"Profound suppression of the hepatitis B virus is associated with improved outcomes and is a primary treatment goal," said Adrian M. Di Bisceglie, MD, Professor of Medicine and Chief of Hepatology, Division of Gastroenterology and Hepatology, at St. Louis University, and Co-director, St. Louis University Liver Center. "TYZEKA's ability to provide rapid viral suppression in the first 24 weeks of treatment, along with its demonstrated safety and tolerability profile, make it a promising treatment option for appropriate patients."
Data from the pivotal phase III clinical trial known as the GLOBE study compared TYZEKA to lamivudine in 1,367 patients. The primary efficacy endpoint of the GLOBE study was therapeutic response at one year, a composite endpoint coupling viral suppression (serum HBV DNA suppression below 100,000 copies/mL) with either improved liver disease markers (ALT normalization) or loss of detectable hepatitis B e-antigen (HBeAg). In HBeAg-positive patients, therapeutic response was 75 percent among patients treated with TYZEKA and 67 percent for those patients treated with lamivudine, while the response for HBeAg-negative patients after one year was 75 percent vs. 77 percent, respectively. In the GLOBE study, patients who achieved non-detectable HBV DNA levels at 24 weeks were more likely to undergo e-antigen seroconversion, achieve undetectable levels of HBV DNA, normalize ALT, and minimize resistance at one year.
In clinical studies, telbivudine was generally well tolerated with most adverse experiences classified as mild or moderate in severity. Frequently occurring adverse events (> 5%) were upper respiratory tract infection (14%), fatigue and malaise (12%), abdominal pain (12%), nasopharyngitis (11%), headache (11%), blood CPK increased (9%), cough (7%), nausea and vomiting (7%), influenza and influenza-like symptoms (7%), post-procedural pain (7%), diarrhea and loose stools (7%), and pharyngolaryngeal pain (5%). Please see Important Safety Information below.
"Novartis is committed to infectious diseases and the development of new therapies in the treatment of hepatitis," said Alex Gorsky, Head of Pharma North America and CEO, Novartis Pharmaceuticals Corporation. "The approval of TYZEKA demonstrates our dedication to provide additional treatment options to patients and physicians."
About TYZEKA
TYZEKA is indicated for the treatment of chronic hepatitis B in adult patients with evidence of viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
This indication is based on virologic, serologic, biochemical and histologic responses after one year of treatment in nucleoside-treatment-naïve adult patients with HBeAg-positive and HBeAg-negative chronic hepatitis B with compensated liver disease.
Already approved in Switzerland, telbivudine will be marketed as Sebivo® outside the United States. Applications for approval were filed with the European Medicines Agency (EMEA) and the Chinese health authority in the first quarter of 2006.
Important safety information
-- Lactic acidosis and severe hepatomegaly with steatosis, including fatal
cases, have been reported with the use of nucleoside analogues alone or
in combination with antiretrovirals.
-- Severe acute exacerbations of hepatitis B have been reported in
patients who have discontinued anti-hepatitis B therapy, including
TYZEKA. Hepatic function should be monitored closely with both clinical
and laboratory follow-up for at least several months in patients who
discontinue anti-hepatitis B therapy. If appropriate, resumption of
anti-hepatitis B therapy may be warranted.
-- Cases of myopathy have been reported with telbivudine use several weeks
to months after starting therapy. Myopathy has also been reported with
some other drugs in this class. Physicians considering concomitant
treatment with these or other agents associated with myopathy should
weigh carefully the potential benefits and risks and should monitor and
advise patients to report any signs or symptoms of unexplained muscle
pain, tenderness or weakness, particularly during periods of upward
dosage titration. TYZEKA therapy should be interrupted if myopathy is
suspected, and discontinued if myopathy is diagnosed.
-- Because TYZEKA is eliminated primarily by renal excretion,
co-administration of TYZEKA with drugs that affect renal function may
alter plasma concentrations of TYZEKA and/or the co-administered drug.
Dose interval adjustment is recommended in patients with creatinine
clearance < 50mL/min.
-- The safety and efficacy of TYZEKA in liver transplant recipients are
unknown. If TYZEKA treatment is determined to be necessary for a liver
transplant recipient who has received or is receiving an
immunosuppressant that may affect renal function, such as cyclosporine
or tacrolimus, renal function should be monitored both before and
during treatment with TYZEKA.
