Pfizer Combo Pill Gets USFDA Approval
The United States Food and Drug Administration has granted Pfizer approval to market its dual- therapy medicine amlodipine besylate/atorvastatin calcium for the simultaneous treatment of hypertension and high cholesterol.
"This is major advance for the millions of patients who concomitantly suffer from two serious medical conditions as it combines two leading medications, each with extensive worldwide experience," said Dr. Joe Feczko, president of Worldwide Development at Pfizer. "Despite an abundance of available therapies, millions of patients continue to have uncontrolled hypertension and high cholesterol. By treating both conditions at the same time, physicians can help patients reduce their risk of developing cardiovascular disease."
Recent guidelines issued by the National Cholesterol Education Program in the US encourage physicians to aggressively treat patients who have both high blood pressure and high cholesterol, especially those with known coronary heart disease.
"Treating patients with multiple risk factors is extremely challenging, and we are not doing a good job at getting [them] to their goals and are therefore leaving them at increased risk," said William Frishman, professor of medicine at New York Medical College and director of medicine at Westchester Medical Center. "Therapeutic interventions like this are a significant step forward, and this could be an important new agent for patients and physicians."
Pfizer
J & J Hosts Forum on Tampon Use
Johnson & Johnson Philippines recently held a forum on "Advancing Women's Health Care," during which the advantages of using tampons and the misconceptions concerning its use were discussed.
Among the issues discussed was a Yale University School of Medicine study on tampon use and sexual activity, orgasm, and decreased risk for endometriosis. Dr. Harvey Kliman, one of the authors, said that the backflow of menstrual fluid in the pelvic cavity or "retrograde menstruation" is believed to cause endometriosis, and that tampon use, douching, and sexual activity during menstruation could heighten the condition. However, the study, published by the Gynecological and Obstetric Investigation journal, seemed to suggest the contrary.
The study showed that among the 2,016 women who participated in the study, those who used tampons more often than any other product for menstrual protection were 2.6 times less likely to have endometriosis. It concluded that "tampon use during menstruation may confer protection against endometriosis."
Also taken up in the forum was a University of Washington study from the Journal of Infectious Diseases. The study showed that women who use tampons have high levels of vaginal lactobacilli, which offered protection against bacterial vaginosis. The finding suggested that tampon use is likely to encourage the growth of the friendly bacteria.
The forum was part of Johnson & Johnson's efforts to raise awareness and correct misconceptionson tampon use.
Noting social barriers to tampon use, Dr. Robert Chase, Johnson & Johnson director for scientific and medical affairs, said there are not unique to the Philippines. "When tampons were first introduced in Germany, the women also had some resistance because in every culture there is a little bit of taboo about touching yourself and inserting something internally," he said.
Johnson & Johnson markets o.b. Tampons, the first widely available tampon brand in the Philippines. Johnson & Johnson officials see a growing market for it.
"We have done intensive market research among local women and found out that many Filipinas, particularly those belonging to the younger groups, have more active lifestyles today. They are more confident, are exposed to modern technology, and welcome the type of sanitary protection offered by o.b. Tampons because it gives them the kind of freedom they need particularly during their period," said Tina Sabarre, Johnson & Johnson group brand manager for women's health and oral wound franchise.
BSMG Worldwide
Erbitux Okayed for Marketing in Europe
DARMSTADT, Germany
The European Commission has granted marketing approval for cetuximab (Erbitux), a new treatment for metastatic colo-rectal cancer. Erbitux is the first monoclonal antibody specifically targeting the epidermal growth factor receptor (EGFR) to gain marketing authorization. It is licensed for use in combination with irinotecan for the treatment of patients with EGFR-expressing metastatic colorec-tal cancer after failure of irinotecan-including cytotoxic therapy.
Erbitux will be available in all 25 member-states of the European Union as well as Iceland and Norway in accordance with local legal regulations.
"We are confident that Erbitux represents a significant step forward to meeting a large, and increasing, unmet medical need," said Prof. Bernhard Scheuble, chief executigve officer of Merck KGaA. "The development of Erbitux is central to Merck's commitment to people with cancer and to those who care for them."
The use of Erbitux is supported by clinical study data showing consistent efficacy in EGFR-expressing colorectal tumors in combination with chemotherapy. The licensed indication is supported primarily by data from the Bowel Oncology and Cetuximab Antibody (BOND) study, which showed that Erbitux, when used in combination with irinotecan, benefited more than half of the patients.
