Anurag Relan, Chief Medical Officer of Pharming, commented:
"This MAA submission, under an accelerated regulatory pathway, is an important step towards approval of our second product in the EEA and highlights Pharming's ongoing commitment to advancing leniolisib as a treatment for patients with APDS. There is a significant unmet need for therapies to improve outcomes for these patients, which, if left untreated, can result in permanent lung damage and lymphoma. Leniolisib has the potential to be the first approved treatment for this rare and orphan-designated disease, and we look forward to continuing our work with key stakeholders to bring this new product to patients."