Pharming (PHAR) said Tuesday that its Joenja drug has received approval from Japan's Ministry of Health, Labour and Welfare to treat activated PI3K delta syndrome, or APDS, a rare primary immunodeficiency, in adult and pediatric patients aged over 4 years.

The company said it expects to launch Joenja after reaching an agreement with Japan's Ministry of Health, Labour and Welfare on its National Health Insurance drug price.

Pharming said that following approval, Joenja is the first treatment approved in Japan specifically for APDS. It is also the first approved treatment globally for children with the disease aged four to eleven, it said.

The approval was based on data from Pharming's phase 3 study evaluating the drug in APDS, the company said.