FDA approves Risperdal for autism
Risperidone (Risperdal) orally disintegrating tablets, an adult antipsychotic drug, has been approved for the symptomatic treatment of irritability in autistic children and adolescents. The approval granted by the United States Food and Drug Administration (FDA) is the first for the use of a drug to treat behaviors associated with autism in children. These behaviors are included under the general heading of irritability, and include aggression, deliberate self-injury, and temper tantrums.
"This approval should benefit many autistic children as well as their parents and other care givers," said Dr. Steven Galson, director of the FDA Center for Drug Evaluation and Research. "Our agency strongly encourages the development of appropriate pediatric labeling for adult drugs, and Risperdal is a welcome addition to the growing number of such products that have been shown to have an appropriate risk-benefit profile when tested in children."
Risperdal has been approved since 1993 for the short-term treatment of adults with schizophrenia, and since 2003 for the short-term treatment of adults with acute manic or mixed episodes associated with extreme mood swings.
The product's effectiveness in the symptomatic treatment of irritability associated with pediatric autistic disorders was established in two eight-week, placebo-controlled trials in 156 patients ages five to 16 years, 90 percent of whom were five to 12 years old. The results, which were evaluated using two assessment scales, showed that children on Risperdal achieved significantly improved scores for certain behavioral symptoms of autism compared with children on placebo.
Risperdal is marketed by Janssen Pharmaceuticals.
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Noxafil okayed for fungal infections
The United States Food and Drug Administration approved posaconazole (Noxafil) to prevent fungal infections caused by Aspergillus and Candida. The FDA approved the drug for use in patients who have weakened immune systems following bone-marrow transplants or chemotherapy for cancer.
"Most healthy individuals are unaffected by these common fungi," said Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research. "However, individuals with severely weakened or abnormal immune systems may become seriously ill when exposed. These infections are often fatal for this population."
Noxafil, manufactured by Schering Corporation, is an antifungal that contains an active substance never before approved for marketing in any form in the US. In two randomized, controlled studies of patients who had compromised immunity and were at high risk for invasive fungal infections, the patients who received Noxafil had comparable or lower rates of invasive Aspergillus and Candida infections than patients who received other antifungal medications.
The most common side effects were nausea, vomiting, diarrhea, rash, a decrease in potassium blood levels and platelet counts, and abnormalities in liver-function tests. Rare adverse events possibly related to the drug include QTc prolongation (abnormal heart rhythm) and liver-function impairment.
Noxafil must be taken with a full meal or nutritional supplement to allow adequate absorption of the drug into the body so it can take effect. Noxafil has been shown to interact with several medications, including drugs that suppress the immune system, and these reactions may be serious.
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Tacrolimus safe in atopic dermatitis
The treatment of such chronic skin conditions as atopic dermatitis has been a significant challenge to researchers, clinicians, and most importantly, patients. While traditional treatment has shown efficacy, complaints of adverse events have contributed to patients not continuing with treatment.
Dr. Alan Fleischer, chair of the dermatology department of Wake Forest University School of Medicine, visited the country recently to present the latest scientific data on the long-term management of atopic dermatitis and discussed the efficacy and safety of a relatively new treatment option for atopic dermatitis, the calcineurin inhibitor tacrolimus. Fleischer was the key speaker during the first joint meeting of the Philippine Dermatological Society and the Philippine Society for Asthma, Allergy, and Immunology in July.
Atopic-dermatitis cases, along with other allergic diseases, have slowly been increasing in rate for the past years globally. Topical corticosteroids have been the drugs of choice in the management of atopic dermatitis. However, patients have occasionally raised the issue of corticosteroid-related adverse events.
Long-term corticosteroid use has been associated with skin atrophy and disruption in collagen synthesis. Studies have also shown that topical corticosteroids don't have 100-percent clearance rates.
But the advent of topical immunomodulators, such as the calcineurin inhibitor tacrolimus, has tried to address these complaints. In studies conducted abroad, of which Fleischer was part of the investigating team, tacrolimus was shown to have equal potency with that of a medium-potency corticosteroid and a higher efficacy than a lower-potency steroid. In addition, tacrolimus was found to be safe for use in children less than two years old, which cannot be said for corticosteroids.
Another benefit of this drug is its efficacy in long-term treatment, whether in terms of efficacy or safety. Skin atrophy, a common complaint with long-term corticosteroid use, is virtually absent in tacrolimus use. Although tacrolimus has been found to result in itchiness and burning upon application, these effects can be significantly reduced, if not totally eliminated, by pretreating the patient with a corticosteroid for a few days before introducing tacrolimus.
Aside from atopic dermatitis, other chronic diseases for which tacrolimus can be used include vitiligo, seborrheic dermatitis, psoriasis, lichen sclerosis, and eczema.
M Cherrie Cruz
Gardasil gets BFAD green light
Gardasil, the first vaccine against cervical cancer, has won approval from the Bureau of Food and Drugs (BFAD) for use among Filipino girls and women nine to 26 years old. The BFAD green light, coming at the heels of the approval last month in the European Union, making the Philippines among the first to take advantage of the vaccine's life-saving potential.
