Investigational SGLT2 Inhibitor Submitted as
Monotherapy and in Fixed-Dose Combinations with JANUVIA®
(sitagliptin) or Metformin
Merck (NYSE:MRK), known as MSD outside the United States and
Canada, and Pfizer Inc. (NYSE:FE), today announced that the U.S.
Food and Drug Administration (FDA) has accepted for review three
New Drug Applications (NDAs) for medicines containing
ertugliflozin, an investigational SGLT2 inhibitor in development to
help improve glycemic control in adults with type 2 diabetes: one
for monotherapy, one for the fixed-dose combination of
ertugliflozin and JANUVIA® (sitagliptin), and one for the
fixed-dose combination of ertugliflozin and metformin. The
Prescription Drug User Fee Act (PDUFA) action date from the FDA is
in December 2017 for the three NDAs. Additionally, the European
Medicines Agency (EMA) has validated for review three Marketing
Authorization Applications (MAAs) for ertugliflozin monotherapy and
the two fixed-dose combination products.
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These marketing applications to the FDA and EMA are supported by
studies in the VERTIS clinical development program of
ertugliflozin, including VERTIS MONO, VERTIS FACTORIAL, and VERTIS
SITA2, which were first presented at medical congresses in 2016.
The full VERTIS clinical development program is comprised of nine
Phase 3 trials in approximately 12,600 adults with type 2
diabetes.
“The acceptance of the three applications by both the FDA and
EMA represents an important milestone in the progression of our
collaboration with Pfizer on ertugliflozin, and reflects Merck’s
commitment to advancing new treatment options for people with type
2 diabetes around the world,” said Sam Engel, M.D., associate vice
president, Merck clinical research, diabetes and endocrinology. “If
approved, we believe ertugliflozin will be an important option for
many patients and a welcome addition to our already strong type 2
diabetes portfolio, with our DPP-4 inhibitor JANUVIA as the
foundation.”
“Because type 2 diabetes is a progressive disease, patients may
need multiple treatment options to help them manage their
condition. That is why we are proud of the comprehensive VERTIS
clinical development program, and we look forward to working
closely with the FDA and EMA in an effort to bring these three
additional treatment options to adults with type 2 diabetes,” said
James Rusnak, M.D., Ph.D., chief development officer,
cardiovascular and metabolic diseases, Pfizer Global Product
Development.
Important Information about JANUVIA®
(sitagliptin) 25 mg, 50 mg and 100 mg tablets
JANUVIA is indicated as an adjunct to diet and exercise to
improve glycemic control in adults with type 2 diabetes mellitus.
JANUVIA should not be used in patients with type 1 diabetes or for
the treatment of diabetic ketoacidosis. JANUVIA has not been
studied in patients with a history of pancreatitis. It is unknown
whether patients with a history of pancreatitis are at increased
risk of developing pancreatitis while taking JANUVIA.
Selected Important Risk Information about
JANUVIA®
JANUVIA is contraindicated in patients with a history of a
serious hypersensitivity reaction to sitagliptin, such as
anaphylaxis or angioedema.
There have been postmarketing reports of acute pancreatitis,
including fatal and nonfatal hemorrhagic or necrotizing
pancreatitis, in patients taking JANUVIA. After initiating JANUVIA,
observe patients carefully for signs and symptoms of pancreatitis.
If pancreatitis is suspected, promptly discontinue JANUVIA and
initiate appropriate management. It is unknown whether patients
with a history of pancreatitis are at increased risk of developing
pancreatitis while taking JANUVIA.
Assessment of renal function is recommended prior to initiating
JANUVIA and periodically thereafter. A dosage adjustment is
recommended in patients with moderate or severe renal insufficiency
and in patients with end-stage renal disease requiring hemodialysis
or peritoneal dialysis. Caution should be used to ensure that the
correct dose of JANUVIA is prescribed.
There have been postmarketing reports of worsening renal
function, including acute renal failure, sometimes requiring
dialysis. A subset of these reports involved patients with renal
insufficiency, some of whom were prescribed inappropriate doses of
sitagliptin.
