Regeneron and Sanofi’s new injected immunology drug Dupixent has taken off like a rocket, leading to some lofty projections for its peak upside. Like $10 billion-plus. But with some easier-to-take oral competitors percolating in pipelines, some analysts believe it is time to take at least a little of the air out of those forecasts.
A flurry of analyst notes went out Thursday after AbbVie released phase 2b data showing its JAK-1 selective inhibitor upadacitinib hit its primary endpoints in atopic dermatitis, commonly known as eczema. One analyst also noted a potential threat from a first-in-class thymic stromal lymphopoietin antagonist, tezepelumab, from AstraZeneca and Amgen for treating severe asthma.
Bernstein analyst Ronny Gal told clients that the drug candidate from AbbVie, as well as the one from Amgen and AstraZeneca, could pose a threat to Dupixent and those $10 billion estimates.
“The results today take nothing from the profile of Dupixent, which may still lead the market in both indications. However, it does suggest competition will be coming for the drug and competition being what it is, some of the higher end estimates for the drug may need to come down,” he told clients in a note.
The two new drugs still have some distance to close to get to the market, while Dupixent is eating up market share. But one of the advantages of the AbbVie candidate, and other JAK inhibitors also under development, is that they can be taken by mouth instead of the injection required of Dupixent, Leerink analyst Geoffrey Porges pointed out in a note to clients.
Regeneron and Sanofi face the permanent liability of their fixed every-two-week injectable dosing schedule for Dupixent, “which is likely to be a liability compared to the orally administered JAK inhibitors, and also to other injectables, which appear to be aiming for monthly or even less frequent dosing,” Porges wrote.
Approved in late March, Dupixent was tagged by Sanofi and Regeneron with a $37,000 list price. Its rollout, despite some pushback from payers, has put it on a blockbuster path. By late July, the drug's script numbers were between 1,500 and 1,600, up from around 1,000 six weeks earlier.
That was all for treating adults with moderate-to-severe atopic dermatitis, for which it was initially approved. But the partners have big expectations for the drug in other categories and are gearing up for a fourth-quarter Dupixent filing in asthma, with late-stage data due for release soon.
Of course, that is also the indication being looked at by Amgen and AstraZeneca for their drug candidate. And Leerink analyst Seamus Fernandez suggests their candidate could get a faster-than-expected approval if the partners are able to persuade the FDA to approve it on the strength of the phase 2b data while they carry out a confirmatory phase 3 trial. The FDA has done that before. It did it with Dupixent.