Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical
company focused on developing and commercializing novel treatments
for gastrointestinal diseases, today announced the placement of
VOQUEZNA® (vonoprazan) tablets for the treatment of adults with
Erosive Esophagitis, commonly referred to as Erosive GERD
(gastroesophageal reflux disease), and relief of heartburn
associated with Erosive Esophagitis on the Express Scripts national
formularies, effective immediately. VOQUEZNA is the first and only
FDA-approved potassium-competitive acid blocker (PCAB) and the
first new class of Erosive GERD treatment to become available in
the United States in over 30 years. Commercial access for VOQUEZNA
tablets is now estimated at 60 million covered lives in the United
States.
“We are thrilled to announce VOQUEZNA has been added to Express
Scripts’ national formularies, highlighting one of the largest
pharmacy benefit management companies in the U.S. is now providing
millions of patients the potential for immediate access to our
novel treatment for Erosive GERD,” said Martin Gilligan, Chief
Commercial Officer of Phathom. “This formulary placement aligns
with our expectations of offering broad access with a single step
through a generic proton pump inhibitor (PPI). Given that most
Erosive GERD patients have already undergone treatment with a PPI,
and many continue to express dissatisfaction with their current
regimens, we are pleased with this outcome. Additionally, we are
actively engaging with the other major PBMs and health plans to
further increase coverage and ensure that patients suffering from
Erosive GERD have widespread access to VOQUEZNA.”
Erosive GERD, also referred to as Erosive Esophagitis, is a
subtype of GERD that affects approximately 20 million people in the
U.S. Research shows high dissatisfaction among patients and
prescribers with current therapies1 and according to medical claims
analysis, approximately 35% of Erosive GERD patients treated with a
prescription PPI switch to a different PPI within three months of
initial treatment.2
Phathom is also offering programs for eligible patients who face
coverage or affordability issues, including co-pay assistance for
patients with commercial insurance. For more information, please
visit www.voquezna.com/savings.
VOQUEZNA is available by prescription only and marketed
exclusively by Phathom Pharmaceuticals. For more information about
VOQUEZNA visit voquezna.com
_______________1 Vaezi MF, Brunton S, Mark
Fendrick A, et al. Patient journey in erosive
oesophagitis: real- world perspectives from US physicians and
patients. BMJ Open Gastro 2022;9:e000941. doi:10.1136/
bmjgast-2022-0009412 AESARA claims
INDICATIONS AND USAGE
VOQUEZNA® (vonoprazan) is a potassium-competitive acid blocker
(PCAB) indicated:
- for the healing of all grades of Erosive Esophagitis (Erosive
Gastroesophageal Reflux Disease or Erosive GERD) and relief of
heartburn associated with Erosive GERD in adults.
- for the maintenance of healing of all grades of Erosive GERD
and relief of heartburn associated with Erosive GERD in
adults.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONSVOQUEZNA is contraindicated in
patients with a known hypersensitivity to vonoprazan or any
component of VOQUEZNA, or in patients receiving
rilpivirine-containing products.
WARNINGS AND PRECAUTIONS
Presence of Gastric Malignancy: In adults,
symptomatic response to therapy with VOQUEZNA does not preclude the
presence of gastric malignancy. Consider additional follow-up and
diagnostic testing in patients who have a suboptimal response or an
early symptomatic relapse after completing treatment with VOQUEZNA.
In older patients, also consider endoscopy.
Acute Tubulointerstitial Nephritis: Acute
tubulointerstitial nephritis (TIN) has been reported with VOQUEZNA.
If suspected, discontinue VOQUEZNA and evaluate patients with
suspected acute TIN.
Clostridioides difficile-Associated
Diarrhea: Published observational studies suggest that
proton pump inhibitors (PPIs) may be associated with an increased
risk of Clostridioides difficile-associated diarrhea (CDAD),
especially in hospitalized patients. VOQUEZNA may also increase the
risk of CDAD. Consider CDAD in patients with diarrhea that does not
improve. Use the shortest duration of VOQUEZNA appropriate to the
condition being treated.
