Pharming Group (PHAR) said Thursday the US Food and Drug Administration has accepted resubmitted supplemental marketing application of its drug, Joenja, for children aged four to 11 with activated phosphoinositide 3-kinase delta syndrome, a rare immune disorder.

The company said the FDA is expected to make a decision by Oct. 24.

The drug developer said the resubmission follows a complete response letter received in January and includes additional manufacturing-related data requested by the agency.

Pharming also said it plans to submit a separate application this summer for lower-dose use in children weighing less than 27 kilograms.

The application is supported by a phase 3 study showing that Joenja improved key signs of activated phosphoinositide 3-kinase delta syndrome over 12 weeks, including reduced lymph node enlargement and increased levels of naive B cells, indicating improved immune function, it added.