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Pharming To Branch Out Into Japan With Leniolisib Following Successful Pivotal Trial

 
• By Ayisha Sharma

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.  

Mt. Fuji with Shinkansen train and rice field at Shizuoka, Japan.
Pharming Is Considering Japan As Leniolisib Provides An Opportunity To Broaden Scope. • Source: Alamy

Pharming Group N.V..’s leniolisib has impressed in a Phase II/II APDS trial, sparking plans for US and EU regulatory filings in the second quarter of this year and encouraging the firm to delve into the Japanese market.

Leniolisib met the endpoints in a pivotal activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) study in patients aged over 12 years. APDS is an ultra-rare condition characterized by lymphoproliferation, immune dysfunction and increased risk of malignant lymphoma

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