Amylyx Pharmaceuticals Provides Update on Accès Compassionnel for AMX0035 in France
05 Outubro 2023 - 6:26PM
Business Wire
L’Agence Nationale de Sécurité du Médicament et des produits de
santé (ANSM), the national authority for authorizing medicinal
products in France, has granted “accès compassionnel”
(compassionate access) to AMX0035 (sodium phenylbutyrate and
ursodoxicoltaurine [also known as taurursodiol]) for eligible
people living with amyotrophic lateral sclerosis (ALS) following a
collaborative process involving medical experts, ARSLA and other
ALS advocates, ANSM, and Amylyx. AMX0035 is known as RELYVRIO® in
the United States and ALBRIOZA™ in Canada. For more information,
including eligibility criteria, please visit here.
Separately, the formal re-examination procedure of the Marketing
Authorisation Application of AMX0035 for the treatment of adults
with ALS in the European Union (EU) remains underway. Amylyx
continues to engage with the Committee for Medicinal Products for
Human Use (CHMP) of the European Medicines Agency (EMA) to
prioritize broad and sustainable access to AMX0035 through the
central EU review and approval process.
About RELYVRIO® / ALBRIOZA™ / ALBRIOZA® / AMX0035
RELYVRIO®, an oral, fixed-dose combination of sodium
phenylbutyrate and taurursodiol (known as ursodoxicoltaurine
outside of the U.S.), is approved to treat amyotrophic lateral
sclerosis (ALS) in adults in the U.S. and approved with conditions
as ALBRIOZA™ for the treatment of ALS in Canada. AMX0035 is being
studied for the potential treatment of other neurodegenerative
diseases, and Amylyx is exploring its treatment in other
populations and regions. The formulation of RELYVRIO, ALBRIOZA, and
AMX0035 are identical.
About ALS
ALS is a relentlessly progressive and fatal neurodegenerative
disorder caused by motor neuron death in the brain and spinal cord.
Motor neuron loss in ALS leads to deteriorating muscle function,
the inability to move and speak, respiratory paralysis and
eventually, death. More than 90% of people with ALS have sporadic
disease, showing no clear family history. More than 30,000 people
are estimated to be living with ALS in Europe (European Union and
United Kingdom). People living with ALS have a median survival of
approximately two years from diagnosis.
About Amylyx Pharmaceuticals
Amylyx Pharmaceuticals, Inc. is committed to supporting and
creating more moments for the neurodegenerative disease community
through the discovery and development of innovative new treatments.
Amylyx is headquartered in Cambridge, Massachusetts and has
operations in Canada and EMEA. For more information, visit
amylyx.eu. For investors, please visit investors.amylyx.com.
Forward-Looking Statements
Statements contained in this press release regarding matters
that are not historical facts are “forward-looking statements”
within the meaning of the Private Securities Litigation Reform Act
of 1995, as amended. Because such statements are subject to risks
and uncertainties, actual results may differ materially from those
expressed or implied by such forward-looking statements. Such
statements include, but are not limited to, statements regarding
the timing and results of the global Phase 3 PHOENIX trial; the
potential approval of AMX0035 for the treatment of ALS in countries
other than the United States and Canada; the potential availability
of AMX0035 in countries other than the United States and Canada
through managed access programs; the potential of AMX0035 as a
treatment for ALS and the Company’s plans to explore the use of
AMX0035 for other neurodegenerative diseases; the process and
timing of the EMA’s formal re-examination procedure of the
Company’s Marketing Authorisation Application for AMX0035 for the
treatment of ALS in Europe; and expectations regarding our
longer-term strategy. Any forward-looking statements in this press
release are based on management’s current expectations of future
events and are subject to a number of risks and uncertainties that
could cause actual results to differ materially and adversely from
those set forth in or implied by such forward-looking statements.
Risks that contribute to the uncertain nature of the
forward-looking statements include: Amylyx’ ability to fund
operations, the success, cost, and timing of Amylyx’ program
development activities, Amylyx’ ability to execute on its
commercial and regulatory strategy, regulatory developments,
expectations regarding the outcome of the re-examination of AMX0035
for the treatment of ALS, and Amylyx’ reliance on third parties,
including to conduct clinical trials and manufacture products, and
the effect of global economic uncertainty and financial market
volatility caused by economic effects of rising inflation and
interest rates, the COVID-19 pandemic, geopolitical instability,
changes in international trade relationships and military
conflicts, as well as the risks and uncertainties set forth in
Amylyx’ United States Securities and Exchange Commission (SEC)
filings, including Amylyx’ Quarterly Report on Form 10-Q for the
quarter ended June 30, 2023, and subsequent filings with the SEC.
All forward-looking statements contained in this press release
speak only as of the date on which they were made. Subject to any
obligations under applicable law, Amylyx undertakes no obligation
to update such statements to reflect events that occur or
circumstances that exist after the date on which they were
made.
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version on businesswire.com: https://www.businesswire.com/news/home/20231002634169/en/
Media Amylyx Media Team (857) 799-7274
amylyxmediateam@amylyx.com
Investors Lindsey Allen Amylyx Pharmaceuticals, Inc.
(857) 320-6244 Investors@amylyx.com
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