Sanofi’s Dupixent backed for nasal polyps use in Europe

Sanofi and Regeneron's fast-growing immunology drug Dupixent is on course for a third indication in Europe after being recommended for approval as a treatment for people with nasal polyps.

Dupixent (dupilumab) – an inhibitor of interleukins 4 and 13 – has been given a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) as an add-on therapy for chronic rhinosinusitis with nasal polyps (CRSwNP).

Sanofi and Regeneron's drug is already approved to treat atopic dermatitis and severe asthma in adults, and the green light in CRSwNP comes just three months after that indication was approved in the US.

The CHMP opinion covers use of Dupixent with intranasal corticosteroids – the standard first-line treatment - in adults with the condition.

In CRSwNP polyps obstruct the sinuses and nasal passages and can lead to persistent breathing difficulties, nasal congestion and discharge, reduced or loss of sense of smell and taste, and facial pressure or pain.

Trial results in nasal polyps reported late last year showed that the drug met all of its primary and secondary endpoints, significantly reducing nasal polyp size, nasal congestion severity, and the need for systemic corticosteroids and/or surgery.

Rapid take-up of Dupixent in atopic dermatitis and asthma caused sales of the antibody to almost triple to €825 million in the first half of the year, even before the approval in CRSwNP had time to have an impact, and the drug is expected to make more than $2 billion in the full-year.

Analysts have suggested that Dupixent could make several billion dollars in sales at its peak, with the CRSwNP indication worth up to $1 billion in in its own right. That will depend on how well it is received by payers of course, as its $36,000 list price is a huge premium on current generic therapies.

Sanofi and Regeneron also seem to have quite a lead in the market, as Dupixent's closest  rival – Roche and Novartis' Xolair (omalizumab) – is still in clinical testing for this indication.

The two partners are also developing Dupixent for a series of other follow-up indications that involve type 2 inflammation that occurs in allergic-type diseases. Trials are ongoing in paediatric atopic dermatitis and asthma, eosinophilic oesophagitis, chronic obstructive pulmonary disease (COPD), and food and environmental allergies.

Dupixent is a critically important drug for Sanofi, which is trying to rebuild sales momentum after losing market exclusivity for blockbuster insulin product Lantus for diabetes.