When JANUVIA was used in combination with a sulfonylurea or
insulin, medications known to cause hypoglycemia, the incidence of
hypoglycemia was increased over that of placebo. Therefore, a lower
dose of sulfonylurea or insulin may be required to reduce the risk
of hypoglycemia.
The incidence (and rate) of hypoglycemia based on all reports of
symptomatic hypoglycemia were: 12.2% (0.59 episodes/patient-year)
for JANUVIA 100 mg in combination with glimepiride (with or without
metformin), 1.8% (0.24 episodes/patient-year) for placebo in
combination with glimepiride (with or without metformin), 15.5%
(1.06 episodes/patient-year) for JANUVIA 100 mg in combination with
insulin (with or without metformin), and 7.8% (0.51
episodes/patient-year) for placebo in combination with insulin
(with or without metformin).
There have been postmarketing reports of serious
hypersensitivity reactions in patients treated with JANUVIA, such
as anaphylaxis, angioedema, and exfoliative skin conditions
including Stevens –Johnson syndrome. Onset of these reactions
occurred within the first 3 months after initiation of treatment
with JANUVIA, with some reports occurring after the first dose. If
a hypersensitivity reaction is suspected, discontinue JANUVIA,
assess for other potential causes for the event, and institute
alternative treatment for diabetes.
Angioedema has also been reported with other dipeptidyl
peptidase-4 (DPP-4) inhibitors. Use caution in a patient with a
history of angioedema with another DPP-4 inhibitor because it is
unknown whether such patients will be predisposed to angioedema
with JANUVIA.
There have been postmarketing reports of severe and disabling
arthralgia in patients taking DPP-4 inhibitors. The time to onset
of symptoms following initiation of drug therapy varied from 1 day
to years. Patients experienced relief of symptoms upon
discontinuation of the medication. A subset of patients experienced
a recurrence of symptoms when restarting the same drug or a
different DPP-4 inhibitor. Consider DPP-4 inhibitors as a possible
cause for severe joint pain and discontinue drug if
appropriate.
Postmarketing cases of bullous pemphigoid requiring
hospitalization have been reported with DPP-4 inhibitor use. In
reported cases, patients typically recovered with topical or
systemic immunosuppressive treatment and discontinuation of the
DPP-4 inhibitor. Tell patients to report development of blisters or
erosions while receiving JANUVIA. If bullous pemphigoid is
suspected, JANUVIA should be discontinued and referral to a
dermatologist should be considered for diagnosis and appropriate
treatment.
There have been no clinical studies establishing conclusive
evidence of macrovascular risk reduction with JANUVIA or with any
other antidiabetic drug.
In clinical studies, the adverse reactions reported, regardless
of investigator assessment of causality, in ≥5% of patients treated
with JANUVIA as monotherapy and in combination therapy and more
commonly than in patients treated with placebo, were upper
respiratory tract infection, nasopharyngitis, and headache.
About Merck
For over a century, Merck has been a global health care leader
working to help the world be well. Merck is known as MSD outside
the United States and Canada. Through our prescription medicines,
vaccines, biologic therapies, and animal health products, we work
with customers and operate in more than 140 countries to deliver
innovative health solutions. We also demonstrate our commitment to
increasing access to health care through far-reaching policies,
programs and partnerships. For more information, visit
www.merck.com and connect with us on Twitter, Facebook, YouTube and
LinkedIn.
About Pfizer Inc.: Working together for a healthier
world®
At Pfizer, we apply science and our global resources to bring
therapies to people that extend and significantly improve their
lives. We strive to set the standard for quality, safety and value
in the discovery, development and manufacture of health care
products. Our global portfolio includes medicines and vaccines as
well as many of the world's best-known consumer health care
products. Every day, Pfizer colleagues work across developed and
emerging markets to advance wellness, prevention, treatments and
cures that challenge the most feared diseases of our time.
Consistent with our responsibility as one of the world's premier
innovative biopharmaceutical companies, we collaborate with health
care providers, governments and local communities to support and
expand access to reliable, affordable health care around the world.
For more than 150 years, we have worked to make a difference for
all who rely on us. We routinely post information that may be
important to investors on our website at www.pfizer.com. In
addition, to learn more, please visit us on www.pfizer.com and
follow us on Twitter at @Pfizer and @PfizerNews, LinkedIn, YouTube
and like us on Facebook at Facebook.com/Pfizer.
