The US Food and Drug Administration on Friday approved Pharming Group's drug to treat a rare genetic disorder that leads to a weakened immune system, the Dutch company said.
- The U.S. Food and Drug Administration on Friday approved Pharming Group's drug to treat a rare genetic disorder that leads to a weakened immune system, the Dutch company said.
The approval comes a month after the European health regulator shifted accelerated review of leniolisib to a standard one, citing the need for the company to submit additional data from an extension study that was conducted post-interim analysis. Pharming, which acquired global rights to Joenja from Novartis in 2019, declined to comment on the pricing and said it would provide more details on Monday.Oppenheimer analyst Hartaj Singh expected Joenja to be priced between $250,000 and $400,000, and forecast peak sales of $200 million to $300 million, ahead of the approval.
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