Favorable Vote from FDA Advisory Committee on Benefit/Risk of Crestor (rosuvastatin calcium) in JUPITER Study
WILMINGTON, Del., Dec. 15 /PRNewswire-FirstCall/ -- The U.S. Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) today voted 12 yes, 4 no, and 1 abstention that AstraZeneca has established sufficient benefit to offset the observed risks to support the use of CRESTOR® (rosuvastatin calcium) in individuals meeting the following criteria:
-- Men greater than or equal to 50 years, women greater than or equal to
60 years;
-- Fasting LDL < 130 mg/dL; hsCRP greater than or equal to 2.0 mg/L;
Triglycerides <500 mg>
The review, based on results of the JUPITER (Justification for
the Use of statins in Prevention: an Intervention Trial Evaluating
Rosuvastatin) study, is part of the FDA's evaluation of the
supplemental New Drug Application (sNDA) filed by AstraZeneca in
April 2009 to update the CRESTOR Prescribing Information with
information about the impact of CRESTOR on reducing the risk of
cardiovascular events.
"AstraZeneca welcomes the Advisory Committee's positive vote,"
said Howard Hutchinson, M.D., Chief Medical Officer, AstraZeneca.
"Today's discussions will help guide our ongoing dialogue with the
FDA regarding our request for an indication that supports the use
of CRESTOR for the prevention of cardiovascular disease in patients
with an increased risk of experiencing cardiovascular events."
The FDA Advisory Committee also discussed four non-voting items
related to a range of other observations in JUPITER, including
adverse events and whether the JUPITER trial identified an
appropriate new target patient population.
The FDA frequently convenes advisory committee meetings to
obtain independent expert guidance and opinions on clinical
matters. While the FDA is not required to follow this guidance, the
agency usually takes the advice into consideration when rendering
its final decisions on pending applications and other public health
matters.
ABOUT JUPITER:
Results from JUPITER (Justification for the Use of statins in
Prevention: an Intervention Trial Evaluating Rosuvastatin) were
originally presented in November 2008 at the American Heart
Association's Annual Scientific Sessions, and published by the New
England Journal of Medicine, evaluated the impact of rosuvastatin
20 mg on reducing CV events (combined risk of myocardial
infarction, stroke, arterial revascularization, hospitalization for
unstable angina, or death from CV causes).
JUPITER was a long-term, randomized, double-blind,
placebo-controlled, large-scale study of 17,802 patients designed
to determine if rosuvastatin 20 mg decreases the risk of myocardial
infarction, stroke and other cardiovascular events in patients with
LDL-C < 130 mg/dL but at increased cardiovascular risk as
identified by age and elevated high-sensitivity C-reactive protein
(hsCRP). The majority of patients had at least one other risk
factor including hypertension, low HDL-C, family history of
premature coronary heart disease (CHD) or smoking. hsCRP is a
recognized marker of inflammation which is associated with an
increased risk of atherosclerotic cardiovascular events.
JUPITER is a part of AstraZeneca's extensive GALAXY clinical
trials program, designed to address important unanswered questions
in statin research. Currently, more than 65,000 patients have been
recruited from 55 countries worldwide to participate in the GALAXY
Program.
ABOUT CRESTOR (ROSUVASTATIN CALCIUM):
CRESTOR is indicated as an adjunct to diet to reduce elevated
Total-C, LDL-C, ApoB, non-HDL-C, and TG levels and to increase
HDL-C in patients with primary hyperlipidemia and mixed
dyslipidemia. CRESTOR is also indicated as an adjunct to diet to
slow the progression of atherosclerosis in adult patients as part
of a treatment strategy to lower Total-C and LDL-C to target
levels. CRESTOR is not approved to reduce cardiovascular morbidity
and mortality.
IMPORTANT SAFETY INFORMATION:
CRESTOR is contraindicated in patients with a known
hypersensitivity to any component of this product, in patients with
active liver disease, which may include unexplained persistent
elevations of hepatic transaminase levels, in women who are
pregnant or may become pregnant, and in nursing mothers.
Cases of myopathy and rhabdomyolysis with acute renal failure
secondary to myoglobinuria have been reported with HMG-CoA
reductase inhibitors, including CRESTOR. These risks can occur at
any dose level, but are increased at the highest dose (40 mg).
CRESTOR should be prescribed with caution in patients with
predisposing factors for myopathy (eg, age greater than or equal to
65 years, inadequately treated hypothyroidism, renal impairment).
The risk of myopathy during treatment with CRESTOR may be increased
with concurrent administration of some other lipid-lowering
therapies (fibrates or niacin), gemfibrozil, cyclosporine, or
lopinavir/ritonavir.
Therapy with CRESTOR should be discontinued if markedly elevated
CK levels occur or myopathy is diagnosed or suspected. All patients
should be advised to promptly report unexplained muscle pain,
tenderness, or weakness, particularly if accompanied by malaise or
fever. It is recommended that liver enzyme tests be performed
before and at 12 weeks following both the initiation of therapy and
any elevation of dose, and periodically (e.g., semiannually)
thereafter. Should an increase in ALT or AST of >3 times ULN
persist, reduction of dose or withdrawal of CRESTOR is recommended.
CRESTOR should be used with caution in patients who consume
substantial quantities of alcohol.
CRESTOR 40 mg should be used only for those patients not
achieving their LDL-C goal with 20 mg. Patients initiating CRESTOR
therapy or switching from another statin should begin treatment
with CRESTOR at the appropriate starting dose.
In the controlled clinical trials database, the most common
adverse reactions were headache (3.7%), myalgia (3.1%), abdominal
pain (2.6%), asthenia (2.5%), and nausea (2.2%).
Please see accompanying full Prescribing Information. If you
have any questions concerning CRESTOR, please contact AstraZeneca
at 1-800-237-8898. CRESTOR is a registered trademark of the
AstraZeneca group of companies.
About AstraZeneca
AstraZeneca (NYSE:AZN)
is engaged in the research, development, manufacturing and
marketing of meaningful prescription medicines and in the supply of
healthcare services. AstraZeneca is one of the world's leading
pharmaceutical companies with global healthcare sales of $31.6
billion and is a leader in gastrointestinal, cardiovascular,
neuroscience, respiratory, oncology and infectious disease
medicines. In the United States, AstraZeneca is a $13.5 billion
dollar healthcare business.
For more information about AstraZeneca in the US or our
AZ&Me(TM) Prescription Savings programs, please visit:
www.astrazeneca-us.com.
(Logo: http://www.newscom.com/cgi-bin/prnh/20091027/PH99766LOGO
)
Photo: http://www.newscom.com/cgi-bin/prnh/20091027/PH99766LOGO
Source: AstraZeneca
CONTACT: Media, Donna Huang, +1-302-885-6396, Julia Walker,
+1-302-885-5172, Neil McCrae, +44-207-304-5045 (24 hours), Chris
Sampson, +44-20-7304-5130 (24 hours), Sarah Lindgreen,
+44-20-7304-5033 (24 hours), or Abigail Baron, +44-20-7304-5034 (24
hours); or Investor Inquiries US, Ed Seage, +1-302-886-4065,
mobile: +1-302-373-1361, or Jorgen Winroth, +1-212-579-0506,
mobile: +1-917-612-4043; or Investor Inquiries UK, Jonathan Hunt,
+44-207-304-5087, mobile: +44-7775-704032, Karl Hard,
+44-207-304-5322, mobile: +44-7789-654364, or Clive Morris,
+44-207-304-5084, mobile: +44-7710-031012, all of AstraZeneca
Web Site: http://www.astrazeneca-us.com/
Posted: December 2009