Bone Fracture: Several published observational
studies suggest that PPI therapy may be associated with an
increased risk for osteoporosis-related fractures of the hip,
wrist, or spine, especially in patients receiving high dose
(multiple daily doses) and long-term therapy (a year or longer).
Bone fracture, including osteoporosis-related fracture, has also
been reported with vonoprazan. Use the shortest duration of
VOQUEZNA appropriate to the condition being treated. Patients at
risk for osteoporosis-related fractures should be managed according
to the established treatment guidelines.
Severe Cutaneous Adverse Reactions (SCAR):
Severe cutaneous adverse reactions, including Stevens-Johnson
syndrome (SJS) and toxic epidermal necrolysis (TEN) have been
reported with VOQUEZNA. Discontinue VOQUEZNA at the first signs or
symptoms of SCAR or other signs of hypersensitivity and consider
further evaluation.
Vitamin B12 (Cobalamin) Deficiency: Long-term
use of acid-suppressing drugs can lead to malabsorption of Vitamin
B12 caused by hypo- or achlorhydria. Vitamin B12 deficiency has
been reported postmarketing with vonoprazan. If clinical symptoms
consistent with vitamin B12 deficiency are observed in patients
treated with VOQUEZNA, consider further workup.
Hypomagnesemia and Mineral Metabolism:
Hypomagnesemia has been reported postmarketing with vonoprazan.
Hypomagnesemia may lead to hypocalcemia and/or hypokalemia and may
exacerbate underlying hypocalcemia in at-risk patients.
Consider monitoring magnesium levels prior to initiation of
VOQUEZNA and periodically in patients expected to be on prolonged
treatment, in patients taking drugs that may have increased
toxicity in the presence of hypomagnesemia or drugs that may cause
hypomagnesemia. Treatment of hypomagnesemia may require magnesium
replacement and discontinuation of VOQUEZNA.
Consider monitoring magnesium and calcium levels prior to
initiation of VOQUEZNA and periodically while on treatment in
patients with a preexisting risk of hypocalcemia. Supplement with
magnesium and/or calcium, as necessary. If hypocalcemia is
refractory to treatment, consider discontinuing VOQUEZNA.
Interactions with Diagnostic Investigations for
Neuroendocrine Tumors: Serum chromogranin A (CgA) levels
increase secondary to drug-induced decreases in gastric acidity.
The increased CgA level may cause false positive results in
diagnostic investigations for neuroendocrine tumors. Temporarily
discontinue VOQUEZNA treatment at least 14 days before assessing
CgA levels and consider repeating the test if initial CgA levels
are high.
Fundic Gland Polyps: Use of VOQUEZNA is
associated with a risk of fundic gland polyps that increases with
long-term use, especially beyond one year. Fundic gland polyps have
been reported with vonoprazan in clinical trials and during
postmarketing use with PPIs. Most patients who developed fundic
gland polyps were asymptomatic and fundic gland polyps were
identified incidentally on endoscopy. Use the shortest duration of
VOQUEZNA appropriate to the condition being treated.
ADVERSE REACTIONS:
Healing of Erosive GERD: The most common
adverse reactions (≥2% of patients in the VOQUEZNA arm) include
gastritis (3%), diarrhea (2%), abdominal distention (2%), abdominal
pain (2%), and nausea (2%).
Maintenance of Healed Erosive GERD: The most
common adverse reactions (≥3% of patients in the VOQUEZNA arm)
include gastritis (6%), abdominal pain (4%), dyspepsia (4%),
hypertension (3%), and urinary tract infection (3%).
DRUG INTERACTIONSVOQUEZNA has the potential for
clinically important drug interactions, including interactions with
drugs dependent on gastric pH for absorption, drugs that are
substrates for certain CYP enzymes, and some diagnostic tests.
Avoid concomitant use of VOQUEZNA with atazanavir or nelfinavir.
See full Prescribing Information for more details about important
drug interactions. Consult the labeling of concomitantly used drugs
to obtain further information about interactions with
vonoprazan.
USE IN SPECIFIC POPULATIONS
Lactation: Breastfeeding is not recommended
during treatment. Because of the potential risk of adverse liver
effects shown in animal studies with vonoprazan, advise patients
not to breastfeed during treatment with VOQUEZNA.
