EMA’s PRIME Offers Hope To Advanced Therapies As More Get A “Yes”
Juno Therapeutics and bluebird bio are the latest companies to get accepted on the European Medicines Agency’s PRIME (priority medicines) scheme with their advanced therapy medicinal products. ATMPs are now the most common type of product on the scheme, and help is coming for developers trying to navigate Europe’s notoriously challenging ATMP framework.
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Bluebird Bio and Celgene have secured a place on both the EMA’s PRIME scheme and the US FDA’s breakthrough therapy designation program for their multiple myeloma CAR-T therapy, bb2121. Meanwhile, Bluebird talks about how “incredibly helpful” PRIME has been with the development of LentiGlobin for beta-thalassemia.
The European Medicines Agency's action plan to support the development of advanced therapy medicinal products will prioritize on actions that are feasible, will result in major gains without the need for a lot of effort and will not require legislative changes.
The European Medicines Agency has told the Pink Sheet about the common mistakes companies are making in their bid to enter its popular priority medicines (PRIME) scheme. Meanwhile, applicants that have succeeded in getting accepted for the scheme talk of "convivial" and "efficient" discussions with the agency.