The Saudi Food and Drug Authority (SFDA) has granted Bayer orphan drug designation to Hyrnuo (Sevabertinib), which is indicated for the treatment of adult patients with advanced non-squamous non-small cell lung cancer (NSCLC) who have received a prior systemic therapy.

Registration is Subject to Full Scientific Evaluation

The SFDA clarified that designation under the Orphan Drug Program does not constitute formal product registration. Instead, this designation permits the company to submit a marketing authorization dossier through a dedicated regulatory pathway intended for medicines targeting serious or rare diseases with promising preliminary results.

The final registration decision will be announced at a later stage, following the completion of a comprehensive technical evaluation in accordance with applicable regulations.

SFDA Orphan Drug Program Accelerates Access to Critical Therapies

This approval highlights the SFDA's commitment to enhancing access to treatments for rare and chronic diseases through the Orphan Drug Program, which is a strategic pillar for accelerating the provision of breakthrough therapies and addressing unmet medical needs. This initiative aligns with the objectives of the Health Sector Transformation Program, which aims to enhance the quality of healthcare within the framework of Saudi Vision 2030.

For further information about the Guidance for Orphan Drug Designation, please visit: https://www.sfda.gov.sa/en/regulations/88482