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Accelerated Assessment Dry Spell Over As EMA Says Yes To Pharming’s Leniolisib

MAA Filing Is Planned In October

 
• By Neena Brizmohun

Leniolisib has become the first product to be granted accelerated assessment status by the European Medicines Agency this year.

The EMA will fast-track its review of leniolisib • Source: Alamy

The European Medicines Agency has agreed to fast-track Pharming Groups planned EU marketing authorization application (MAA) for leniolisib, making the investigational drug for treating the rare immunodeficiency, APDS, the first product to be granted an accelerated assessment by the regulator this year.

Pharming plans to submit its MAA for leniolisib to the EMA in October 2022. It believes the drug could potentially...

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