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Sanofi/Regeneron wins another EU approval for Dupixent

Becomes first biologic approved in EU for CRSwNP indication

Sanofi

Sanofi/Regeneron has added another indication to its anti-inflammatory medication Dupixent (dupilumab), this time in adults with severe chronic rhinosinusitis with nasal polyposis (CRSwNP). 

The European Commission has approved the new indication based on two phase 3 trials – SINUS-24 and SINUS-52 – which evaluated the Regeneron-partnered Dupixent plus standard-of-care intranasal corticosteroids compared to placebo plus intranasal corticosteroids.

The data from these trials demonstrated that Dupixent significantly improved key disease measures, meeting all primary and secondary endpoints. This included a 57% and 51% improvement in nasal congestion/obstruction severity, compared to 19% and 15% in the placebo groups in SINUS-24 and SINUS-52.

It also demonstrated a 33% and 27% reduction in participant’s nasal polyps score compared to a 7% and 4% increase with placebo in the respective studies.

Treatment with Dupixent also resulted in a significant reduction (74%) of systemic corticosteroid use and the need for sino-nasal surgery (83%) compared to the placebo group.

“Dupixent significantly improved the signs and symptoms of severe CRSwNP, and also eliminated the need for further surgery or corticosteroid use in approximately three-quarters of patients,” said George Yancopoulos, president and chief scientific officer at Regeneron.

“Today’s approval provides patients in Europe with the first biologic treatment to address the type 2 inflammation that underlies most CRSwNP. This is the third type 2 disease in which Dupixent has been approved, and we continue to investigate Dupixent in a broad range of type 2 inflammatory diseases,” he added.

Dupixent is a fully human monoclonal antibody that inhibits the signalling of the interleukin-4 and interleukin-13 proteins, which are believed to be key drivers of the type 2 inflammation that plays a significant role in CRSwNP, asthma and atopic dermatitis.

In addition to this new indication, Dupixent is also approved for use in patients 12 years and older as an add-on maintenance treatment for severe asthma with type 2 inflammation who have poor control.

It is also approved in patients 12 years and older with moderate-to-severe atopic dermatitis who are candidates for systemic therapy.

Aside from the EU, Dupixent has been approved for use in specific patients with moderate-to-severe atopic dermatitis and certain patients with asthma in a number of other countries including the US and Japan. Dupixent is already approved in the US for use with other medicines to treat CRSwNP in adults whose disease is poorly controlled.

Dupixent was the main driver of Sanofi’s growth in its second quarter revenues, which contributed €496m in the quarter – a rise of 181%. It is likely that this growth will continue in Q3, with Sanofi due to unveil the figures on 31 October 2019.

Article by
Lucy Parsons

30th October 2019

From: Regulatory

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