As the European Medicines Agency gets on with its fast-track review of bluebird bio's LentiGlobin gene therapy, the Pink Sheet takes a look at the year so far in the area of accelerated assessment. Daiichi Sankyo is keeping us guessing on whether its investigational new product, quizartinib, will also be fast-tracked once filed.
Bluebird bio’s filing of a marketing authorization application (MAA) with the European Medicines Agency for its LentiGlobin gene therapy for the treatment of patients with transfusion-dependent β-thalassemia (TDT) brings to five the number of products being reviewed under the agency’s accelerated assessment mechanism.
The US company announced on Oct. 5 that the EMA had accepted its MAA for LentiGlobin in this indication under the fast-track mechanism, which can reduce the active review time...
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Vyjuvek, Krystal Biotech's advanced therapy for treating dystrophic epidermolysis bullosa.
Sponsors can expect faster evaluation processes for key medicines and greater support in mitigating medicines supply shortages this year as part of the European Medicines Agency’s digital transformation overhaul.
The European Medicines Agency’s chief medical officer Steffen Thistrup argued that patients are able to understand the “complex regulatory and scientific issues” that the EMA committees discuss when they assess drugs.
