Dupixent seeks to expand its indication to COPD

after being approved for prurigo nodularis

Was additionally approved for prurigo nodularis in Korea

Confirmed improved lung function in Phase III trial on COPD

Indications for the interleukin inhibitor ‘Dupixent’ is being expanded actively in the field.

 

According to industry sources, after being approved for rashes, Sanofi’s Dupixent (dupilumab) has further demonstrated efficacy in chronic obstructive pulmonary disease (COPD) and is seeking to expand its indication to the area.

 

Its indication for itchy rashes has been approved recently in Korea.

 

Specifically, it has been approved for the treatment of adult patients aged 18 years or older with moderate-to-severe prurigo nodularis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

 

Prurigo nodularis is a chronic, debilitating inflammatory disease that is correlated with the skin, immune system, and nervous system in association with type 2 inflammation.

 

The intense itching arising from the condition can be worsen continuously due to neuro-immune interactions.

 

It can occur at any age but has a particularly high incidence in people in their 50s and 60s.

 

More than 80% of patients experience itching lasting more than 6 months and more than 50% experience itching lasting more than 2 years.

 

Over 60% experience sleep disturbances and affected patients were found to be more likely to suffer from depression and anxiety than healthy individuals.

 

Dupixent is a fully human monoclonal antibody that inhibits the signaling pathways of interleukin-4 (IL-4) and interleukin-13 (IL-13), which are the main causes of Type 2 inflammation.

 

IL-3 and IL-13 are known to be key and central drivers of the type 2 inflammation that plays a major role in multiple diseases including prurigo nodularis, atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), etc.

 

The indication expansion to prurigo nodularis was made based on the data from two placebo-controlled Phase III trials, PRIME and PRIME2.

 

Pruritus improvement in the two trials, as measured by the proportion of patients with a ≥4-point reduction in Worst Itch Numeric Rating Scale (WI-NRS), showed that 60% and 57.7% of patients in the Dupixent arm of the PRIME and PRIME2 study achieved significant WI-NRS reduction, compared with the 18.4% and 19.5% in the placebo arm, respectively.

 

In terms of treatment effect on skin lesions, 48% and 45% of patients in the Dupixent arm of the PRIME and PRIME2 trial continued to show improvement at Week 24, achieving more than double reduction of ‘clear’ or ‘almost clear’ skin.

 

Expectations for the drug’s potential in COPD had risen with the company’s announcement of positive results from its second Phase III trial, NOTUS.

 

The NOTUS is a placebo-controlled Phase III trial that evaluated the efficacy and safety of Dupixent in adults whose conditions are not controlled using triple therapy of inhaled corticosteroids (ICS), long-acting beta-agonists (LABA), and long-acting muscarinic antagonists (LAMA).

 

The study found that Dupixent rapidly and significantly improved lung function by week 12 and that these benefits were sustained through week 52.

 

Based on the positive results of the landmark BOREAS study the FDA granted Breakthrough Therapy designation for Dupixent as an add-on maintenance treatment in adult patients with uncontrolled COPD associated with a history of exacerbations and an eosinophilic phenotype