Renal Impairment: For the healing of Erosive
GERD, dosage reduction is recommended in patients with severe renal
impairment (eGFR < 30 mL/min). Hepatic
Impairment: For the healing of Erosive GERD, dosage
reduction is recommended in patients with moderate to severe
hepatic impairment (Child-Pugh Class B and C).
You are encouraged to report suspected adverse reactions
by contacting Phathom Pharmaceuticals at 1-888-775-PHAT (7428) or
FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.
Please see full Prescribing
Information for VOQUEZNA.
About VOQUEZNA®VOQUEZNA® (vonoprazan) tablets
contain vonoprazan, an oral small
molecule potassium-competitive acid blocker (PCAB), approved
in the U.S. for the treatment of adults with Erosive Esophagitis,
also known as Erosive GERD, and the relief of heartburn associated
with Erosive GERD. PCABs are a novel class of medicines that block
acid secretion in the stomach. Vonoprazan is the first gastric
anti-secretory agent from a novel class approved in the United
States in over 30 years, and has shown rapid, potent, and durable
anti-secretory effects. PCABs are a novel class of medicines that
block acid secretion in the stomach. Phathom in-licensed the U.S.
rights to vonoprazan from Takeda, which markets the product in
Japan and numerous other countries in Asia and Latin
America.
About Phathom Pharmaceuticals,
Inc. Phathom Pharmaceuticals is a biopharmaceutical
company focused on the development and commercialization of novel
treatments for gastrointestinal diseases. Phathom has in-licensed
the exclusive rights in the United States, Europe, and Canada to
vonoprazan, a first-in-class potassium-competitive acid blocker
(PCAB). For more information about Phathom, visit the Company’s
website at www.phathompharma.com and follow the Company on
LinkedIn and X.
Forward-Looking Statements Phathom cautions you
that statements contained in this press release regarding matters
that are not historical facts are forward-looking statements. These
statements are based on the Company’s current beliefs and
expectations. Such forward-looking statements include, but are not
limited to, statements regarding patient access and continued
expansion in commercial coverage with other payers. The inclusion
of forward-looking statements should not be regarded as a
representation by Phathom that any of its plans will be achieved.
Actual results may differ from those set forth in this press
release due to the risks and uncertainties inherent in Phathom’s
business, including, without limitation: we may not be able to
successfully commercialize VOQUEZNA which will depend on a number
of factors including coverage and reimbursement levels from
governmental authorities and health insurers as well as market
acceptance by healthcare providers; the inherent risks of clinical
development of vonoprazan; Phathom’s dependence on third parties in
connection with product manufacturing, research and preclinical and
clinical testing; regulatory developments in the United States and
foreign countries; unexpected adverse side effects or inadequate
efficacy of vonoprazan that may limit its development, regulatory
approval and/or commercialization, or may result in recalls or
product liability claims; Phathom’s ability to access additional
capital under its term loan facility and royalty interest finance
agreements is subject to certain conditions; Phathom’s ability to
obtain and maintain intellectual property protection for
vonoprazan; Phathom’s ability to comply with its license agreement
with Takeda; and other risks described in the Company’s prior press
releases and the Company’s filings with the Securities and Exchange
Commission (SEC), including under the heading “Risk Factors” in the
Company’s Annual Report on Form 10-K and any subsequent filings
with the SEC. You are cautioned not to place undue reliance on
these forward-looking statements, which speak only as of the date
hereof, and Phathom undertakes no obligation to update such
statements to reflect events that occur or circumstances that exist
after the date hereof. All forward-looking statements are qualified
in their entirety by this cautionary statement, which is made under
the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995.
MEDIA CONTACTNick
Benedetto1-877-742-8466media@phathompharma.com
INVESTOR CONTACTEric
Sciorilli1-877-742-8466ir@phathompharma.com
© 2024 Phathom Pharmaceuticals. All rights reserved.
VOQUEZNA, Phathom Pharmaceuticals, and their respective logos
are registered trademarks or trademarks of Phathom Pharmaceuticals,
Inc.
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