Sanofi joins the digital therapeutics market Tuesday with a proposed app to improve mental health in patients with multiple sclerosis. Created in partnership with established mental health digital therapeutics firm Happify Health, the app is currently in a proof-of-concept online trial with several thousand MS patients.
After those results, expected later this year, are in, Sanofi and Happify plan to submit the app to the FDA to go through the regulatory process for software as a medical device.
The app is Sanofi’s first proposed digital therapeutic, and the company specifically chose MS as an entry point into the space because of its extensive experience with the condition, Ameet Nathwani, M.D., Sanofi’s chief medical officer and chief digital officer, said.
Statistics show that people living with MS are two to five times more likely to develop major depression than the general population. The goal of Sanofi, which markets MS drugs Aubagio and Lemtrada, is to not only maximize MS patients’ physical health, but also mental health.
The base software platform from Happify Health is already used for a non-specific solution in anxiety and depression with four million users. Sanofi worked with Happify to incorporate the specific medical and scientific needs and considerations around MS.
“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 said, adding that the move forward with this digital therapeutic will test “whether there are specific improvement in MS symptoms before making value propositions.”
The timeline for the app depends on the FDA and what level of evidence it will require once Sanofi and Happify submit, he said. However, the FDA has signaled its general willingness to consider and approve digital therapies with its proactive Digital Health Software Precertification (Pre-Cert) Program. The first FDA-approved digital therapeutics was Pear Therapeutics’ reSET app to treat substance abuse, launched in partnership with Novartis’ Sandoz last year.
While this is Sanofi’s first move into digital therapeutics, it won’t be the last. Nathwani said the company has a list of 10 disease areas it would like to consider.
“This is a first foray, but we’re certainly talking to other companies about digital therapy approaches in other diseases. So yes, we see how 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,” he said.