| |
Maraviroc approved in Canada to treat HIV, first new class in 10 years
|
| |
| |
The Canadian Press
Health Canada has approved the first drug in the first new class of HIV medications to be brought to market in Canada in a decade.
Celsentri - the brand name for the drug maraviroc - is the first of a class of drugs called CCR5 antagonists to gain regulatory approval.
The drug, made by Pfizer Canada Inc., blocks entry of HIV into the immune system's T cells, reducing the level of the virus in the body. It is approved for use only in people who have already been on other HIV medications; it is not licensed for people who are just starting anti-retroviral drug therapy.
Dr. Philip Berger, an HIV-AIDs specialist, said having a new class of AIDS drugs will help people who have developed resistance to existing therapies. Those are often longtime HIV-AIDS survivors who were started on a single or dual drug regime before the current triple-drug therapy was developed.
"It is definitely an advance for people who have used up all of their current options," said Berger, who practises at St. Michael's Hospital in Toronto. He noted that other new classes of HIV drugs are also in the pipeline.
"For those that began on AZT mono-therapy, for example, 20 years ago or were on dual therapy, which turned out to be ineffective, for that group these new classes of drugs are critical," he said.
Health Canada Approves Novel Treatment for HIV
CELSENTRI(TM) (maraviroc) Tablets Available, First in a New Class of Oral HIV Medicines in More than a Decade
KIRKLAND, QC, Oct. 15 /CNW/ - CELSENTRI (maraviroc) tablets, the first in a new class of oral HIV medicines in more than 10 years, is now approved and available in Canada. CELSENTRI blocks entry of HIV into T cells (CD4+ white blood cells), significantly reducing the level of HIV in treatment-experienced
patients.
"There is an important need for new medicines to help the many Canadians living with HIV/AIDS who are running out of effective medications to control the virus," said Dr. Sharon Walmsley, MSc, FRCPC, Department of Medicine, University of Toronto. "The approval of maraviroc is a significant breakthrough in that it provides a new class that blocks an early step in the viral life cycle that can be used for people with HIV who have developed resistance to our currently available drugs."
CELSENTRI is the first in a class of drugs known as CCR5 antagonists, which block the CCR5 co-receptor, the virus' main entry route into the body's immune cells or CD4+ cells. CELSENTRI stops the CCR5-tropic HIV-1, which is also known as "R5 virus" on the surface of the cell before it enters, rather than fighting the virus inside the cell as do all other classes of oral HIV medicines. A tropism test confirms that a patient is infected with R5 virus.
Earlier this year, Health Canada granted CELSENTRI priority review status. Priority reviews are granted to medicines that would represent an improved overall risk/benefit profile for a disease or condition not adequately managed by a medicine currently available in Canada.
"The approval of CELSENTRI is a Pfizer research and development success story," said Dr. Bernard Prigent, Vice President & Medical Director, Pfizer Canada. "Our hope is that CELSENTRI will offer a much needed new option to many people living with HIV in Canada."
CELSENTRI - A Unique Development Story
The development of CELSENTRI goes back to 1996 when a group of people infected with HIV were found to have a gene mutation that left them immune to the disease. The virus was not able to enter their immune cells. "We developed CELSENTRI after observing research around a small group of people who did not develop symptoms from their HIV. They carried a gene mutation that provided them with a natural protection against HIV," said Dr. Manos Perros, Executive Director, Head of Antiviral Research, Pfizer Global Research and Development. "CELSENTRI was developed by Pfizer scientists to mimic this gene defect in order to provide similar protection against the virus."
Clinical Data Support
Health Canada approval of CELSENTRI is based on six-month data from the ongoing double-blind, placebo controlled clinical trials, MOTIVATE 1 & 2. In the MOTIVATE trials, approximately twice as many patients receiving CELSENTRI combined with an optimized background therapy (OBT) achieved undetectable viral load at 24 weeks compared with those receiving OBT alone. In the trials, patients receiving CELSENTRI with OBT also experienced significantly greater viral load reductions and increases in CD4+ cell counts compared with those receiving OBT alone.
Dosing and Administration
While the recommended dose of CELSENTRI is 300 mg twice a day (BID), this dose is easily adjusted to account for concomitant medications. CELSENTRI can be taken with or without food. CELSENTRI must be given in combination with other antiretroviral medications. For full dosing information, please visit
www.pfizer.ca.
Pfizer's Ongoing Commitment to HIV/AIDS
Pfizer established a multi-national expanded access program (EAP), which was announced earlier this year in Canada. This program provides CELSENTRI in countries where it is not yet commercially available to patients who have limited treatment options due to resistance or intolerance to existing therapies. For the first time in Canada, this program offering access to the drug on a compassionate basis will continue for a limited time allowing patients early access to CELSENTRI until provincial reimbursement programs are determined.
Canadian patients will also continue to have access to CELSENTRI through Pfizer Canada's FIRST RESOURCE(R) program which is designed to assist patients who have private insurance maximize their benefit coverage for medications.
Pfizer is committed to bringing meaningful improvement to the lives of people living with HIV/AIDS and those at risk around the world. This commitment is embodied in Pfizer's products, partnerships, pipeline and philanthropy. Current initiatives include: construction and funding of the Infectious Disease Institute in Kampala, Uganda; the Pfizer Global Health Fellows Program; the Diflucan(R) Partnership Program; and the U.S. Southern States HIV/AIDS Prevention Initiative.
About Pfizer
Pfizer Canada Inc. is the Canadian operation of Pfizer Inc, the world's leading pharmaceutical company. Pfizer discovers, develops, manufactures and markets prescription medicines for humans and animals. Pfizer Inc invests more than US$7 Billion annually in R&D to discover and develop life-saving and life-enhancing medicines. Canadian headquarters of Pfizer Global Pharmaceuticals are in Kirkland, Quebec. For more information, visit www.pfizer.ca.
|
|
| |
| |
|
|
|
