The European Medicines Agency (EMA) has awarded PRIME status to Pentixapharm's lead radiodiagnostic agent, Ga68-PentixaFor, signaling a potential fast track towards accelerated approval for diagnosing primary aldosteronism (PA). This designation aims to expedite the development and review of drugs that address unmet medical needs, offering a non-invasive alternative to current diagnostic methods.
Targeting CXCR4 in Primary Aldosteronism
Ga68-PentixaFor is a novel tracer for positron emission tomography (PET) imaging, specifically targeting the C-X-C receptor 4 (CXCR4). This receptor is highly expressed in aldosterone-producing tissue, which is implicated in PA by causing an over-secretion of aldosterone. The tracer is being developed as a non-invasive and accurate alternative to the current invasive standard of care, adrenal venous sampling (AVS), with the potential to revolutionize the diagnostic subtyping in PA.
Benefits of PRIME Designation
The PRIME status confers several benefits to Pentixapharm, including the early appointment of rapporteurs from the Committee for Medicinal Products for Human Use (CHMP) or the Committee for Advanced Therapies (CAT), as well as iterative scientific advice for development plans. Additionally, Pentixapharm may receive an introductory meeting on regulatory requirements and potentially a total fee exemption for scientific advice.
Established by the EMA in 2016, the PRIME scheme fosters enhanced interaction between the regulatory body and the drug sponsor to optimize drug development. It allows for expedited scientific advice, shortened timelines for follow-up advice, and the possibility of an accelerated assessment when applying for marketing authorization. Only 139 applications have received PRIME designation, with Ga68-PentixaFor being the first radiopharmaceutical to achieve this status.
Addressing an Unmet Need in Hypertension
Primary aldosteronism, also known as Conn’s syndrome, is the most common cause of secondary hypertension but is challenging to diagnose and treat effectively with existing methods. Pentixapharm is preparing for a Phase III pivotal study, scheduled to commence in 2025, which is a critical step in obtaining marketing authorization for Ga68-PentixaFor in the treatment of PA.