Forward-Looking Statement of Merck & Co., Inc.,
Kenilworth, N.J., USA
This news release of Merck & Co., Inc., Kenilworth, N.J.,
USA (the “company”) includes “forward-looking statements” within
the meaning of the safe harbor provisions of the U.S. Private
Securities Litigation Reform Act of 1995. These statements are
based upon the current beliefs and expectations of the company’s
management and are subject to significant risks and uncertainties.
There can be no guarantees with respect to pipeline products that
the products will receive the necessary regulatory approvals or
that they will prove to be commercially successful. If underlying
assumptions prove inaccurate or risks or uncertainties materialize,
actual results may differ materially from those set forth in the
forward-looking statements.
Risks and uncertainties include but are not limited to, general
industry conditions and competition; general economic factors,
including interest rate and currency exchange rate fluctuations;
the impact of pharmaceutical industry regulation and health care
legislation in the United States and internationally; global trends
toward health care cost containment; technological advances, new
products and patents attained by competitors; challenges inherent
in new product development, including obtaining regulatory
approval; the company’s ability to accurately predict future market
conditions; manufacturing difficulties or delays; financial
instability of international economies and sovereign risk;
dependence on the effectiveness of the company’s patents and other
protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory
actions.
The company undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise. Additional factors that could cause
results to differ materially from those described in the
forward-looking statements can be found in the company’s 2016
Annual Report on Form 10-K and the company’s other filings with the
Securities and Exchange Commission (SEC) available at the SEC’s
Internet site (www.sec.gov).
Pfizer Disclosure Notice
The information contained in this release is as of March 6,
2017. Pfizer assumes no obligation to update forward-looking
statements contained in this release as the result of new
information or future events or developments.
This release contains forward-looking information about a
product candidate, ertugliflozin, and applications submitted to the
FDA and the EMA for monotherapy and fixed-dose combinations,
including their potential benefits, that involves substantial risks
and uncertainties that could cause actual results to differ
materially from those expressed or implied by such statements.
Risks and uncertainties include, among other things, the
uncertainties inherent in research and development, including the
ability to meet anticipated trial commencement and completion dates
and regulatory submission dates, as well as the possibility of
unfavorable clinical trial results, including unfavorable new
clinical data and additional analyses of existing clinical data;
whether and when any applications for ertugliflozin may be filed
with regulatory authorities in any other jurisdictions; whether and
when the FDA and EMA may approve the pending applications and
whether and when regulatory authorities in any other jurisdictions
may approve any such other applications, which will depend on the
assessment by such regulatory authorities of the benefit-risk
profile suggested by the totality of the efficacy and safety
information submitted; decisions by regulatory authorities
regarding labeling and other matters that could affect the
availability or commercial potential of ertugliflozin in
monotherapy or in fixed-dose combination; and competitive
developments. The competitive landscape for type 2 diabetes
therapies, including SGLT2 inhibitors, continues to evolve. The
success of our ertugliflozin program is dependent on developments
in that space.
A further description of risks and uncertainties can be found in
Pfizer’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2016 and in its subsequent reports on Form 10-Q,
including in the sections thereof captioned “Risk Factors” and
“Forward-Looking Information and Factors That May Affect Future
Results”, as well as in its subsequent reports on Form 8-K, all of
which are filed with the U.S. Securities and Exchange Commission
and available at www.sec.gov and www.pfizer.com.
Please see Prescribing Information for JANUVIA®
(sitagliptin) at
http://www.merck.com/product/usa/pi_circulars/j/januvia/januvia_pi.pdf
and Medication Guide for JANUVIA at
http://www.merck.com/product/usa/pi_circulars/j/januvia/januvia_mg.pdf
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version on businesswire.com: http://www.businesswire.com/news/home/20170306005393/en/
Merck Media:Doris Li, (908) 246-5701orMerck Investor:Amy Klug,
(908) 740-1898orKristen Drake, (908) 236-4223orPfizer Media:Steve
Danehy, (212) 733-1538orPfizer Investor:Ryan Crowe, (212)
733-8160
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