Vertex Announces FDA Acceptance of New Drug Application for Suzetrigine for the Treatment of Moderate-to-Severe Acute Pain
30 Luglio 2024 - 7:10PM
Business Wire
– FDA grants priority review and assigns a
Prescription Drug User Fee Act (PDUFA) target action date of
January 30, 2025 –
– Suzetrigine, an investigational non-opioid
pain signal inhibitor, has the potential to treat millions of
patients who suffer from moderate-to-severe acute pain each year
–
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today
announced that the U.S. Food and Drug Administration (FDA) has
accepted its New Drug Application (NDA) submission for suzetrigine,
an investigational, oral, selective NaV1.8 pain signal inhibitor to
treat moderate-to-severe acute pain. Suzetrigine has the potential
to be the first new class of medicine to treat acute pain in over
twenty years.
The FDA has granted suzetrigine priority review and assigned a
Prescription Drug User Fee Act (PDUFA) target action date of
January 30, 2025. Suzetrigine has already been granted FDA Fast
Track and Breakthrough Therapy designations for the treatment of
moderate-to-severe acute pain.
“Today’s FDA filing acceptance for suzetrigine marks a critical
milestone toward bringing this new, transformative non-opioid
analgesic to the millions of patients suffering from
moderate-to-severe acute pain each year in the U.S.,” said Nia
Tatsis, Ph.D., Executive Vice President, Chief Regulatory and
Quality Officer at Vertex. “The FDA’s granting of a priority review
further reinforces the high unmet need in treating acute pain, and
the filing brings us one step closer to our objective of filling
the gap between medicines with good tolerability but limited
efficacy and opioid medicines with therapeutic efficacy but known
risks, including addictive potential.”
"In my 24 years practicing medicine, I have seen firsthand the
desperate need for new non-opioid therapies for treating pain. Too
many people today are either undertreated, dealing with negative
side effects of currently available therapies or foregoing pain
medications altogether for fear of becoming dependent on opioids,”
said Scott Weiner, M.D., M.P.H., Vertex Acute Pain Steering
Committee Chair, Associate Professor of Emergency Medicine at
Harvard Medical School and Attending Emergency Physician in the
Department of Emergency Medicine at Brigham and Women’s Hospital.
“Prescribers and patients deserve new options."
About Acute Pain
Acute pain is a disabling condition and is defined as pain
lasting less than 3 months. It is estimated that over 80 million
people are prescribed a medicine for acute pain every year in the
U.S. Due to limited treatment options, there is an unmet need in
acute pain management to improve the patient experience and reduce
the economic and societal burden.
About Suzetrigine (VX-548)
Suzetrigine (formerly VX-548) is an investigational oral,
selective NaV1.8 pain signal inhibitor that is highly selective for
NaV1.8 relative to other NaV channels. NaV1.8 is a voltage-gated
sodium channel that is selectively expressed in peripheral
pain-sensing neurons (nociceptors), where its role is to transmit
pain signals (action potentials). NaV1.8 is a genetically validated
target for the treatment of pain, and suzetrigine has demonstrated
a favorable benefit/risk profile in three Phase 3 studies and two
Phase 2 studies in patients with moderate-to-severe acute pain.
Suzetrigine also demonstrated positive results and a well-tolerated
profile in a Phase 2 study in patients with pain associated with
diabetic peripheral neuropathy, a type of chronic peripheral
neuropathic pain. Vertex’s approach is to selectively inhibit
NaV1.8 using small molecules with the objective of creating a new
class of pain signal inhibitors that have the potential to provide
effective relief of pain without the limitations of currently
available therapies, including the addictive potential of
opioids.
About Vertex
Vertex is a global biotechnology company that invests in
scientific innovation to create transformative medicines for people
with serious diseases. The company has approved medicines that
treat the underlying causes of multiple chronic, life-shortening
genetic diseases — cystic fibrosis, sickle cell disease and
transfusion-dependent beta thalassemia — and continues to advance
clinical and research programs in these diseases. Vertex also has a
robust clinical pipeline of investigational therapies across a
range of modalities in other serious diseases where it has deep
insight into causal human biology, including acute and neuropathic
pain, APOL1-mediated kidney disease, IgA nephropathy, autosomal
dominant polycystic kidney disease, type 1 diabetes, myotonic
dystrophy type 1 and alpha-1 antitrypsin deficiency.
Vertex was founded in 1989 and has its global headquarters in
Boston, with international headquarters in London. Additionally,
the company has research and development sites and commercial
offices in North America, Europe, Australia, Latin America and the
Middle East. Vertex is consistently recognized as one of the
industry's top places to work, including 14 consecutive years on
Science magazine's Top Employers list and one of Fortune’s 100 Best
Companies to Work For. For company updates and to learn more about
Vertex's history of innovation, visit www.vrtx.com or follow us on
LinkedIn, Facebook, Instagram, YouTube and Twitter/X.
Special Note Regarding Forward-Looking Statements
This press release contains forward-looking statements as
defined in the Private Securities Litigation Reform Act of 1995, as
amended, including, without limitation, the statements by Nia
Tatsis, Ph.D., and Scott Weiner, M.D., M.P.H., in this press
release, and statements regarding our expectations for the benefits
of and potential for suzetrigine as a treatment for
moderate-to-severe acute pain. While we believe the forward-looking
statements contained in this press release are accurate, these
forward-looking statements represent the company's beliefs only as
of the date of this press release and there are a number of risks
and uncertainties that could cause actual events or results to
differ materially from those expressed or implied by such
forward-looking statements. Those risks and uncertainties include,
among other things, that data from the company's development
programs may not support registration or further development of its
compounds due to safety, efficacy, and other reasons, that future
competitive or other market factors may adversely affect the
commercial potential for suzetrigine, and other risks listed under
the heading “Risk Factors” in Vertex's most recent annual report
and subsequent quarterly reports filed with the Securities and
Exchange Commission at www.sec.gov and available through the
company's website at www.vrtx.com. You should not place undue
reliance on these statements. Vertex disclaims any obligation to
update the information contained in this press release as new
information becomes available.
(VRTX-GEN)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240730731594/en/
Vertex Pharmaceuticals Incorporated Investors:
InvestorInfo@vrtx.com Susie Lisa, CFA: +1 617-341-6108 or Miroslava
Minkova: +1 617-341-6135
Media: mediainfo@vrtx.com or International: +44 20 3204
5275 or U.S.: 617-341-6992 or Heather Nichols: +1 617-839-3607
Grafico Azioni Vertex Pharmaceuticals (NASDAQ:VRTX)
Storico
Da Dic 2024 a Gen 2025
Grafico Azioni Vertex Pharmaceuticals (NASDAQ:VRTX)
Storico
Da Gen 2024 a Gen 2025
