Paris, France — Recognizing that the impact of multiple sclerosis (MS) goes beyond the conventionally recognized symptoms, Sanofi has announced a new app to support people with the disease—specifically, their mental health. Created in partnership with Happify Health, the app joins the burgeoning collection of digital therapeutics (DTx), medications with very different looks and mechanisms of action than traditional drugs. DTx are software programs and, like a pill or injection, they must go through clinical trials and FDA approval. Currently, the app is in the middle of an online trial with several thousand MS patients participating; Sanofi expects to submit the app to the FDA later this year.
Sanofi, which owns Genzyme, manufacturer of the MS drugs Aubagio and Lemtrada, knows that people with MS are two to five times more likely than the general public to suffer from major depression. So, easing their mental health burden is a worthy goal in itself, but doing so may yield another, surprising upshot. As Ameet Nathwani, Sanofi’s chief medical officer, says, “If you can improve depression and anxiety in a clinically meaningful way in a very robust program, can you in patients with MS also improve some of their underlying MS symptomology? We know there are many relationships.” Nathwani went on to note that as Sanofi moves forward with testing the app and getting it approved, they will also assess “whether there are specific improvement in MS symptoms before making value propositions.”
For Sanofi, the move into DTx is a first. But Nathwani makes it clear that the company is “talking to other companies about digital therapy approaches in other diseases.” One day down the line, he says, “this could become more of a portfolio play where we would have a portfolio of digital therapeutics which are clinically meaningful and could be used as prescribed agents.”
The fairly recent advent of DTx raised many questions, for instance: how could you possibly create a trial for a software program? But leaders have created their own solutions in order to get these novel therapies to people in need. DTx—and their growing prominence—is a hot topic, seemingly signaling that the health care space is starting to support its customers in many of the same ways that other companies do across the broader commercial world. But Sanofi’s app reflects more than just the rise of DTx. It exemplifies the renewed focus health care innovators are making on reducing the stigma around mental health and supporting patients through every aspect of their journeys.