Sanofi/Regeneron new asthma data bolstered by potential indications

Sanofi and Regeneron’s Dupixent is predicted to grow to be one of the largest selling drugs in the industry but the expectation has heaped pressure onto every release of data the companies release. Recent Phase 3 data in uncontrolled asthma was positive, boasting superior data to competitors, but did not indicate it could enter the market with a clear lead over rivals.

Sanofi’s CEO, Olivier Brandicourt, has moved to reassure investors by suggesting that the company is looking into expanding indications into nasal polyps, a comorbidity of asthma. As reported by Reuters, he made reference to Phase3 trial into this indication suggesting that it, in all likelihood, it would be the next indication to pursue after uncontrolled asthma.

The Phase 3 data in asthma showed that Dupixent comfortably met its primary endpoints, by lowering asthma exacerbations by 46% across all patients and between 60% to 67% in high-risk patients. Based on this data, the companies are expected to apply to the FDA by the end of the year and expect a quick turnaround on the eventual decision.

The treatment has emerging competitors in the field, however, with AstraZeneca and Amgen reporting strong data from Phase 2 trials for its tezepelumab treatment. There is also current market leader, GSK’s Nucala, that is already hoovering up a share of the 15% of patients who do not respond positively to the latest inhalers.

"We believe that therapies like dupilumab, which focus on specific molecular pathways such as the Th2 pathway associated with multiple chronic allergic diseases, are important targets for further investigation," said Elias Zerhouni, President, Global R&D, Sanofi. "The positive data from this large second pivotal trial in uncontrolled persistent asthma, following the positive results of dupilumab in atopic dermatitis, further support this view in our opinion. We will work diligently with health authorities to bring this new application of dupilumab to the patients who most need it."

Dupixent is already approved for the treatment of moderate-to-severe eczema, and it is widely expected to receive approval in uncontrolled asthma to add to this. Beyond this, Brandicourt comments suggest that its looking likely that nasal polyps will be the next target for the treatment.

The drug is estimated to hit sales of approximately $4.7 billion in annual sales by 2021 and could potentially rise to $12 billion by 2026.