New FDA Orphan Drug Designation: Genentech And Idiopathic Pulmonary Fibrosis
On March 9th, Genentech receives a FDA Orphan Drug Designation (ODD) for Lebrikizumab for the treatment of the rare disease, Idiopathic Pulmonary Fibrosis (IPF). Lebrikizumab is a novel humanized monoclonal antibody designed to specifically block the action of the interleukin-13 cytokine, and so reduce airway inflammation. A Phase II clinical trial for Lebrikizumab in patients with IPF is currently recruiting participants.
IPF is a chronic, progressive, severely debilitating and ultimately fatal lung disease – characterized by progressive permanent scarring of lung tissue. There are approximately 100,000 Americans with IPF. In October 2014, the FDA approves two Breakthrough Therapy Designations (BTDs) for IPF:
• InterMune’s Esbriet (Pirfenidone)
• Boehringer Ingelheim Pharmaceuticals’ Ofev (Nintedanib).
FDA ODD Database Record For Genentech
|Orphan Designation:||Idiopathic pulmonary fibrosis|
|Orphan Designation Status:||Designated|
|FDA Orphan Approval Status:||Not FDA Approved for Orphan Indication|
|Sponsor:||Genentech, Inc. 1 DNA Way South San Francisco, CA 94080-4990|
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