The FDA on Tuesday yanked Altus Pharmaceuticals' orphan drug designation for its experimental pancreatic insufficiency therapy, saying the number of patients with the condition exceeds the 200,000 mark required for an orphan drug. The drug--ALTU-135--is intended to treat a rare condition in which a person fails to develop the chemicals and enzymes needed to absorb food. Altus officials say they may consult with the agency about refilling an application.
"We believe that only a subset of patients with HIV/AIDs has fat malabsorbtion due to pancreatic insufficiency and that our original filing was intended to be within the 200,000 person limit for this disease condition, however, the FDA concluded otherwise," Altus said.
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