Full Press Release Details
Approves Kitov's Consensi for Treatment of Osteoarthritis Pain and Hypertension
for millions of Americans offers one pill for treatment of osteoarthritis pain with a built-in antihypertensive
TEL AVIV, Israel, May 31, 2018 / GlobeNewswire/
Kitov Pharma Ltd. (NASDAQ: KTOV; TASE:
KTOV), an innovative biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved Consensi
(amlodipine and celecoxib) oral tablets for marketing.
Consensi is a patent-protected
combination of celecoxib, a non-steroidal anti-inflammatory drug (NSAID), and amlodipine besylate, an antihypertensive calcium
channel blocker. Consensi was approved for once daily use in three dosage forms, corresponding to the current approved dosages
of amlodipine (2.5, 5, and 10 mg) for hypertension and a 200 mg dose of celecoxib for the treatment of osteoarthritis pain.
"We are very pleased with Consensi 's
approval and would like to thank the members of Kitov's team, consultants and investigators, as well as the FDA's Division
of Cardiovascular and Renal Products, for all of their support and assistance," said Dr. J. Paul Waymack, Chairman of
Kitov's Board and Chief Medical Officer. "Consensi provides a safe and effective combination treatment option for
the millions of Americans who suffer from osteoarthritis pain and hypertension.
"Now that Consensi has
been approved for marketing, our clinical and regulatory teams will focus on leveraging their drug development expertise to advance
NT219, an exciting investigational new drug candidate currently in development for various oncology indications."
Isaac Israel, Kitov's CEO, added:
"This approval demonstrates the Kitov team's ability and experience in expertly guiding Consensi through
clinical trials and regulatory review, from Investigational New Drug (IND) submission to FDA approval in less than four years.
50 million Americans suffer from osteoarthritis. About 1 of 3 U.S. adults or about 75 million people have high blood pressure*,
known as the "silent killer" due to the absence of noticeable symptoms. As a result, patients' adherence to the
hypertension treatment regimen is low. We believe that Consensi , as a single pill combination
treatment for osteoarthritis and hypertension, presents a unique
value proposition of potentially increasing treatment adherence.
"We recently expanded
our commercialization network for Consensi by securing a second licensing agreement in Asia with a major Chinese pharmaceutical
company. The FDA approval of Consensi puts us in a stronger position towards securing commercial partnerships for the U.S.
and other key territories."
The FDA-approved Consensi New Drug Application included
the positive results from the Company's Phase III clinical trial. These data demonstrated that
the study met its primary endpoint of showing that the drug lowers daytime systolic blood pressure by at least 50% of the reduction
in blood pressure achieved in patients treated with amlodipine besylate only, with statistical significance of p=0.001. Kitov also
submitted the positive results from its randomized double-blind, placebo-controlled renal function Phase III/IV clinical trial
of Consensi . Data from this study validated the primary efficacy endpoint achieved
in the completed Phase III clinical trial. This study also demonstrated that treatment with Consensi led to a statistically
significant reduction of serum creatinine, a marker of renal function, from its baseline value (p=0.0005), demonstrating improved
renal function in patients treated with the combination. In contrast, neither amlodipine besylate nor placebo lowered creatinine
to a statistically significant level.
According to the US Centers for Disease Control and Prevention (https://www.cdc.gov/bloodpressure/index.htm)
Full US Prescribing Information,
including BOXED WARNING and Medication Guide is available at: www.consensi.com.
Indications and Usage:
Consensi is a combination
of amlodipine besylate, a calcium channel blocker, and celecoxib, a nonsteroidal anti-inflammatory drug (NSAID), indicated for
patients for whom treatment with amlodipine for hypertension and celecoxib for osteoarthritis are appropriate. Lowering blood pressure
reduces the risk of fatal and nonfatal CV events, primarily strokes and myocardial infarctions.
available in a celecoxib strength of 200 mg and is only to be taken once daily.
Important Safety Information (ISI)
The following ISI is based
on the Highlights section of the U.S. Prescribing Information for Consensi . Please consult the full Prescribing Information
for all of the labelled safety information for Consensi .
Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased
risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk
may occur early in the treatment and may increase with duration of use.
is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
NSAIDs cause an increased risk of serious gastrointestinal
(GI) adverse events, including bleeding, ulceration and perforation of the stomach or intestines, which can be fatal. These events
can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer
disease and/or GI bleeding are at greater risk for serious GI events.
Consensi is contraindicated in patients with a known
hypersensitivity to amlodipine, celecoxib or any of its inactive ingredients.
is contraindicated in patients with a known history of asthma, urticaria or other allergic-type reactions after taking aspirin
or other NSAIDs and in the setting of CABG surgery.
Consensi is contraindicated in patients with known
demonstrated allergic-type reactions to sulfonamides.
Significant warnings and precautions related to Consensi
include the following:
Patients should be warned about the potential signs and symptoms
of hepatotoxicity and hepatic failure. Physicians should discontinue Consensi if abnormal liver tests persist or worsen,
or if clinical signs and symptoms of liver disease develop.
Patients taking some antihypertensive medications may have impaired
response to these therapies when taking NSAIDs. Physicians should carefully monitor blood pressure.
Symptomatic hypotension is possible, particularly in patients
with severe aortic stenosis.
Worsening angina and acute myocardial infarction, particularly
in patients with severe obstructive coronary artery disease, is possible.
Physicians should avoid use of Consensi in patients with
severe heart failure.
Physicians should monitor renal function in patients with renal
or hepatic impairment, heart failure, dehydration, or hypovolemia, and avoid the use of Consensi in patients with
advanced renal disease.
Patients should seek emergency help if an anaphylactic reaction
Consensi is contraindicated in patients with aspirin-sensitive
asthma. Monitor patients with preexisting asthma (without aspirin sensitivity).
Physicians should discontinue Consensi at the first
appearance of skin rash or other signs of hypersensitivity.
NSAIDs such as Consensi can cause premature Closure
of Fetal Ductus Arteriosus.
Avoid use in pregnant women starting at 30 weeks of gestation.
Physicians should monitor hemoglobin or hematocrit in patients
with any signs or symptoms of anemia.
Consensi is not recommended in patients with moderate
or severe hepatic impairment or severe renal insufficiency.
Consensi is not recommended in Poor Metabolizers
of CYP2C9 Substrates.
To report SUSPECTED ADVERSE
REACTIONS, contact Kitov Pharma at 1-800-651-6606 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Kitov Pharma (Kitov Pharma Ltd.; NASDAQ/TASE: