EU Accelerated Assessment Tracker
Alnylam and Eiger join the select group of companies whose products have been granted fast-track status at the European Medicines Agency
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The European Medicines Agency has agreed to fast track the review of four marketing applications in recent months.The products include AstraZeneca's advanced breast cancer treatment, Enhertu, two investigational CAR-T therapies, and a potential treatment for rare genetic disorders of obesity.
EU sponsors of two investigational drugs – one to treat the rare genetic Pompe disease and the other for patients with severe inherited form of high cholesterol – have requested a speedy review of their respective marketing applications.
Applications to market Roche’s spinal muscular atrophy drug have already been submitted in eight countries including the US, where a decision is due in August.