Regeneron speeds toward the FDA with its would-be asthma blockbuster

Regeneron ($REGN) has advanced dupilumab, regarded by many as the company's next big innovation, into a Phase III asthma study, rolling toward an FDA submission behind its lead eczema program.

The injection, partnered with Sanofi ($SNY), targets two proteins, interleukin-4 and interleukin-13, that play a key role in the inflammatory process, and Regeneron believes it could treat a wide range of allergic ailments with a common root. The antibody is already in Phase III for its primary indication of eczema, and now the Big Biotech has launched a 1,600-patient pivotal trial in asthma, testing two doses of dupilumab to see how well the treatment can improve lung function.

Meanwhile, after meeting with the FDA, Regeneron now believes the agency will recognize an earlier Phase IIb asthma study as one of two required pivotal trials. In that trial, the highest doses of dupilumab significantly beat out placebo in improving lung function among asthmatics and reduced the rate of flare-ups, notching particularly positive effects on patients with low white blood cell counts.

The plan now is to complete the recently initiated Phase III study and, if everything works out, submit the results of both trials in hopes of picking up FDA approval in asthma thereafter.

Regeneron CSO George Yancopoulos

The company has been careful not to spell out specific timelines for dupilumab, working through a slate of Phase III eczema trials after securing the FDA's coveted breakthrough-therapy designation in November. Analysts have said the drug could bring in peak sales of more than $2.5 billion a year with approvals in eczema and asthma, and Regeneron is running Phase II studies in ​chronic sinusitis and eosinophilic esophagitis in hopes of establishing dupilumab as a go-to treatment for a wide range of allergic ailments.

That potential establishes why dupilumab "could be the next Praluent," as Chief Scientific Officer George Yancopoulos said on a February earnings call, name-checking the cholesterol-busting antibody expected to bring in billions for Regeneron and Sanofi if and when it wins FDA approval this summer.

- read the statement

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