Real-world data is increasingly important to decision makers as it provides insights and data on patient populations, clinical practice and drugs from sources other than prospective clinical trials.
 
“ISPOR is a key conference for payers, policy makers, healthcare providers, patient organizations and industry players. This abstract acceptance is an opportunity to share data on the patient vulnerability and unmet need for Orviglance® with these key stakeholders. The real-world data support the commercial potential for Orviglance and is valuable in the dialogue with potential commercialization partners,” says Julie Waras Brogren, Deputy CEO of Ascelia Pharma.
 
The real-world data show that the target patient population for Orviglance, i.e. patients with liver cancer and kidney impairment, had more abdominal imaging procedures both in comparison to those without kidney impairment and to those with other cancers.
 
The data also show that target patients for Orviglance typically have several co-morbidities, such as diabetes and hypertension, and higher overall medical costs.
 
This real-world study used retrospective US patient claims datasets over 24 months, including Medicare data. The study compared demographics, imaging procedures, co-morbidities and use of healthcare resources for 230,000 cancer patients, of which 5% had liver cancer (primary or metastases) and of these 3,8% had severe kidney impairment, and 23.9% acute kidney injury during the 24-month period.
 
Ascelia Pharma expects to submit the New Drug Application (NDA) file for Orviglance to the US Food and Drug Administration (FDA) by mid-2025 to obtain regulatory approval.