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FDA clears Dupixent as first-ever drug for chronic rhinosinusitis with nasal polyps

Could add $1bn to revenues, say analysts


Sanofi and Regeneron have another approved use for their fast-growing immunology drug Dupixent after the FDA gave the nod to its use in adults with chronic rhinosinusitis with nasal polyposis (CRSwNP).

Dupixent (dupilumab) is the first treatment to be approved as an option for patients who can’t manage their symptoms using intranasal steroids, the standard first-line of treatment for troublesome nasal polyps, according to an FDA press release.

“Nasal polyps can lead to loss of smell and often patients require surgery to remove the polyps,” said the agency’s head of pulmonary, allergy and rheumatology products Sally Seymour.

As well as providing another option for patients, Dupixent “also reduces the need for nasal polyp surgery and oral steroids”, she added.

Dupixent – an IL-4 and IL-13 inhibitor that is one of the fast-growing drugs in both Sanofi and Regeneron’s portfolios – is already approved in the US for atopic dermatitis and as add-on maintenance therapy for asthma with an eosinophilic phenotype or in patients dependent on oral corticosteroids.

Trials of the drug in nasal polyps have showed that it could significantly reduce polyp size and nasal congestion, while patients taking Dupixent also reported an increased ability to smell and required less nasal polyp surgery and oral steroids. Analysts have suggested that the new indication is worth up to $1bn in additional sales.

After a slow start, the drug has steadily been gathering sales momentum and is already knocking on the door of $1bn-plus sales, with some analysts predicting it could reach $7.5bn product at peak.

Sanofi and Regeneron seem to have a fair lead over other drug candidates in the nasal polyp indication.

Roche and Novartis’ severe asthma therapy Xolair (omalizumab) has data showing it is effective as a treatment for polyps, but isn’t expected to be approved until the end of next year at the earliest, giving Sanofi and Regeneron plenty of time to establish Dupixent as the go-to treatment.

Chronic rhinosinusitis with nasal polyposis is the latest indication to be added to the label, but the two partners have also set their sights on eosinophilic esophagitis, various food and environmental allergies and chronic obstructive pulmonary disease (COPD), a much larger opportunity but also a tougher disease in which to show efficacy.

Article by
Phil Taylor

27th June 2019

From: Regulatory



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