Sanofi and Regeneron have been granted EMA approval for Dupixent in atopic dermatitis, taking the product another step towards what some analysts predict will be blockbuster sales.
The EU approval is for the treatment of moderate-to severe atopic dermatitis (also known as eczema), a chronic skin condition characterised by skin blistering, cracking and often debilitating itching, and comes after the CHMP recommended the drug for approval in July.
Dupixent (dupilumab) is an interleukin-4 (IL-4) and IL-13 inhibitor that can be administered by a patient every other week via a subcutaneous injection after an initial loading dose, and in trials it has been shown to be effective at both clearing skin and helping patients avoid steroids and topical immunosuppressants such as cyclosporine and methotrexate, which can cause side effects with chronic use.
Earlier this month Sanofi and Regeneron reported new data at the European Academy of Dermatology and Venereology (EADV) conference that around 60% of patients with patients whose symptoms were uncontrolled despite cyclosporine therapy were able to achieve a 75% improvement in symptoms when Dupixent was added to topical steroids, compared to 30% of a placebo group.
Sanofi said in its second-quarter results statement that Dupixent had got off to a good start in its first market, the US, making €26m in its first quarter on the market, but that is only a fraction of what analysts think the product is capable of achieving.
Analysts have previously suggested Dupixent could eventually become a €5bn product at peak, particularly if it can also find a role in additional indications, and there was some encouraging news for Sanofi and Regeneron on that front a couple of weeks ago.
A phase III trial of the antibody in persistent, uncontrolled asthma met its targets of reducing the frequency of severe asthma attacks in patients with high levels of eosinophilic cells, setting up a filing before the end of the year. Some analysts said the data fell short of expectations however – particularly in light of increased competition in the severe asthma category from IL-5 inhibitors such as GlaxoSmithKline’s Nucala (mepolizumab) – and shares in the companies dipped as a result.
Dupixent is also being tested for its potential in nasal polyposis, another indication where it could see competition from Nucala.