DORVAL, QC, Oct. 4 /CNW Telbec/ - Novartis Pharmaceuticals Canada Inc.
has complied with a request from Health Canada to cease the sales and
marketing of Prexige(*), a COX-2 selective inhibitor for the treatment of
osteoarthritis, with immediate effect.
Following Health Canada's review of all safety and efficacy data
requested from Novartis, Health Canada's assessment has concluded that the
risk of serious liver-related adverse events associated with the use of
Prexige(*) cannot be safely and effectively managed. Health Canada has thus
requested that Novartis stop sales of Prexige(*) in Canada.
Health Canada's approval of Prexige(*) in November 2006 for the treatment
of osteoarthritis of the knee and later in July 2007 for the treatment of
osteoarthritis in all joints was based on the review of a clinical trial
database for Prexige that comprises approximately 40,000 patients, one of the
largest bodies of evidence for any drug in this class.
Novartis submitted clinical data on the liver safety profile of the
proposed 100 mg once-daily dose including studies of up to 12 months of
therapy. The results showed 0.85% of patients had elevations of the liver
enzymes aspartate aminotransferase (AST) and alanine aminotransferase (ALT)
similar to levels observed with currently available NSAIDs. There were also no
cases of jaundice or hepatic failure on Prexige(*) 100 mg once-daily dosing in
the clinical development program.
The submission also included results of the TARGET study involving more
than 18,000 patients, which showed Prexige(*) reduced the incidence of serious
upper gastrointestinal complications by 79% compared to two widely-used
non-steroidal anti-inflammatory drugs (NSAIDs) in patients not taking aspirin.
TARGET also showed Prexige(*) was associated with significantly smaller
increases in blood pressure than the NSAIDs naproxen and ibuprofen, with no
significant difference in cardiovascular events such as heart attack or
Patients in Canada who are taking Prexige(*) should stop taking this
treatment immediately and contact their doctor to seek advice on other
treatment options. Patients should return any remaining Prexige(*) tablets to
their pharmacist for a refund. Physicians are advised not to initiate
treatment with Prexige(*) with new patients, and pharmacists should discontinue
dispensing further prescriptions for Prexige(*).
Healthcare professionals and patients can access information on Prexige(*)
Novartis is advising healthcare professionals, patient groups and all
other impacted stakeholder groups in Canada about the decision.
About Novartis Canada
Novartis Pharmaceuticals Canada Inc., a leader in the healthcare field,
is committed to the discovery, development and marketing of innovative
products to improve the well-being of all Canadians. Novartis Pharmaceuticals
Canada Inc. conducts hundreds of clinical trials across the country seeking
new treatments for cardiovascular disease, diabetes, cancer, ophthalmology and
organ transplantation. In 2006, the Company invested over $69 million in
research and development. Novartis Pharmaceuticals Canada Inc. employs more
than 850 people in Canada and its headquarters are located in Dorval, Quebec.
In addition to Novartis Pharmaceuticals Canada Inc., the Novartis Group in
Canada consists of Novartis Animal Health Canada Inc., Novartis Consumer
Health Canada Inc., (including Novartis Nutrition Corporation) CIBA Vision
Canada Inc. and Sandoz Canada Inc. For further information about Novartis
Canada, please consult http://www.novartis.ca.
Novartis AG (NYSE: NVS) is a world leader in offering medicines to
protect health, cure 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. 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. Novartis is the only company
with leadership positions in these areas. In 2006, the Group's businesses
achieved net sales of USD 37.0 billion and net income of USD 7.2 billion.
Approximately USD 5.4 billion was invested in R&D. Headquartered in Basel,
Switzerland, Novartis Group companies employ more than 100,000 associates and
operate in over 140 countries around the world. For more information, please
(*) Prexige is a registered trademark
For further information:
For further information: Jason Jacobs, Communications, Novartis
Pharmaceuticals Canada Inc., (514) 633-7872, Jason.firstname.lastname@example.org