GSK wins US approval for twice-yearly asthma drug

FDA approves Exdensur for severe asthma

The U.S. Food and Drug Administration has approved Exdensur (depemokimab-ulaa) as an add-on maintenance treatment for severe asthma with an eosinophilic phenotype in adult and pediatric patients aged 12 years and older.

GSK Gets FDA Approval for New Severe Asthma Drug With a Dosing Advantage

GSK’s Exdensur requires just two injections a year to treat severe asthma. Less frequent injections give this new biologic medicine a dosing edge over one of GSK’s own blockbuster respiratory products as well as severe asthma drugs from companies such as AstraZeneca, Sanofi, and Amgen. The post GSK Gets FDA Approval for New Severe Asthma Drug With a Dosing Advantage appeared first on MedCity News.

GSK Says US FDA Approved Its Twice-Annual Asthma Drug Exdensur

GSK Plc said it won US approval for a drug to treat severe asthma, boosting its prospects as a potential blockbuster.

First Twice-Yearly Biologic Approved for Severe Eosinophilic Asthma

(MedPage Today) -- The FDA approved depemokimab (Exdensur) as the first ultra-long-acting biologic with twice-yearly dosing approved for patients with severe asthma with an eosinophilic phenotype, GSK announced. The subcutaneous anti-interleukin...

FDA clears GSK’s twice-yearly asthma drug

Exdensur is now the first asthma biologic to be approved for twice-yearly dosing, and could potentially change standard of care for those with severe disease.

UK, US approve GSK's twice-yearly asthma drug

GSK scores a first approval in the UK for new severe asthma and CRSwNP therapy Exdensur, but a second in the US covers the asthma indication only.