Gardasil offers hope to thousands of Filipino women at risk of contracting the human papillomavirus (HPV), the leading cause of cervical cancer. Cervical cancer is the second leading cause of cancer deaths among women, next to breast cancer. Every day, at least 10 Filipino women die of cervical cancer and 20 are diagnosed with the disease. The Philippine Cancer Society estimated that last year, 7,277 new cases of cervical cancer were diagnosed while 3,807 Filipino women died of the disease.
The vaccine was approved last month in all 25 members of the European Union, following earlier approvals in the United States, Mexico, Canada, Australia, New Zealand, Taiwan, Brazil, Togo, Malaysia, and Hong Kong.
BFAD approved Gardasil for the prevention of cervical cancer, vulvar and vaginal cancer, cervical precancers (cervical intraepithelial neoplasia II/III and adenocarcinoma in situ), vulvar precancers, and vaginal precancers (vaginal intraepithelial neoplasia II/III) caused by HPV types 16 and 18, as well as for genital warts and low-grade cervical lesions caused by HPV types 6, 11, 16 and 18.
"Merck, Sharp & Dohme is proud to introduce this breakthrough vaccine that can help prevent Filipino women from developing cervical cancer," said Dr. Cesar S. Recto II, MSD medical director. "Bringing forward this life-saving scientific advance is yet another testament to MSD's long-standing mission to research and develop novel vaccines and medicines that can greatly improve public health."
"The vaccine is a major health breakthrough-the first vaccine specifically designed to prevent cancer-and is approved to prevent not only cervical cancer but also genital warts," commented Dr. Susan Nagtalon, president of the Philippine Obstetrics and Gynecological Socitey. "Use of the vaccine can help significantly reduce the human and economic burden of cervical cancer throughout the world, in this generation and future generations."
The efficacy Gardasil was evaluated in four placebo-controlled, double-blind, randomized phase-II and -III studies that involved 20,541 women 16 to 26 years old. The studies showed that the vaccine prevented 100 percent of HPV16- and 18-related cervical precancers and noninvasive cervical cancers. None of the 8,487 women who received the vaccine developed cervical cancer compared with 53 cases in the 8,460 women who received placebo. The vaccine also prevented 99 percent of cases of genital warts and 100 percent of HPV 16- and 18-related vulvar and vaginal precancers in women not previously exposed to the virus.
Gardasil is marketed by MSD Philippines.
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Caduet lowers 10-year CVD risk
FUKUOKA, Japan
Single-pill amlodipine besylate/atorvastatin calcium (Caduet) may reduce the 10-year risk of having a cardiovascular (CV) event as determined by the Framingham 10-year coronary-heart-disease-risk score by 54 percent in hypertensive patients with elevated levels of low-density lipoproteins (LDL).
Data from the International GEMINI AALA trial further showed that patients across participating countries who took Caduet achieved hypertension and lipid treatment targets as recommended by JNC 7 and NCEP ATP III guidelines. The results were presented recently at the annual scientific meeting of the International Society of Hypertension (ISH).
"This is the first large-scale clinical trial to evaluate the real-world clinical effectiveness of amlodipine besylate/atorvastatine calcium therapy in patients across both Asia and Latin America," said Dr. Hung Fat Tse, GEMINI AALA investigator from University of Hong Kong. "The results show that by taking this new fixed combination with or without an existing antihypertensive regimen, these patients may achieve and maintain blood pressure and lipid goals and more importantly, reduce their estimated 10-year risk of coronary heart disease."
Dr. Hilton Chaves of Brazil's Federal University of Pernambuco said, "The results … provide a compelling rationale for treating patients with hypertension and additional risk factors with amlodipine-besylate/atorvastatin-calcium therapy. This may be an important advance in the evolution of patient management."
GEMINI AALA was a 14-week, open-label, multicenter, titration-to-goal study involving 1,649 patients in 27 countries across the Middle East, Asia, Australia, Africa, and Latin America. The primary end point was the percentage of patients reaching both blood-pressure and LDL targets as defined by JNC 7 and NCEP ATP III guidelines. After treatment, 55.2 percent of patients reached both blood-pressure and LDL goals-significant because generally only nine percent of patients with hypertension and high cholesterol are controlled for both. Mean blood pressure was reduced by 20.2/11.4 mm Hg (13 percent) and mean LDL by 1.1 mmo1/L (29 percent).
A post hoc analysis also was conducted among a subgroup of patients in Eastern Asian countries (excluding India and Pakistan). Primary and secondary efficacy measures were compared between this subgroup and a "non-Asian" subgroup of patients from all other countries. In the Asian subgroup (694 patients), 56 percent of patients reached both blood-pressure and LDL goals, and the mean Framingham 10-year CHD risk score was reduced by 56 percent.
Treatment was well tolerated, with a total of 60 patients (3.6 percent) discontinuing due to adverse events, mostly peripheral edema (9.8 percent), respiratory infection (five percent), headache (3.3 percent), dizziness (3.1 percent), palpitations (1.5 percent), and myalgia (1.5 percent).
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