Partnership Aims for FDA-approved App That Aids Mental Health in MS, Sanofi Announces

Sanofi is working with Happify Health to develop an app that addresses the mental health of people with multiple sclerosis (MS) through cognitive behavior therapy.

The physical symptoms of MS, such as fatigue and spasticity, are well-documented. But many patients also struggle with bouts of depression, anxiety and the like, affecting their sense of well-being, life quality and, potentially, adherence to treatment.

“Many … face significant burdens, and we have an obligation to help them not only maximize their physical health, but their mental health as well,” Bozidar Jovicevic, Sanofi’s global head of digital medicine, said in a press release.

“Through its collaboration with Happify Health, Sanofi aims to provide real-time, constant support for mental health conditions, and improve quality of life,” added Ameet Nathwani, Sanofi’s chief medical officer and chief digital officer.

Clinical studies are being planned to test whether the app, via education and other activities, would benefit the mental health of its users.

Should trial results be positive, Sanofi and Happify plan to seek regulatory clearance from the U.S. Food and Drug Administration to market the app as a medical device. Such a process involves more rigorous quality testing, privacy protection, and security aspects is common for apps, which often do not go through rigorous and scientific testing.

If the FDA’s approval is given, the app would be available by prescription.

Digital therapeutics are software solutions to help prevent diseases and improve their treatment. They may be used independently or as an add-on to medications, other devices, or approaches to optimize clinical outcomes.

Increasingly broad use of smartphones and computers is key, Ofer Leidner, Happify’s co-founder and president said, as these tools help to introduce “new self-care and augmented-care delivery models that are dynamic, highly personalized and engaging.”

“We have found that our collaboration is ideal for the development of technologies with the potential to change our approach to anxiety and depression for people living with MS,” Leidner added.

The partnership looks to combine Sanofi’s expertise in MS with Happify Health’s skills in developing digital platforms aiming for greater efficacy, safety, and patient engagement.

“Our differentiation,” said Chris Wasden, head of digital therapeutics at Happify, “is in providing proven, efficacious digital therapies that fit seamlessly with pharmaceutical therapies to offer a true ‘beyond the pill’ experience for patients.”

“Our interventions are tested in randomized clinical trials and published in peer-reviewed journals, testaments to our commitment to putting forward only evidence-based, safe and effective digital therapies,” Wasden added.

This project is part of Sanofi’s broader work on digital health innovations that include software- and hardware-based interventions, as well as virtual healthcare.

“We are working to create a future where rigorously vetted digital therapeutics can create behavioral change and work alongside traditional approaches to continue our focus on treating people holistically so they can live a better life,” Jovicevic concluded.