Nucor earnings beat by $0.08, revenue fell short of estimates
Investing.com -- The US Food and Drug Administration has accepted GlaxoSmithKline (NYSE:GSK)’s biologics license application for depemokimab, a monoclonal antibody targeting interleukin-5 (IL-5), for regulatory review in two indications, GSK (LON:GSK) said in a statement on Monday.
The proposed uses include an add-on maintenance treatment for asthma in patients aged 12 and older with type 2 inflammation and an eosinophilic phenotype, and as an add-on therapy for adults with chronic rhinosinusitis with nasal polyps (CRSwNP) who have not responded adequately to current treatments.
The FDA has set a prescription drug user fee act target date of December 16, for its decision. Depemokimab is an ultra-long-acting biologic designed to suppress IL-5, a key driver of type 2 inflammation.
The drug has been tested in clinical trials that support a dosing regimen of just two injections per year. Results from the SWIFT and ANCHOR phase III trials demonstrated that depemokimab effectively inhibited IL-5, leading to improvements in clinical outcomes.
The drug’s extended half-life and high potency suggest that longer intervals between doses could improve patient adherence, a challenge seen with many chronic disease treatments.
Type 2 inflammation, identified by elevated eosinophil levels, is a major contributor to asthma and CRSwNP. It is present in most patients with severe asthma, contributing to exacerbations and hospitalizations.
In CRSwNP, type 2 inflammation is associated with more severe symptoms, including nasal obstruction, loss of smell, and sleep disturbances.
Studies indicate that up to 85% of patients with CRSwNP experience type 2 inflammation, making IL-5 suppression a promising therapeutic strategy.
Asthma remains a significant health burden in the United States, affecting over 26 million people.
A substantial portion of these patients experience severe asthma attacks each year, leading to emergency department visits and hospitalizations.
Similarly, CRSwNP impacts around 2.1% of the U.S. population, with up to 30% of affected individuals developing nasal polyps that worsen their symptoms and quality of life.
The inflammatory nature of these conditions often results in long-term health complications and increased healthcare utilization.
The phase III trials evaluating depemokimab included SWIFT-1 and SWIFT-2 for asthma and ANCHOR-1 and ANCHOR-2 for CRSwNP. Both asthma studies were 52-week, placebo-controlled trials assessing the efficacy and safety of depemokimab in patients receiving medium- to high-dose inhaled corticosteroids plus an additional controller.
The CRSwNP trials followed a similar structure, with patients randomized to receive either depemokimab or placebo.
The trials met their primary endpoints, showing reductions in nasal polyp size and nasal obstruction severity in CRSwNP patients and improvements in asthma control in those with type 2 inflammation.
Depemokimab is also under investigation for other IL-5-mediated conditions, including eosinophilic granulomatosis with polyangiitis and hypereosinophilic syndrome.
Ongoing research aims to further understand the role of IL-5 in various immune and respiratory diseases and how targeting it could alter disease progression.