Sanofi: FDA lifts clinical hold on fitusiran
15 Dezembro 2017 - 10:00AM
Press
Release
Source: Sanofi (EURONEXT: SAN) (NYSE: SNY)
FDA lifts clinical hold on
fitusiran
Paris and
Cambridge, Mass. - December 15, 2017 - Sanofi Genzyme, the
specialty care global business unit of Sanofi, and Alnylam
Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics
company, announced today that the U.S. Food and Drug Administration
(FDA) has lifted the hold on clinical studies with fitusiran,
including the Phase 2 open-label extension (OLE) study and the
ATLAS Phase 3 program.
Alnylam and the FDA had previously
reached alignment on new clinical risk mitigation measures,
including protocol-specified guidelines and additional investigator
and patient education concerning reduced doses of replacement
factor or bypassing agent to treat any breakthrough bleeds in
fitusiran studies.
The FDA has now approved the
protocol amendments and other updated clinical materials for
fitusiran studies. Fitusiran is an investigational RNAi therapeutic
targeting antithrombin (AT) for the treatment of patients with
hemophilia A and B. It is designed to lower levels of AT with the
goal of promoting sufficient thrombin generation to restore
hemostasis and prevent bleeding.
"We are pleased with the FDA's decision to
lift the clinical hold, as fitusiran holds the potential to help
improve the lives of people living with hemophilia," said Akin
Akinc, Ph.D., Vice President and General Manager, Fitusiran at
Alnylam. "With the additional risk mitigation measures in place, we
look forward to the continued late-stage development of fitusiran
and expect to resume dosing around year-end."
The clinical significance of the
fitusiran mechanism of action is under investigation. Fitusiran has
not been approved by the FDA, EMA or any other regulatory authority
for any indication and no conclusions can or should be drawn
regarding the safety or effectiveness of this investigational
therapeutic.
Sanofi has an alliance with
Alnylam Pharmaceuticals to co-develop and co-commercialize
fitusiran in the United States, Canada and Western Europe. In
addition, Sanofi has the exclusive right to commercialize fitusiran
in the rest of the world.
About Sanofi
Sanofi is dedicated to supporting people through their health
challenges. We are a global biopharmaceutical company focused on
human health. We prevent illness with vaccines, provide innovative
treatments to fight pain and ease suffering. We stand by the few
who suffer from rare diseases and the millions with long-term
chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is
transforming scientific innovation into healthcare solutions around
the globe.
Sanofi Genzyme focuses on developing specialty treatments for
debilitating diseases that are often difficult to diagnose and
treat, providing hope to patients and their families. Learn more at
www.sanofigenzyme.com.
Sanofi, Empowering Life
About Alnylam Pharmaceuticals
Alnylam (Nasdaq: ALNY) is leading the
translation of RNA interference (RNAi) into a whole new class of
innovative medicines with the potential to transform the lives of
people afflicted with rare genetic, cardio-metabolic, and hepatic
infectious diseases. Based on Nobel Prize-winning science, RNAi
therapeutics represent a powerful, clinically validated approach
for the treatment of a wide range of severe and debilitating
diseases. Founded in 2002, Alnylam is delivering on a bold vision
to turn scientific possibility into reality, with a robust
discovery platform and deep pipeline of investigational medicines,
including four product candidates that are in late-stage
development. Looking forward, Alnylam will continue to execute on
its "Alnylam 2020" strategy of building a multi-product,
commercial-stage biopharmaceutical company with a sustainable
pipeline of RNAi-based medicines to address the needs of patients
who have limited or inadequate treatment options. Alnylam employs
over 600 people in the U.S. and Europe and is headquartered in
Cambridge, MA. For more information about our people, science and
pipeline, please visit www.alnylam.com and engage with us on
Twitter at @Alnylam or on LinkedIn.
|
Sanofi Contacts
Media Relations Ashleigh Koss
Tel. : +1 (908) 981-8745
Mobile: +1 (908) 205-2572
mr@sanofi.com
Alnylam
Contacts
Investor and Media Relations Christine Regan
Lindenboom
Tel: +1 (617) 682-4340
|
Investor
Relations George Grofik
Tel.: +33 (0)1 53 77 45 45
ir@sanofi.com
Investor
Relations Josh Brodsky
Tel: +1 (617) 551-8276
|
Sanofi
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Forward-Looking Statements" in Sanofi's annual report on Form 20-F
for the year ended December 31, 2016. Other than as required by
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Alnylam Forward Looking
Statements Various statements in this release concerning Alnylam's
future expectations, plans and prospects, including without
limitation, Alnylam's views with respect to the potential for
fitusiran for the treatment of people with hemophilia, expectations
regarding the timing for resumption of dosing in the fitusiran
Phase 2 OLE study and Phase 3 ATLAS program, and expectations
regarding its "Alnylam 2020" guidance for the advancement and
commercialization of RNAi therapeutics, constitute forward-looking
statements for the purposes of the safe harbor provisions under The
Private Securities Litigation Reform Act of 1995. Actual results
and future plans may differ materially from those indicated by
these forward-looking statements as a result of various important
risks, uncertainties and other factors, including, without
limitation, Alnylam's ability to discover and develop novel drug
candidates and delivery approaches, successfully demonstrate the
efficacy and safety of its product candidates, the pre-clinical and
clinical results for its product candidates, which may not be
replicated or continue to occur in other subjects or in additional
studies or otherwise support further development of product
candidates for a specified indication or at all, actions or advice
of regulatory agencies, which may affect the design, initiation,
timing, continuation and/or progress of clinical trials or result
in the need for additional pre-clinical and/or clinical testing,
delays, interruptions or failures in the manufacture and supply of
its product candidates, obtaining, maintaining and protecting
intellectual property, Alnylam's ability to enforce its
intellectual property rights against third parties and defend its
patent portfolio against challenges from third parties, obtaining
and maintaining regulatory approval, pricing and reimbursement for
products, progress in establishing a commercial and ex-United
States infrastructure, competition from others using
technology similar to Alnylam's and others developing products for
similar uses, Alnylam's ability to manage its growth and operating
expenses, obtain additional funding to support its business
activities, and establish and maintain strategic business alliances
and new business initiatives, Alnylam's dependence on third parties
for development, manufacture and distribution of products, the
outcome of litigation, the risk of government investigations, and
unexpected expenditures, as well as those risks more fully
discussed in the "Risk Factors" filed with Alnylam's most recent
Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission(SEC) and in other filings that Alnylam makes
with the SEC. In addition, any forward-looking statements
represent Alnylam's views only as of today, and should not be
relied upon as representing its views as of any subsequent date.
Alnylam explicitly disclaims any obligation, except to the extent
required by law, to update any forward-looking
statements.
|
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Source: Sanofi via Globenewswire
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