Spanish pharmaceutical company, PharmaMar, announced on the 5th of August that their product Zepzelca® (lurbinectedin) was awarded an Innovation Passport by the UK’S Medicines and Healthcare Products Regulatory Agency (MHRA).
The MHRA awards Innovation Passports to those products it deems innovative, in order for them to be assessed via the Innovative Licensing and Access Pathway (ILAP). The ILAP aims to accelerate time to market for these products, allowing patients faster access to life-saving or life-changing medicines.
The criteria for an Innovation Passport include targeting a life-threatening or seriously debilitating condition where there is significant unmet need, and where the product can offer benefit to patients in terms of improved efficacy, safety or quality of life compared to the current alternative treatments.
Zepzelca® inhibits active transcription of protein-coding genes, triggering DNA breaks and apoptosis. It is an analogue of trabectedin, which was originally isolated from the marine organism ecteinascidia turbinate. In May 2022, a conditional marketing authorisation assessment was submitted to the MHRA for the treatment of metastatic small cell lung cancer in adult patients who have progressed on chemotherapy.
PharmaMar https://pharmamar.com/en/lurbinectedin-receives-the-innovative-medicine-designation-by-the-uks-mhra/ Accessed 8th August 2022