Accelerated Assessment Dry Spell Over As EMA Says Yes To Pharming’s Leniolisib
MAA Filing Is Planned In October
Leniolisib has become the first product to be granted accelerated assessment status by the European Medicines Agency this year.
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The Dutch firm has announced its intention to submit US and EU filings for leniolisib and expand development into Japan after the candidate impressed in an ultra-rare disease study.
It’s hard enough in the first place for companies to persuade the European Medicines Agency that their planned marketing authorization application should be fast-tracked. Many are also finding that after accelerated assessment is granted, it is taken away during the actual review.
Companies have the opportunity to tell the European Commission what they think about its proposed regulation that would overhaul the rules governing the use of substances of human origin.