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New FDA Orphan Drug Designation: Genentech And Idiopathic Pulmonary Fibrosis

March 12, 2015

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

Generic Name: lebrikizumab
Trade Name: n/a
Date Designated: 03-09-2015
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


Please Note: “Chemicals in Flasks by Joe Sullivan (Flickr) [CC-BY-2.0] | Wikimedia Commons.

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