Calliditas Therapeutics announced that the FDA has granted the company two orphan drug designations, one for an autoimmune hepatitis therapy and one for a primary biliary cholangitis therapy, according to recent press releases.
“We are very pleased to receive ODD in the U.S. for the treatment of PBC,” Renée Aguiar-Lucander, CEO of Calliditas Therapeutics, said in a press release. “This confirms the high unmet medical need and further encourages us to continue to explore orphan indications in which we could leverage our existing expertise. This is a disease with few medical alternatives today, but with a lot of exciting research taking place.”
Aguiar-Lucander remarked similarly about the company’s AIH therapy and noted that they are ready to discuss the regulatory pathway with the FDA for each therapy’s indication.
Additionally, researchers at Calliditas are currently running an international phase 3 study for the treatment of IgA nephropathy. The company has received an orphan drug designation for the therapy and expects to announce top-line data in the second half of 2020.