The U.S. Food and Drug Administration (FDA) on Friday approved Pharming Group's drug to treat a rare genetic disorder that leads to a weakened immune system, the Dutch company said.
Leniolisib, to be sold under the brand name Joenja, becomes the first approved drug in the United States to treat activated phosphoinositide 3-kinase delta syndrome , a primary immunodeficiency that affects about 1 to 2 people in a million.Joenja is expected to launch in the U.S. in early April and will be available for shipment in mid-April, the company said.
APDS causes a lack of functioning immune cells, B cells and T cells, which makes it difficult for people with this disorder to fight off bacterial and viral infections. It also exacerbates the risk of permanent lung damage and lymphoma over time.in 2019, declined to comment on the pricing and said it would provide more details on Monday.
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