The passenger schreef op 4 augustus 2022 07:34:
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Exact, 2 * Janssen, cijfers keurig in lijn met de verwachtingen, alhoewel ik de toename van marketing / sales kosten niet helemaal begrijp, maar goed in aanloop naar.
Concerning pipeline development, we continued to advance leniolisib through the regulatory process as we seek marketing authorization in the US, the UK, and the EEA for the treatment of APDS, a rare, complex and progressive primary immunodeficiency.
In the US, we filed a New Drug Application with the FDA for the treatment of APDS in adults and adolescents aged 12 or older at the end of July 2022. On August 2, we announced a new diagnosis code for reporting cases of APDS, which will be added to the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) by the US Centers for Disease Control and Prevention (CDC). The diagnosis code, D81.82, will be effective starting October 1, 2022.
En dat men tussen de regels verwacht in aanmerking te komen voor priority review:
Subject to FDA approval and granting of priority review by the FDA in the US, we remain on track for the commercial approval of leniolisib in the first quarter and market launch early in the second quarter of 2023.
On July 29, 2022, a New Drug Application (NDA) was submitted to the US FDA for leniolisib, for the treatment of activated phosphoinositide 3-kinase delta (PI3Kd) syndrome (APDS) in adults and adolescents aged 12 or older. Aligned with the goals set out in PDUFA VI, Pharming expects a Filing Notification Letter by Day 60, which will include the FDA’s determination of priority review. If priority review is granted, it is expected that the FDA review will be completed within six months of the 60-day filing date.
In anticipation of a positive outcome
Salut