Daiichi Sankyo’s European faction and health technology company GAIA have banded together to commercialise a digital therapeutic designed to support adults with hypercholesterolaemia.
Under the terms of the agreement, Daiichi will claim the exclusive rights to the tool – called lipodia – marking the first potential expansion of the company’s cardiovascular portfolio into the digital health market. The partnership will originally centre around the German healthcare market, though Daiichi plans to expand lipodia’s presence to “all major markets on the continent”.
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Lipodia acts by combining individually patient-tailored, evidence-based behavioural health and psychotherapeutic approaches to encourage users to make sustained and long-term changes to their lifestyle. The system is designed to complement a patient’s pharmaceutical treatment regimen, while promoting prolonged behavioural changes to improve health and reduce a patient’s risk of cardiovascular disease (CVD).
“Digital therapeutics represent an important next step in delivering holistic heart health,” said Oliver Appelhans, Daiichi’s head of EU speciality business. “By combining pharmaceuticals with evidence-based digital therapeutics, we can support patients beyond our medicines.”
To encourage broad uptake and access, Gaia is planning to submit a reimbursement application for lipodia when data from its pivotal Phase III trial on the tool becomes available. If approved, public health insurers would reimburse lipodia through Germany’s Digital Health Applications (DiGA) pathway.
Marrying drugs and digital tools
While effective medications to treat CVD have significantly improved patient outcomes, pharmacological approaches do not encourage long-term lifestyle changes. It is currently estimated that 80% of heart disease and stroke cases impacting European patients are preventable. This means that early intervention and educational programmes revolving around long-term lifestyle changes could help to reduce CVD’s chronic healthcare and patient burden.
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By GlobalDataThis has led several pharma companies to look into how they can combine digital health and education tools with their pharmaceutical treatments to further improve outcomes.
Within the cardiometabolic health sector, Novo Nordisk is exploring how it can partner with digital health companies to provide fitness and dietary advice alongside treatment with its flagship weight loss drug, Wegovy (semaglutide).
Meanwhile, Otsuka Pharmaceutical currently leads in terms of market share in regulator-approved digital health apps, holding 16% of global revenue. This is, in part, powered by Rejoyn, its app for patients with depression, which the Japanese pharma created and launched in collaboration with Click Therapeutics back in 2024. The app complements the company’s range of pharmaceutical options for major depressive disorder (MDD), including its approved add-on therapies, Rexulti (brexpiprazole) and Abilify (aripiprazole).
According to recent analysis from GlobalData, regulatory-approved apps are primarily driving the continued growth of the digital health segment, which is “still in its early stages”.
Regulators are also getting on board with digital health tools, with the US Food and Drug Administration (FDA) and the UK’s Medicines and Healthcare products Regulatory Authority (MHRA) both debuting respective policies to improve the uptake of digital health tools across the wider healthcare landscape.