-- Patients should be advised that treatment with TYZEKA has not been
shown to reduce the risk of transmission of HBV to others through
sexual contact or blood contamination.
-- Safety and effectiveness of TYZEKA in pediatric patients under the age
of 16 years have not been established.
-- Selected treatment-emergent clinical adverse events of moderate to
severe intensity (Grade 2-4) reported in the GLOBE study with TYZEKA
were: muscle-related symptoms 2%; fatigue/malaise 1%; headache 1%;
pyrexia 1%; abdominal pain <1%; arthralgia <1%; cough <1%; diarrhea
<1%; gastritis <1%.
-- Creatine kinase (CK) elevations were more frequent among subjects
on telbivudine treatment. Grade 3/4 CK elevations occurred in 9% of
telbivudine-treated patients and 3% of lamivudine-treated patients.
-- The optimal duration of treatment with TYZEKA has not been
established. The relationship of initial treatment response to
long-term outcomes such as hepatocellular carcinoma and
decompensated cirrhosis is unknown.
Approximately 1.25 million people in the U.S. are living with chronic hepatitis B, (1) a virus that infects the liver and is 50 to 100 times more infectious than HIV.(2) Chronic hepatitis B affects approximately 350 million people globally.(2)
Idenix/Novartis collaboration
Idenix is co-promoting its hepatitis B product, TYZEKA, and developing its hepatitis B and hepatitis C clinical product candidates (valtorcitabine and valopicitabine, respectively) in collaboration with Novartis Pharma AG under a development and commercialization agreement established in May 2003. Under this agreement, Novartis and Idenix will co-promote TYZEKA and, if successfully developed, valtorcitabine and valopicitabine in the United States, France, Germany, Italy, Spain and the United Kingdom. Novartis has the exclusive right to commercialize licensed approved products in the rest of the world.
Novartis is committed to infectious diseases and is developing a portfolio of products with complementary mechanisms of action in the treatment of hepatitis B and C, while working to bring innovation to the treatment of serious hospital infections.
About Novartis
Novartis Pharmaceuticals Corporation develops, manufactures, markets and sells leading innovative prescription drugs used to treat a number of diseases and conditions, including those in the cardiovascular, metabolic, cancer, organ transplantation, central nervous system, dermatological, gastrointestinal and respiratory areas. The company's mission is to improve people's lives by pioneering novel healthcare solutions.
Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG (NYSE: NVS - News), a world leader in offering medicines to protect health, treat disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and enhance the quality of life. Novartis is the only company with leadership positions in both patented and generic pharmaceuticals. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics, human vaccines and leading self-medication OTC brands. In 2005, the Group's businesses achieved net sales of USD 32.2 billion and net income of USD 6.1 billion. Approximately USD 4.8 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 99,000 people and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.
Forward-looking statements
This release contains certain "forward-looking statements" relating to the Group's business, which can be identified by the use of forward-looking terminology such as "promising," "committed," "dedication," "may be," "will," "is developing," or similar expressions, or by express or implied discussions regarding the potential approval of potential approvals of TYZEKA in additional markets, or potential future revenues from TYZEKA. Such forward- looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results with telbivudine to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that TYZEKA will be approved for sale in any additional markets, or that it will reach any particular levels of revenue. Management's expectations regarding TYZEKA could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; uncertainties relating to clinical trials, including new clinical data and additional analysis of existing clinical data; competition in general; government, industry, and general public pricing pressures; the Company's ability to obtain or maintain patent or other proprietary intellectual property protection; Idenix's dependence on its collaboration with Novartis Pharma AG; Idenix's ability to obtain additional funding required to conduct its research, development and commercialization activities; as well as other risks and factors referred to in the Company's current Form 20-F on file with the U.S. Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
References:
(1) Centers for Disease Control and Prevention. Viral hepatitis B fact
sheet. Available at www.cdc.gov/ncidod/diseases/hepatitis/b/fact.htm.
Accessed 12/16/05
(2) World Health Organization. Hepatitis B fact sheet number 204.
Available at http://www.who.int/mediacentre/factsheets/fs204/en/
Accessed 12/16/05
Contact:
Amy Hunter
Novartis Infectious Disease and Transplant Immunology
+1-862-778-6309 (direct)
[email protected]
Source: Novartis Pharmaceuticals Corporation
发表于 2006-10-27 18:44
