Home » FDA Grants Orphan Designation to Samumed’s IPF Treatment
FDA Grants Orphan Designation to Samumed’s IPF Treatment
The FDA granted Samumed an Orphan Drug designation for its SM04646 compound for idiopathic pulmonary fibrosis, a chronic disorder that causes deteriorating lung function.
The drug is administered locally via a nebulizer and has the potential to be used as a monotherapy or in combination with currently approved oral medications, Esbriet (pirfenidone) or Ofev (nintedanib).
Samumed recently completed a Phase I study in healthy subjects, with SM04646 appearing to be safe and well tolerated.
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