FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

FDA Grants Orphan Designation to Samumed’s IPF Treatment

Aug. 1, 2017
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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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