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AB Science & Daiichi Try Their Luck Again With EU Filings

 
• By Neena Brizmohun

The sponsors of Alsitek and quizartinib are hoping that new data generated for the drugs will resolve the concerns raised by the European Medicines Agency when it previously rejected the products for marketing in the EU.

Astrocyte and blood vessel
Alsitek is an investigative treatment for the fatal motor neuron disorder, ALS • Source: Shutterstock

The European Medicines Agency has begun reviewing new EU marketing authorization applications (MAAs) for two drugs it had previously rejected – Alsitek (masitinib) and quizartinib – and a product that was approved but then withdrawn for commercial reasons – catumaxomab.

Alsitek, from AB Science, and quizartinib, from Daiichi Sankyo, are for treating amyotrophic lateral sclerosis (ALS) and acute myeloid leukemia (AML) respectively. Catumaxomab is a cancer drug whose EU sponsor’s identity is not yet clear

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