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Sanofi's Dupixent gains asthma approval in Europe

Drug on track to meet blockbuster forecasts

Sanofi

Sanofi and Regeneron’s Dupixent will now enter the asthma market in Europe, the new expansion confirming its blockbuster profile.

The dual IL-4 and IL-13 inhibitor has just gained approval for the new use in the European Union, and the partners are amassing data which shows it can alleviate symptoms for patients who suffer several inflammatory conditions at the same time.

Already approved in atopic dermatitis, the drug can now be used an add-on maintenance treatment for asthma patients with type 2 inflammation. This puts it into direct competition with some established players in that field, GSK's Nucala and AstraZeneca's Fasenra.

Type 2 inflammation is characterised by raised blood eosinophils, a type of armed white blood cell, and/or raised fractional exhaled nitric oxide (FeNO), which determines a quantitative measure of airway inflammation.

However, Dupixent can only be used in this setting when patients have used at least one other maintenance treatment, along with high dose inhaled corticosteroid (ICS)

"Type 2 inflammation is responsible for many of the hallmark symptoms of asthma – and Dupixent is the first and only treatment approved for patients in the European Union with severe asthma characterised by multiple biomarkers of type 2 inflammation," said George Yancopoulos, President and chief scientific officer at Regeneron.

"Dupixent is now approved in asthma and atopic dermatitis, and we continue to study this novel treatment in younger populations with these diseases, as well as other conditions driven by type 2 inflammation, including environmental allergies."

The approval was based on phase 3 QUEST and VENTURE trials, the former of which enrolled 1,902 patients with persistent asthma and evaluated the effect of adding Dupixent to standard-of-care therapy.

Results showed the drug reduced up to 67% exacerbations by week 52 compared to placebo and by week 12, the drug improved lung function by up to 33% by week 12 compared to 16% of those enrolled in the placebo arm.

It was also effective in those dependent on oral corticosteroids, which asthma guidelines suggest limiting their use to the most severe patients due to serious side effects.

John Reed, Head of Research and Development at Sanofi said the approval was an important milestone in asthma treatment in Europe.

"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 medications, including those dependent on oral corticosteroids – which may have potentially serious side effects when used chronically."

The companies have big plans for the drug, researching its clinical benefit in other diseases driven by allergic and other type 2 inflammation, including chronic rhinosinusitis with nasal polyps.

A phase 3 showed that Dupixent significantly improved nasal polyp scores compared to placebo and the FDA has recently granted a priority review of Dupixent in this setting.

The drug is also being investigated in COPD. However, speaking to analysts on their Q1 call, Regeneron's leadership duo Leonard Schleifer and George Yancopoulos tried to temper expectations about the drug's performance against this hard-to-treat condition.

"COPD is I think much tougher. It's worth looking at, but we wouldn't rank this as something with a high degree of confidence," commented Schleifer.

George Yancopoulos added: "Yes...COPD is a very complex disease. And the problem is that in the real world, the data suggests that it is indeed quite complicated in terms of it's impacted by asthma and type-2 diseases. And so, there are a lot of patients who have COPD whose diseases worsen with these related type-2 toxicity."

Yancopoulos said the key to the development in this field was finding the right patients to treat, and also negotiating with the FDA, which he says "likes to study cleaner diseases."

He concluded: "As Len said...it can be a complicated story and we'll see what the data says."

8th May 2019

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