Sanofi, Regeneron build their case for yet another approval for immunology star Dupixent
Over the weekend Sanofi and Regeneron posted another upbeat round of data from their Phase III program for the powerhouse Dupixent — this time in eosinophilic esophagitis. And they made it clear that they’ll be using the results to hunt yet another regulatory nod for the mega blockbuster franchise this year.
Researchers for the partners turned out at the 2022 AAAAI annual meeting to tout a 64% reduction in disease symptoms from baseline compared to 41% for placebo. They added:
Nearly 10 times as many patients receiving Dupixent achieved histological disease remission: 59% of patients achieved histological disease remission compared to 6% of patients receiving placebo (p<0.0001); mean baseline peak levels were 89 and 84 eos/hpf, respectively.
“Currently, there are no FDA-approved treatment options that address the underlying drivers of this disease,” said Evan Dellon, the co-primary investigator on the study. “The data from this trial showed dupilumab taken weekly not only improved patients’ ability to swallow, but also reduced markers of type 2 inflammation in the esophagus, indicating its potential to address a major underlying cause of eosinophilic esophagitis.”
The success here comes just a couple of months after Takeda was handed a CRL for TAK-721, designed to treat the same ailment, which is a an allergic reaction in the esophagus. Once a top drug prospect, Takeda will need to run another study before the FDA takes a look at it again.
That will give Sanofi and Regeneron plenty of time to dominate that market niche, if Takeda chooses to try it again.