GAIA, the pioneer in evidence-based digital therapeutics and the global leader in the development of fully-automated therapeutics, and Daiichi Sankyo Europe, an innovative global healthcare company contributing to the sustainable development of society that discovers, develops, and delivers new standards of care to enrich the quality of life across the globe, announced an exclusive strategic partnership to commercialize lipodia upon regulatory approval.
This digital therapeutic is designed to support adults living with hypercholesterolemia. The comprehensive collaboration brings together GAIA’s long-standing expertise in developing clinically validated non-pharmacological interventions with Daiichi Sankyo’s highly scientific experience in cardiovascular risk management and health. Together, the partners - both members of the German Association of Research-Based Pharmaceutical Companies (vfa) - aim to address a persistent gap in chronic care: leveraging digital technologies to make a difference in patients’ lives by supporting sustainable, long-term behaviour change.
Under the agreement, Daiichi Sankyo Europe secures exclusive rights for lipodia, marking a strategic expansion of its cardiovascular portfolio into digital therapeutics. The partnership initially covers Germany as the largest European healthcare market and incorporates expansion mechanisms for all major markets on the continent. It reflects a growing recognition that holistic heart health requires integrated solutions that combine pharmacological treatment with evidence-based behavioural support. Cardiovascular diseases (CVD) remain Europe’s leading cause of death and are responsible for more than 10,000 deaths every day. Yet, 80% of heart disease and stroke are preventable. The major risk factors for CVD include high blood pressure, high cholesterol, diabetes, smoking, obesity and physical inactivity, with poor diet, excessive alcohol consumption, and stress further contributing to its prevalence. Grounded in the latest, evidence-based behavioural health science and combining it with top-of-class psychological and psychotherapeutic methods, lipodia adapts dynamically to individual patient needs through interactive dialogues. Comprehensive additional functionalities further support the integration of healthy routines into everyday life, helping patients translate intention into sustained action. Lipodia is a next-generation, fully-automated digital therapeutic, accessible on almost any connected device, enabling flexible, location-independent use.
Dr. Mario Weiss, CEO GAIA, said: “Digital therapeutics unlock a new dimension of cardiovascular care by addressing the behavioural and psychological factors that medication alone cannot solve. With lipodia, we are translating more than two decades of scientific, technological, and therapeutic expertise into a scalable solution for one of the most widespread chronic conditions. Through our partnership with Daiichi Sankyo Europe, we are in the best position to integrate this evidence-based digital therapy into routine care in the near future, achieving the reach, scientific credibility, and impact that patients and physicians expect.”
Oliver Appelhans, head of EU specialty business unit, Daiichi Sankyo Europe, said: “At Daiichi Sankyo, we care for every heartbeat. Our goal is to protect people from cardiovascular disease and help those who suffer from it, so they can enjoy every precious moment that life has to offer. Digital therapeutics represent an important next step in delivering holistic heart health. By partnering with GAIA, we are combining pharmaceutical excellence with evidence-based digital therapeutic innovation to support patients beyond our medicines. This collaboration reflects our patient-centric approach to develop new solutions that improve long-term outcomes.”
To ensure broad patient access, GAIA plans to submit lipodia for reimbursement as soon as the data from the pivotal phase 3 RCT are available. Upon approval, the digital therapeutic would be reimbursed by statutory health insurance through the DiGA pathway and prescribed by physicians as part of routine cardiovascular care in the third largest healthcare market in the world - significantly lowering access barriers for patients.
With cardiovascular disease remaining one of the leading causes of morbidity in Germany and beyond, the partnership positions lipodia as a scalable, evidence-based complement to established treatment pathways and reinforces Germany’s role as a leading market for regulated digital therapeutics.
GAIA’s product portfolio includes not only digital health applications (DiGA) but also numerous innovative therapeutics for mental health conditions, as well as other therapeutic areas such as immunology, rheumatology, MS, and back pain.
For over 25 years, GAIA has combined scientific, technological, and therapeutic expertise under one roof. Its goal is to support as many people as possible in restoring and maintaining their mental and physical health, thus improving their quality of life and well-being. The expert team at GAIA has confirmed the efficacy of its products in over 30 RCTs and meta-analyses. GAIA is the 48th member of the Association of Research-Based Pharmaceutical Companies (vfa).
With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular, and other diseases with high unmet medical need.
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