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Pharming Group, has been granted a positive opinion by EMA for its Paediatric Investigation Plan for leniolisib.
Commercial-stage biopharmaceutical company, Pharming Group, has been granted a positive opinion by the European Medicines Agency (EMA) for its Paediatric Investigation Plan (PIP) for leniolisib.
Leniolisib is a phosphoinositide 3-kinase (PI3K) inhibitor that Pharming is currently developing for the treatment of activated PI3K delta syndrome (APDS). So far, patients aged 12 years and older have been included in the ongoing registration of the Phase II/III study evaluating the therapy. However, as APDS affects younger children as well, the PIP, that has been agreed upon by EMA, will enable the company to enroll children as young as one-year old in future studies.
Once the agreed upon PIP has been successfully completed, the market exclusivity for leniolisib could be extended for a further two years in the European Union, which would be on top of the original 10-year market exclusivity the therapy has as a result of its EU Orphan Drug Designation. The company anticipates the top-line data from the Phase II/III registration in the first quarter of 2022.
“We are pleased to have received a positive PIP decision from EMA and accomplish this important regulatory milestone as we continue to advance leniolisib for the treatment of APDS in Europe as well as globally,” said Anurag Relan, chief medical officer of Pharming in a Jan. 6, 2022 press release. “The approval of the PIP further supports our confidence in the potential of leniolisib to address this orphan disease and population and provides us with a pathway towards marketing approval in Europe, in parallel with our [United States] regulatory strategy. Moving forward, we look forward to continuing to work with the regulatory authorities to bring leniolisib to the European market as expeditiously as possible.”