FDA Advisory Committee Recommends Approval of Canagliflozin for Treatment of Adults with Type 2 Diabetes

 FDA Advisory Committee Recommends Approval of Canagliflozin for Treatment of
                         Adults with Type 2 Diabetes

PR Newswire

RARITAN, N.J., Jan. 10, 2013

RARITAN, N.J., Jan.10, 2013 /PRNewswire/ --Janssen Research & Development,
LLC (Janssen) announced today that the Endocrinologic and Metabolic Drugs
Advisory Committee of the U.S. Food and Drug Administration (FDA) voted 10-5
to recommend approval for canagliflozin, proposed trade name INVOKANA™, to
treat type 2 diabetes in adult patients based on the efficacy and safety
results from its comprehensive clinical development program.

Canagliflozin is an investigational, oral, once-daily medication for the
treatment of adult patients with type 2 diabetes. If approved by the FDA later
this year, it would be the first in this new class of diabetes therapies
available in the U.S. The kidneys of people with type 2 diabetes reabsorb
greater amounts of glucose back into the body compared to people who do not
have diabetes, which may contribute to elevated glucose levels. Canagliflozin,
a selective sodium glucose co-transporter 2 (SGLT2) inhibitor, blocks the
reabsorption of glucose by the kidney, increasing glucose excretion, and
lowering blood glucose levels in people with diabetes who have elevated blood
glucose levels.

"We are pleased with the positive recommendation from the committee and look
forward to working with the FDA to bring this important new therapy to
patients in the U.S. to help them manage their type 2 diabetes," said Peter
Stein, M.D., Head, Metabolism Development, Diabetes Disease Area Leader,
Janssen. "Today's outcome represents an important step toward achieving that
goal."

Data presented at today's advisory committee meeting included results from the
comprehensive global Phase 3 clinical program, which enrolled 10,285 patients
in nine studies; it is the largest late-stage development program for an
investigational pharmacologic product for the treatment of type 2 diabetes
submitted to health authorities to date. Canagliflozin was evaluated at 100 mg
and 300 mg once-daily doses in placebo- and active comparator-controlled
studies, as well as three large studies in special populations: older
patients, patients with moderate renal impairment, and patients who had or
were at risk for cardiovascular disease. Results showed that in addition to
the improvements in glycemic control, both doses of canagliflozin were
associated with weight loss and reductions in blood pressure across clinical
studies.

Canagliflozin was generally well tolerated. It has specific safety and
tolerability issues that were well characterized in this development program
(such as the genital mycotic infections, urinary tract infections) and can be
well managed by the physician, and for some of these issues by the patient.

Janssen presented data from Phase 3 studies at the American Diabetes
Association (ADA) in Philadelphia in June, at the European Association for the
Study of Diabetes (EASD) in Berlin in October, and at the World Congress on
Controversies to Consensus in Diabetes, Obesity, and Hypertension (CODHy) in
Barcelona in November.

The FDA will consider the advisory committee recommendation in its review of
the New Drug Application (NDA) for canagliflozin that was submitted by Janssen
on May 31, 2012, though the FDA is not bound to follow it.

Janssen and its affiliates have rights to canagliflozin through a license
agreement with Mitsubishi Tanabe Pharma Corporation. Janssen Pharmaceuticals,
Inc. and its affiliates have marketing rights in North America, South America,
Europe, the Middle East, Africa, Australia, New Zealand, and parts of Asia.

About Type 2 Diabetes

The ADA estimates that 26 million Americans have type 2 diabetes. Type 2
diabetes is a chronic condition that affects the body's ability to metabolize
sugar, or glucose, and is characterized by the inability of pancreatic beta
cell function to keep up with the body's demand for insulin. In most people
with type 2 diabetes, obesity causes resistance of the body to the action of
insulin, and if the pancreatic beta cell cannot produce enough insulin,
hyperglycemia and type 2 diabetes ensue.

If left uncontrolled, type 2 diabetes can lead to serious long-term
microvascular complications such as nerve disease leading to amputation,
retinopathy resulting in blindness and nephropathy causing end-stage renal
disease. Improved glycemic control has been demonstrated to reduce the onset
and progression of these complications. About half of patients with type 2
diabetes do not achieve levels of glucose control recommended by their doctor.

About Janssen Research & Development, LLC

At Janssen, we are dedicated to addressing and solving some of the most
important unmet medical needs of our time in oncology, immunology,
neuroscience, infectious diseases and vaccines, and cardiovascular and
metabolic diseases. Driven by our commitment to patients, we develop
innovative products, services and healthcare solutions to help people
throughout the world. Janssen Research & Development, LLC and Janssen
Pharmaceuticals, Inc. are part of the Janssen Pharmaceutical Companies of
Johnson & Johnson. Please visit http://www.janssenrnd.com for more
information.

(This press release contains "forward-looking statements" as defined in the
Private Securities Litigation Reform Act of 1995. The reader is cautioned not
to rely on these forward-looking statements. These statements are based on
current expectations of future events. If underlying assumptions prove
inaccurate or unknown risks or uncertainties materialize, actual results could
vary materially from the expectations and projections of Janssen Research &
Development, LLC, any of the other Janssen Pharmaceutical Companies and/or
Johnson & Johnson. Risks and uncertainties include, but are not limited to,
general industry conditions and competition; economic factors, such as
interest rate and currency exchange rate fluctuations; technological advances,
new products and patents attained by competitors; challenges inherent in new
product development, including obtaining regulatory approvals; challenges to
patents; changes in behavior and spending patterns or financial distress of
purchasers of healthcare products and services; changes to governmental laws
and regulations and domestic and foreign health care reforms; trends toward
health care cost containment; and increased scrutiny of the healthcare
industry by government agencies. A further list and description of these
risks, uncertainties and other factors can be found in Exhibit 99 of Johnson &
Johnson's Annual Report on Form 10-K for the fiscal year ended January 1,
2012. Copies of this Form 10-K, as well as subsequent filings, are available
online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None
of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertake to
update any forward-looking statements as a result of new information or future
events or developments).

Media contacts:
Christina Chan
Phone: (908) 927-5769
cchan20@its.jnj.com

Bill Foster
Phone: (908) 704-4404
wfoster@its.jnj.com

Investor contacts:
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Phone: (732) 524-2524

Louise Mehrotra
Phone: (732) 524-6491

SOURCE Janssen Research & Development, LLC

Website: http://www.janssenrnd.com
 
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