Pharming leniolisib assessment converted to accelerated word standard as EMA looks for more data
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A panel of the European Medicines Agency (EMA) converted Pharming’s assessment (NASDAQ:PHAR) leniolisib for standard review from the rapid review when the committee sent questions to the company, including a request for more data.
Corporate Marketing Authorization Application (MAA) for leniolisib To be accuracy for assessment under the EMA Committee on Human Medicinal Products (CHMP) rapid review in October 2022.
The company is seeking approval for leniolisib to treat patients 12 years of age and older with activated delta phosphoinositide 3-kinase (PI3K) syndrome (APDS), a rare primary immunodeficiency disorder.
The Netherlands-based company said it received a list of inquiries from the EMA, which included a request to submit updated data from an ongoing long-term extension study collected after analysis. temporarily included in the original MAA.
Pharming expects that the CHMP will issue its opinion on leniolisib MAA in the second half of 2023.
“We are continuing to work with EMA through the MAA review process and remain dedicated to seeking regulatory approval for leniolisib within the European Economic Area. In the United States, the review process prioritizes FDA’s NDA leniolisib is still on track, with the PDUFA target date of March 29, 2023,” speak Pharming CEO Sijmen de Vries.
FDA has given priority review to leniolisib in September 2022.
APDS is a rare immunodeficiency disease that affects 1 to 2 people per million and is caused by variants in one of two genes, PIK3CD or PIK3R1, which regulate the maturation of white blood cells. , according to the company.
