, aged 12 years or older, with severe asthma and an eosinophilic phenotype.
Last Friday, GSK's ViiV Healthcare said it received a positive opinion from EU health regulators for its two-drug HIV treatment Tivicay plus lamivudine.
GSK shares are currently up 0.8% in London.
Copyright (c) 2018 CercleFinance.com. All rights reserved.
GSK has filed a supplemental biologics license application to the FDA for the use of Nucala as an add-on treatment for severe eosinophilic asthma in patients aged six to 11 years.
There are currently no targeted biologic therapies available in the US for patients who are as young as six years old, the drugmaker said.
Nucala, a monoclonal antibody, was approved in the US in 2015 for use as an add-on treatment for patients, aged 12 years or older, with severe asthma and an eosinophilic phenotype.
Last Friday, GSK's ViiV Healthcare said it received a positive opinion from EU health regulators for its two-drug HIV treatment Tivicay plus lamivudine.
GSK shares are currently up 0.8% in London.
Copyright (c) 2018 CercleFinance.com. All rights reserved.