The combined treatment shrank tumors by more than half in 23 percent of patients and stopped tumor growth in an additional 33 percent. Erbitux is the first EGFR inhibitor proven to enhance tumor response in combination with chemotherapy even when this chemotherapy alone is no longer effective.
"The data supporting Erbitux are robust," said Prof. David Cunningham, head of the gastrointestinal and lymphoma units at the Royal Marsden Hospital in London and Surrey, United Kingdom, and lead investigator in the BOND study. "Erbitux has shown efficacy in the most-difficult- to-treat category of patients-those who have metastatic disease and previous treatment failure. The effectiveness of the Erbitux/irinotecan combination is not influenced by the number or type of previously administered chemotherapy regimens."
Erbitux has been approved in Switzerland, the United States and, most recently, in Argentina, Chile, and Mexico.
Merck KGaA licensed the right to market Erbitux outside of the US and Canada and the coexclusive right to market Erbitux in Japan from ImClone Systems Incorporated of New York in 1998.
Merck Media Relations
Vytorin Also Given the Go-Ahead
KENILWORTH, New Jersey
Merck/Schering-Plough Pharmaceuticals said that the United States Food and Drug Administration has approved Vytorin (ezetimibe/simvastatin) for the treatment of high LDL cholesterol in patients with primary hypercholesterolemia or mixed hyperlipidemia as adjunctive therapy to diet when diet alone is not enough.
Vytorin is the first product approved to treat the two sources of cholesterol by inhibiting the production of cholesterol in the liver and blocking the absorption of cholesterol in the intestine, including cholesterol from food, a statement from the two companies said.
In a 12-week, multicenter, double-blind, placebo-controlled clinical study of 1,528 patients with LDL-C levels of 145 mg/dL to 250 mg/dL, Vytorin yielded reductions of 52 percent at the recommended starting dose of 10/20 mg (10 mg ezetimibe/20 mg simvastatin), and 60 percent at the maximum dose of 10/80 mg.
Raymond Gilmartin, chief executive officer of Merck & Co., said Vytorin is the first single cholesterol treatment to provide LDL-C lowering by inhibiting cholesterol production and absorption. "It represents a new treatment alternative for the millions of patients with elevated cholesterol for whom diet alone is not enough."
"With the approval of Vytorin, physicians have a powerful new option that treats the two sources of cholesterol in one tablet," said Fred Hassan, chief executive officer of Schering-Plough.
Full Support for Renal Disease Patients Sought in Kidney Summit
In celebration of Kidney Month, the National Kidney and Transplant Institute (NKTI), the premier institution for transplantation and management of renal diseases in the country, held the Kidney Summit on June 16 at the NKTI auditorium. This was done to discuss the need to look for additional financial support and to expand services to patients diagnosed with kidney failure, those on dialysis, and those who have already undergone transplantation.
In the past few years, renal diseases have risen from 10th to seventh leading cause of death among Filipinos. And although the advent of dialysis and transplantation has helped patients lead relatively normal and healthy lives, their prohibitive cost keeps many Filipinos from receiving proper care.
Dr. Enrique Ona, NKTI executive director, said that the full support of the government is needed. Citing the kind of work the United States put in to bring the legislature to pass a law granting full support to patients with end-stage renal disease (ESRD), Ona said that "for our legislators to understand, we have to go into the next step: kailangan ipaglaban natin ito ng husto."
Dr. Romina Danguilan, head of the Renal Disease Registry, reported the results of the efforts to treat ESRD since 2002. She said: "The acceptance rate for renal replacement therapy has increased from 35 to 65 percent. Dialysis capability in the country also improved. The ratio of increase at the NCR is from 42 to 52 percent, an increase in the region from 6.4 to 8.5 percent. And transplantation has increased from 306 to 407."
Dr. Reynaldo Lesaca of the Human Organ Preservation Effort (HOPE) spoke about the need to expand the donor pool by educating potential donors.
He said that there is a need to allay fears, correct misconceptions, and explain the advantages and the concept of donor swapping among living related donors. Living unrelated donors must also be given an orientation on what they can do to help individuals in need of organs, and what assistance can be given to them. He suggested giving families of deceased donors funeral assistance and professional fee to referring doctors for donor maintenance. He said hospital networking must also be improved and doctors must help explain to people the concept of brain death.
Other lectures dealt on survival of patients with ESRD by Dr. Benita Padilla; treatment options for ESRD by Dr. Florencio Pine; expanding coverage for ESRD and coverage for catastrophic illness by Ms. Annie Bañaga.
Miles Dumalagan
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