TURKU, FINLAND - Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a biopharmaceutical company, announced today that its drug bexmarilimab has been awarded an Innovation Passport by the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of relapsed/refractory Myelodysplastic Syndrome (r/r MDS). The company also received approval to expand the BEXMAB clinical trial into the UK.
The Innovation Passport is part of the Innovative Licensing and Access Pathway (ILAP), established by the MHRA in 2021. This pathway aims to accelerate the development and patient access to promising new medicines for life-threatening or seriously debilitating conditions, or where there is significant patient or public health need.
Bexmarilimab's receipt of the Innovation Passport follows a positive evaluation by the ILAP Steering Group, which includes representatives from the MHRA, NICE, AWTTC, and SMC. This recognition underscores the therapy's potential to meet a significant unmet medical need and may lead to faster development and earlier patient access.
In parallel with the Innovation Passport, Faron has obtained regulatory approval to conduct the BEXMAB trial in the UK. This approval is expected to hasten the research process by facilitating the recruitment of UK haematology patients, thereby increasing the trial's recruitment rate and enhancing its diversity and scope.
Dr. Juho Jalkanen, CEO of Faron, expressed satisfaction with the MHRA's recognition of bexmarilimab's potential and the opportunity to expedite its development. He highlighted the importance of regulatory engagement and the promising data supporting bexmarilimab's efficacy in treating r/r MDS patients. With the ILAP designation and the trial's expansion to the UK, Faron anticipates providing UK patients with access to this novel therapeutic option and intends to continue discussions with the MHRA to further accelerate bexmarilimab's path to market.
The information in this article is based on a press release statement from Faron Pharmaceuticals.
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