PHAR - Pharming gets promising innovative medicine status in UK for leniolisib to treat rare immunodeficiency disorder

Pharming Group (NASDAQ:PHAR) said the U.K.'s Medicines and Healthcare Products Regulatory Agency (MHRA) granted promising innovative medicine (PIM) designation to leniolisib to treat activated phosphoinositide 3-kinase delta syndrome (APDS), a rare immunodeficiency disease. The company added that it also received a positive decision from the MHRA on a Paediatric Investigation Plan (PIP) submission for leniolisib to treat APDS in patients ages 1-year to less than 18 years of age. Pharming (PHAR) noted that a PIP is a development plan aimed at ensuring that the necessary data is obtained to support the marketing authorization of a medicine for use in children. The company said leniolisib PIP includes two planned global trials, the first in children ages 4-11 years and the second in children ages 1-6 years with APDS. The company expects to begin recruitment for the program in H2 2022. Pharming (PHAR) plans to begin submitting global registration filings for leniolisib in Q2 2022 and,

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Pharming gets promising innovative medicine status in UK for leniolisib to treat rare immunodeficiency disorder