RE: No RNS Showing2 Dec 2024 09:02
TURKU, FINLAND ‐ Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical‐stage biopharmaceutical company
focused on tackling cancers via novel immunotherapies, today announces that the BEXMAB Study may proceed in the UK and
bexmarilimab has received an Innovation Passport, under the Innovative Licensing and Access Pathway (ILAP) from the UK's
Medicines and Healthcare products Regulatory Agency (MHRA), for the treatment of relapsed/refractory Myelodysplastic Syndrome
(r/r MDS).
The ILAP was introduced by the MHRA in 2021 to give patients quicker access to cutting‐edge treatments and therapies for life‐
threatening or seriously debilitating conditions, or conditions for which there is a significant patient or public health need. The
benefits of the ILAP include enhanced regulatory support from the MHRA and provides collaborative opportunities with health
technology assessment bodies and other stakeholders, with the aim of accelerating the development, and improving patient
access to promising new medicines.
The decision to award the Innovation Passport to bexmarilimab was made by the ILAP Steering Group, which is comprised of
representatives from the MHRA, NICE, AWTTC and SMC, and provides further regulatory verification of bexmarilimab's potential to
address significant unmet medical needs and positions the therapy for faster development and potentially earlier access for
patients.
In addition, Faron today announced that it has received regulatory approval from the MHRA to conduct the BEXMAB trial in the UK.
This approval will allow Faron to recruit UK haematology patients directly, accelerating its research efforts by increasing
recruitment and enhancing the study's diversity and scope by expanding the participant pool.
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