Pentixapharm's Ga68-PentixaFor wins EMA PRIME status

On Tuesday, the European Medicine Agency (EMA) awarded PRIME status to Pentixapharm's leading radiodiagnostic agent Ga68-PentixaFor, signaling a potential fast-track towards accelerated approval. This designation is aimed at expediting the development and review of drugs that address unmet medical needs, such as primary aldosteronism (PA), a condition for which Ga68-PentixaFor has shown promise.

Ga68-PentixaFor is a novel tracer for positron emission tomography (PET) imaging, which targets 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.

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.

The PRIME scheme, established by the EMA in 2016, 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. With Ga68-PentixaFor, only 139 applications have received PRIME designation, and it is noteworthy as the first radiopharmaceutical to achieve this status.

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.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

Source: Investing.com