Anthera Announces FDA Orphan Drug Designation for Blisibimod for the Treatment of IgA Nephropathy
August 09 2017 - 4:00PM
Anthera Pharmaceuticals (Nasdaq:ANTH) today announced that
blisibimod has received orphan drug designation from the U.S. Food
and Drug Administration (FDA) for the treatment of Immunoglobulin A
nephropathy (IgAN). Blisibimod targets B-cell activating
factor, or BAFF, which has been shown to be elevated in a variety
of B-cell mediated autoimmune diseases, including IgAN, systemic
lupus erythematosus, and others.
“We are pleased by the FDA’s decision to designate blisibimod
with orphan drug designation,” said Craig Thompson, Chief Executive
Officer of Anthera. “There remains a very high need for patients
with IgA nephropathy, as no approved therapies currently exist
despite the high proportion of patients who progress to end-stage
renal disease. We remain optimistic that blisibimod may be a
well-tolerated, disease-modifying therapeutic that targets the
underlying pathology for IgAN.”
Anthera is currently analyzing the data from the randomized,
double-blind, placebo controlled, Phase 2 BRIGHT-SC study of
blisibimod in patients with IgA nephropathy (IgAN). After Week 24,
patients were given the opportunity to continue blinded treatment
for up to 104 weeks, discontinue treatment but continue to be
followed, or discontinue from the study. Most patients, 42 of 57,
completed at least 60 weeks of evaluation and 21 completed
assessments through at least 104 weeks. Anthera anticipates
reporting top-line data later this month.
IgAN, also known as Berger’s disease is the most common cause of
primary glomerulonephritis (acute inflammation of the kidney)
worldwide, occurring more frequently in Asia than in Europe or
North America. IgAN is characterized by deposition of immune
complexes in the kidney, resulting in inflammation, the leakage of
blood and protein into the urine, and loss of kidney function. The
disease typically progresses slowly but as many as 40-50% of adults
will eventually develop end-stage-renal disease and require
dialysis or kidney transplant. There are currently no
approved therapies for IgA nephropathy.
The Orphan Drug Designation program provides orphan
status to drugs and biologics which are defined as those intended
for the safe and effective treatment, diagnosis or prevention of
rare diseases/disorders that affect fewer than 200,000 people in
the U.S. annually. Orphan designation qualifies the sponsor of the
drug for various development incentives, including tax credits for
qualified clinical testing.
About Anthera Pharmaceuticals
Anthera Pharmaceuticals is a clinical-stage biopharmaceutical
company focused on developing products to treat serious and
life-threatening diseases, including exocrine pancreatic
insufficiency and IgA nephropathy. Additional information on the
Company can be found at www.anthera.com.
Safe Harbor Statement
Any statements contained in this press release that refer to
future events or other non-historical matters, including statements
that are preceded by, followed by, or that include such words as
"estimate," "intend," "anticipate," "believe," "plan," "goal,"
"expect," "project," or similar statements, are forward-looking
statements made pursuant to the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995. Such
statements are based on Anthera's expectations as of the date
of this press release and are subject to certain risks and
uncertainties that could cause actual results to differ materially,
including but not limited to those set forth in Anthera's public
filings with the SEC, including Anthera's Quarterly Report on
Form 10-Q for the quarter ended June 30, 2017. Anthera
disclaims any intent or obligation to update any forward-looking
statements, whether because of new information, future events or
otherwise, except as required by applicable law.
CONTACT: Investor Relations of Anthera Pharmaceuticals,
Inc.ir@anthera.com
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frannie.marmorstein@rbbcommunications.com 305-567-0821
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