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EMA Considers Accelerated Review Of Madrigal’s NASH Drug Filing, Discloses Other Fast-Track Decisions

 
• By Neena Brizmohun

Resmetirom, for noncirrhotic non-alcoholic steatohepatitis, is among the investigational products that the European Medicines Agency has been considering for review under its accelerated assessment pathway.

Calendar
The accelerated assessment mechanism can cut months off the standard review timeline • Source: Shutterstock

The European Medicines Agency was this week due to decide whether to fast track the planned EU marketing authorization application (MAA) for resmetirom, Madrigal Pharmaceuticals’ drug candidate for noncirrhotic non-alcoholic steatohepatitis (NASH), which could potentially become the first licensed therapy for the disease.

The agency also disclosed this week that it would fast track the planned MAAs for Pfizer/AbbVie’s aztreonam-avibactam and MSD’s sotatercept, but that it had rejected requests for the accelerated assessment of

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More from Geography

EU Shaping Biotech Act To Unleash SME Potential

 
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European companies, in particular small and midsize enterprises, spin-offs and start-ups have a hard time expanding within the single market “because of a complex regulatory framework that is perceived as slow and burdensome,” according to the European Commission.

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