Jul 31 2012
FibroGen, Inc., today announced that FG-3019, the Company's human
monoclonal antibody against connective tissue growth factor (CTGF), has
been granted Orphan Drug Designation by the U.S. Food and Drug
Administration (FDA) for the treatment of idiopathic pulmonary fibrosis
(IPF).
IPF is a progressive and fatal lung disease for which there are no
FDA-approved therapies. FG-3019 was developed to inhibit the activity of
CTGF, a matricellular protein that plays a key role in fibrosis. More
than a decade of research conducted by FibroGen and others has
established the critical role of CTGF as a final common pathway in
chronic fibrotic diseases, in which persistent and excessive scarring
leads to organ dysfunction and failure.
Orphan Drug Designation is generally granted to drugs or biologics
intended for treatment of rare diseases and disorders, i.e., those
affecting fewer than 200,000 people in the U.S. This designation conveys
special incentives to the sponsor, including tax credit for fifty
percent of the cost of clinical trials, prescription drug user fee
waiver, and seven years of U.S. market exclusivity for the drug or
biologic upon FDA approval.
"The granting of FibroGen's request for Orphan Drug Designation
constitutes a major milestone in the development of FG-3019 for
pulmonary fibrosis," said Thomas B. Neff, Chief Executive Officer of
FibroGen. "We have been encouraged by early results from our ongoing
phase 2 studies suggesting that sufficiently high bloodstream levels of
FibroGen's FG-3019 antibody may prevent predicted decline in lung
function and even increase lung capacity in some cases. We are committed
to further clinical evaluation of FG-3019 in hopes of developing a safe
and effective therapy that will provide IPF patients with a superior
treatment outcome."
Source: FibroGen, Inc.