Faron - UK/ viranomaiset
https://www.nordnet.fi/markkinakatsaus/uutiset/1d778cce-74e5-4572-9af8-1f4a333acbef
UK-viranomaiset jouduttavat BEXin käyttöönottoa ja potilaiden rekrytointia UK:ssa. Työ käynnistetään heti.
"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)."
UK:n säätelyviranomainen MHRA esitteli 2021 potlaille tarjottavan, nopeutetun pääsyn, ILAP-prosessin, ensiluokan hoitoihin. Nyt tämä koskee bexmarilimabin testausta r/r MDS:iin.
"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."
Päätös 'keksintöpassista' tehtiin johtoryhmässä (MHRA, NICE, AWTTC ja SMC) ja perusteluina oli lääkkeen korvaamattomuus ja sen myöntämisen tarkoitus oli jouduttaa lääkkeen kehittämistä ja hyväksyttämistä..
"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'spotential to address significant unmet medical needs and positions the therapy for faster development and potentially earlier access for patients."
Lisäksi Faron on saanut luvan kokeiden järjestämiseksi UK:ssa.
"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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