– Companies plan to seek FDA clearance for digital therapeutics approach –

The list of physical symptoms of multiple sclerosis (MS) is long and varied, including fatigue, numb limbs and tremors. But many people living with MS also experience mental health conditions — particularly depression and anxiety. People with MS develop a form of major depression at a rate two to five times higher than the general population, depending on the country studied.

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

Sanofi is collaborating with Happify Health, which provides evidence-based mental health digital therapeutics, to develop and study an app to help manage and improve psychological outcomes in people with MS.

Digital therapeutics (DTx) deliver to patients evidence-based therapeutic interventions to patients that are driven by high quality software programs to help prevent, manage, and treat a medical disorder or disease. They are used independently or in concert with medications, devices, or other therapies to optimize patient care and health outcomes. Investment in such approaches is part of a broader strategic effort at Sanofi, which includes digital health innovations, such as software- or hardware-based interventions, virtual health care and partnerships with solution providers with the goal of improving outcomes and the patient experience.

Studies have shown that poor mental health during an MS journey has been associated with reduced quality of life and decreased treatment adherence.

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

The collaboration will create — and study via clinical trials — an app that introduces cognitive behavior therapy to help improve mental health through education and other activities.

Patients are getting more interested in their own health and are looking for solutions. Developing technologies that can potentially help support their mental health management can be a perfect complement to traditional therapies,” Nathwani said.

Based on randomized clinical trial results, Sanofi and Happify aim to submit the app for U.S. Food and Drug Administration for clearance, subjecting it to a regulatory process for software as a medical device. This process includes more rigorous quality testing, privacy protection and security considerations than ordinary consumer apps undergo. If FDA clears the app, it would be available by prescription.

The ubiquity of smartphones and PCs has the potential to introduce new self-care and augmented-care delivery models that are dynamic, highly personalized and engaging,” said Ofer Leidner, co-founder and president of Happify Health.  “Further, our evidence-based digital platform is designed to maximize efficacy, safety and patient engagement at scale, three areas which are difficult to attain with one solution.

Just as molecular understanding and adherence create the biologic basis for effective drug-based therapy, medical understanding and engagement provide the keys to success with a digitized cognitive behavior therapy program. This collaboration will marry Sanofi’s patient focus and medical and scientific expertise in MS with Happify Health’s skill in creating platforms designed for maximum engagement.

This new intersection between tech companies and pharmaceutical companies requires a real effort to learn together, to build a new interface between industries,” Leidner said. “Sanofi has demonstrated a commitment to digital transformation, and 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.

While there is no shortage of digital mental health interventions, our differentiation is in providing proven, efficacious digital therapies that fit seamlessly with pharmaceutical therapies to offer a true ‘beyond the pill’ experience for patients,” said Chris Wasden, Ed.D., Head of DTx, Happify Health.  “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.

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 said.