Accelerated Assessment Dry Spell Over As EMA Says Yes To Pharming’s Leniolisib
MAA Filing Is Planned In October
Executive Summary
Leniolisib has become the first product to be granted accelerated assessment status by the European Medicines Agency this year.
You may also be interested in...
Pharming Leniolisib Launch Will Require Identifying Patients With Ultra Rare APDS
The company sees leniolisib as a way to expand its US and global commercial footprint before bringing in additional rare disease assets.
New EU Filings Include First Self-Administered Treatment For Myasthenia Gravis
UCB’s zilucoplan for treating gMG is among the latest new drugs that the European Medicines Agency has started reviewing for potential EU marketing approval.
Pharming’s Leniolisib On Track To Become First Disease-Modifying APDS Drug
The Dutch firm’s US filing for its first-in-class PI3K inhibitor has been accepted under priority review, bringing the asset closer to becoming the first disease-modifying option for a rare, genetic disorder.