Pharming Group N.V. (PHAR) Thursday said the UK's Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Joenja to treat individuals aged 12 years and older with activated phosphoinositide 3-kinase delta syndrome (APDS), a genetic disorder that impairs the immune system.
The MHRA evaluated the Marketing authorization Application (MAA) for leniolisib through the International Recognition Procedure (IRP) pathway on the basis of the U.S. Food and Drug Administration approval received in March 2023, the company said in a statement.
The drug is under evaluation by the National Institute for Health and Care Excellence (NICE) regarding reimbursement within the National Health Service (NHS) in England.
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