Sanofi’s first-in-class biologic therapy for asthma on PBAC agenda

Pharma News: A first-in-class biologic therapy which targets two key proteins responsible for the overreaction of the immune system in severe uncontrolled asthma is set to be considered for PBS listing.

Sanofi Genzyme confirmed that the Pharmaceutical Benefits Advisory Committee (PBAC) would review a submission to reimburse Dupixent (dupilumab) subcutaneous injection for eligible severe asthma patients at the November 2020 meeting.

Dupixent is jointly developed by Sanofi and Regeneron under a global collaboration agreement.

Described as ‘a pipeline in a product’, Dupixent (dupilumab) is the first therapy to block interleukin-4 and interleukin-13, two cytokines that play a key and central role in type 2 inflammation that underlies specific types of asthma, as well as other forms of allergic and atopic disease. Around 50% of adults with severe asthma have type 2 inflammation.

Sanofi Genzyme Australia and New Zealand Head of Medical, Dr Paul King said that the submission was “an important milestone for Australians with uncontrolled severe asthma who despite receiving the standard of care, live with coughing, wheezing and difficulty breathing that often results in hospitalisation”.

“Dupixent is the first and only therapy approved for patients with type 2 inflammatory asthma which blocks the two proteins (IL-4 and IL-13) responsible for the excessive immune reaction and breaks the cycle of inflammation in the airways,” Dr King said.

In three pivotal clinical trials (QUEST5, DRI125446, and VENTURE7) involving 2,888 patients aged 12 years or more with moderate to severe asthma, Dupixent significantly:

1. Improved lung function as early as two weeks, regardless of the patient’s dependence on oral corticosteroids, with lung function improvements maintained throughout the duration of the 52-week study.
2. Reduced the rate of severe asthma exacerbations up to 70% (compared to placebo), with greater reductions in the rate of severe exacerbations in patients with higher baseline biomarker levels of type 2 inflammation, such as eosinophils and FeNO.
3. Reduced the dose of oral corticosteroids required by patients with steroid dependent asthma by 28.2% (compared to placebo) over 24-weeks in VENTURE trial. At the end of the study, more than half (52%) of patients treated with Dupixent no longer used oral corticosteroids (compared to 29% in the placebo group).

Dr King said that despite the range of steroidal and biologic treatments available for severe asthma, some patients remain poorly controlled. “Rather than trying to reduce inflammation and symptoms as they intensify, it’s important to target type 2 inflammation and neutralise the inflammatory response at its source.”

“In clinical trials, Dupixent not only reduced exacerbations and oral corticosteroid use, but it also improved lung function and patients’ overall quality of life. Dupixent offers a new treatment option for those who remain inadequately controlled with current standard of care medications,” he added.

Sanofi Genzyme Australia and New Zealand confirmed that the company is continuing to work with the Federal Government to have Dupixent included on the PBS for eligible severe atopic dermatitis patients.

“We also have our eye to the future with our robust clinical trial program that demonstrates our commitment to type 2 inflammatory diseases,” Dr King added.

In Australia, Dupixent is currently TGA registered and indicated for the treatment of moderate to severe atopic dermatitis in adult patients who are candidates for chronic systemic therapy.