Global pharma powerhouse GSK has received FDA approval for its two-doses-a-year medicine for severe asthma.

 

The approval for Exdensur (depemokimab-ulaa) comes on the back of SWIFT-1 and SWIFT-2 Phase III trials, where depemokimab demonstrated a dramatic reduction in asthma exacerbations with just two doses per year. 

 

In SWIFT-1, patients saw a 58% drop in annualized asthma attacks while SWIFT-2 showed a 48% reduction, both compared with placebo. Statistically significant results were confirmed in both trials.

 

A pooled analysis revealed a 72% reduction in severe exacerbations requiring hospitalization or emergency care compared with placebo, highlighting Exdensur’s potential to reduce healthcare burden. Importantly, depemokimab was well-tolerated, with side effect rates similar to placebo.

 

Kaivan Khavandi, SVP & Global Head, Respiratory, Immunology & Inflammation R&D at GSK, said: "Physicians in the US now have the option to provide sustained protection from exacerbations for patients living with severe asthma with an eosinophilic phenotype in just two doses a year. Exdensur could redefine patient care and further establish the use of biologics for those who continue to experience exacerbations despite treatment.”

 

Depemokimab’s extended half-life allows it to target type 2 inflammation with twice-yearly dosing, potentially improving patient outcomes and easing the strain on healthcare systems.

 

Geoffrey Chupp, Professor at Yale University, added: "Current biologic treatments for asthma are often underutilised and frequent injections can be inconvenient for many patients and lead to inconsistent use. 

 

"There is clearly an opportunity to provide a longer duration of protection from exacerbations between injections for severe asthma patients that reduces the frequency of doses and may improve overall health care utilisation. Exdensur could empower physicians and patients to potentially achieve their treatment goals with fewer injections.”

 

Tonya Winders, President and CEO of Global Allergy & Airways Patient Platform, commented: "The struggle for people living with severe asthma is immense, with many silently enduring continued symptom recurrence and exacerbations. 

 

"An innovative treatment option like Exdensur that offers the long-acting protection from exacerbations that severe asthma patients with an eosinophilic phenotype deserve, with the benefit of fewer doses, is truly welcome.”