Request for FDA Approval: Prescription Digital Therapeutic Targeting Liver Disease With Breakthrough Device Designation

In January 2024, Better Therapeutics, Inc. submitted a request to the US Food and Drug Administration (FDA) for Breakthrough Device Designation for its new prescription digital therapeutic (PDT) designed to treat metabolic dysfunction-associated steatotic liver disease (MASLD) and metabolic dysfunction-associated steatohepatitis (MASH). According to the press release, “AspyreRx (formerly BT-001) was granted marketing authorization by the FDA in July 2023 as the first prescription-only digital therapeutic to treat adults with type 2 diabetes (T2D)”¹

“Securing Breakthrough Device Designation from the FDA has the potential to accelerate the expansion of our digital therapeutics platform beyond type 2 diabetes,” said Frank Karbe, president and CEO at Better Therapeutics. “The versatility of our therapeutic approach across a broad spectrum of cardiometabolic conditions is an exciting and unique aspect of our platform. Furthermore, the digital nature of our products allows for potential expansion in a fraction of the time and cost compared to traditional drug development.”¹

MASLD affects a significant percentage of US adults, estimated to be around 25% to 30%. This includes approximately 70% of individuals with T2D and up to 90% of those with obesity. The more severe form of MASLD, known as MASH, affects approximately 5% to 11% of American adults and has recently become a primary reason for liver transplant. Despite this, there are currently no treatments approved by the FDA for MASLD, whether in the form of drugs or devices. Behavioral modification is the recommended first-line treatment in clinical practice guidelines to help address the root causes and cardiometabolic comorbidities associated with MASLD and MASH.¹

The company's LivVita Liver Study showed efficacy in reducing liver fat within 90 days and improving liver health with no safety concerns.²

“As a physician dedicated to addressing the complexities of metabolic disorders, witnessing the reduction in liver fat and enzymes within a short timeframe through this digital therapy is not only promising, but represents a groundbreaking advancement to use technology to help facilitate evidence-based treatment,” said Naim Alkhouri, MD, director of the Fatty Liver Program at Arizona Liver Health and Principal Investigator of the study. “This innovation has the potential to offer effective and scalable support that can make a meaningful impact on those living with MASLD and MASH.”¹

Viewpoints from Health Care Providers and Patients About Prescription Digital Therapeutics^3,4

Health care provider stated, “Digital therapeutics really allow us to offer guideline-consistent care, which is typically behavioral interventions like cognitive behavioral therapy or CBT in digital formats, and as pure software, because they're fully automated and there's really no need for human intervention, they can really be offered at scale to everyone in need.”

Medical doctor stated, “The notion of prescription digital therapeutic is that instead of prescribing yet another drug to help those types of patients, they're going to prescribe an FDA regulated mobile medical app, a prescription digital therapeutic, which is easy to fill, and it comes directly onto the patient's smartphone.”

Patient stated, “Already seeing positive improvement in my routines thanks to this app.”

References

1. Better Therapeutics. Better Therapeutics announces submission for FDA breakthrough device designation for digital therapeutic platform to treat liver disease. News release. Published January 2, 2024. Accessed January 19, 2024. https://investors.bettertx.com/news-releases/news-release-details/better-therapeutics-announces-submission-fda-breakthrough-device
2. Alkhouri N, Edwards K, Berman M, et al. A novel prescription digital therapeutic option for the treatment of metabolic dysfunction-associated steatotic liver disease. Gastro Hep Adv. 2024;3(1):9-16. doi:10.1016/j.gastha.2023.08.019
3. American Psychological Association. Policy challenges and opportunities for digital therapeutics in the mental health and substance use crisis. Published April 6, 2022. Accessed January 19, 2024. https://www.apa.org/members/content/digital-therapeutics-transcript.docx
4. Empowered Patient Podcast. Using prescription digital therapeutics to treat diseases related to health behavior with Dr. Mark Berman Better Therapeutics. Published May 18, 2022. Accessed January 19, 2023. https://empoweredpatientradio.com/using-prescription-digital-therapeutics-to-treat-diseases-related-to-health-behavior-with-dr-mark-berman-better-therapeutics