Sanofi/Regeneron muscle ahead of a rival Novartis/Roche team, win first approval in key rhinosinusitis field
Regeneron and their partners at Sanofi have beat the Novartis/Roche team to the punch on another key indication for their blockbuster anti-inflammatory drug Dupixent. The drug team scored an accelerated FDA approval for chronic rhinosinusitis with nasal polyps, making this the first such NDA for the field.
Analysts have been watching this race for a while now, as Sanofi/Regeneron won a snap priority review for what is now their third disease indication for this treatment. And they’re not nearly done, building up hopes for a major franchise.
“In fact, approximately three-quarters of patients treated with Dupixent no longer required either corticosteroids or surgery, the current standards of care,” said Regeneron science chief George Yancopoulos. “Importantly, many patients with CRSwNP also suffer from asthma, and Dupixent was shown to improve lung function in these patients as well. This approval further reinforces that IL-4 and IL-13 are key drivers of type 2 inflammation, and we continue to study Dupixent in other type 2 inflammatory diseases, including eosinophilic esophagitis, and food and environmental allergies.”
Just a few weeks ago Novartis touted a Phase III success for their bestseller Xolair in the same arena. But while they noted a win on co-primary and secondary endpoints, the data were held back. And while they now have an odds-on shot at a new approval for the drug, there’s no sign how it will compare with Dupixent.
Evan Seigerman at Credit Suisse sized up today’s news and noted:
We project peak revenues of ~$450M with $250M by 2024. We estimate the world-wide CRSwNP patients on Dupixent at ~9k by 2024, which is about 8-10X smaller than asthma or AD populations. In our view, the expanded indication represents a smaller opportunity compared to asthma and AD. However, CRSwNP does add incremental sales for Dupixent, and provides a synergistic benefit with asthma and AD (>60% comorbidity overlap). Our discussions with physicians indicate that Dupixent’s broad label is an important driver in brand preference over other biologics (AZ’s Fasenra or GSK’s Nucala).
The two pharma giants are defending Xolair — which blocks immunoglobulin E — against a growing group of rivals in asthma, where Dupixent is also approved. But they’ll be playing come-from-behind in chronic rhinosinusitis, never an enviable position in pharma.