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Pharming’s Leniolisib On Track To Become First Disease-Modifying APDS Drug

Following NDA Acceptance

 
• By Ayisha Sharma

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.  

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Pharming Seems To Be The Only Firm Working On A Drug For APDS • Source: Shutterstock

Pharming Group N.V.’s new drug application for leniolisib in activated phosphoinositide 3-kinase δ syndrome has been accepted by the US Food and Drug Administration under a priority review, meaning the candidate could enter a vacant market early next year.

The NDA was filed in July for patients aged 12 or older and the FDA has set a user fee date of 29 March 2023. The submission contains data from the Phase II/III trial of leniolisib in activated phosphoinositide 3-kinase δ syndrome (APDS)

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