Aurinia has filed a New Drug Application (NDA) for voclosporin under priority review and is working towards launch readiness with a potential commercial launch in the first quarter of 2021
MyMeds&Me has today announced Aurinia Pharmaceuticals has selected the Reportum QuickStart platform to streamline the capture, processing and management of safety data for the investigational drug voclosporin, following recent positive Phase 3 results.
Aurinia will implement the Reportum QuickStart platform to support the launch of voclosporin, enabling adverse event, product quality complaint, and medical information requests to be captured by field-based representatives, medical science liaisons and speciality pharmacy providers, as well as direct from healthcare professionals and consumers.
Offering the full safety data capture functionality of the Reportum platform, which is already in high volume use by pharma companies, QuickStart is a preconfigured and validated solution to facilitate rapid set-up and cost-effective deployment. Using MyMeds&Me’s industry experience, QuickStart enables pharmacovigilance teams of all sizes to benefit from a drug safety system that can be implemented within a matter of weeks.
“We are excited to work with MyMeds&Me to streamline our pharmacovigilance processes with the Reportum QuickStart platform” said Dr Neil Solomons, Chief Medical Officer of Aurinia. “We are advancing voclosporin as a potential first-in-class therapy for the treatment of lupus nephritis. Implementing an efficient method to capture robust product safety data in a timely manner is an essential step along that journey.”
“Reportum QuickStart provides Aurinia with a centralised solution to capture data, including direct from consumers and healthcare professionals” said Dr Andrew Rut, founder and CEO of MyMeds&Me. “By harmonising the capture of adverse events across intake routes and making the data available for prompt analysis, Aurinia are able to analyse their data rapidly and potentially accelerate safety insights.”