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Zolinza (vorinostat) capsules have been approved to treat cutaneous T-cell lymphoma (CTCL), a type of skin cancer, to be used when the disease persists, gets worse, or comes back during or after treatment with other medicines.
Zolinza was approved as part of the FDA's Orphan Drug program, which offers companies financial incentives to develop medications for diseases affecting fewer than 200,000 Americans a year. Every year in the United States, about three in every 1 million people are diagnosed with CTCL.
Evidence of Zolinza's safety and effectiveness was developed in two clinical trials with 107 CTCL patients who received Zolinza after their disease had recurred following other treatments. A response, defined by improvements on a scale that scores skin lesions, occurred in 30 percent of people who received Zolinza and lasted an average of 168 days. The most common serious side effects were blood clot in the lungs (pulmonary embolism), dehydration, deep vein thrombosis, and anemia.
Zolinza is manufactured by Pantheon Inc. in Mississauga, Ontario, Canada, for Merck & Co. Inc. in Whitehouse Station, N.J.
The FDA has approved Januvia (sitagliptin phosphate) tablets, the first diabetes treatment approved in a new class of drugs, DPP-IV inhibitors, that enhances the body's own ability to lower elevated blood sugar.
Januvia was approved in October 2006 to improve blood sugar levels in people with type 2 diabetes. Januvia can be used alone or in combination with two other commonly prescribed oral diabetes medications, metformin or a peroxisome proliferator-activated receptor gamma (PPAR) agonist, when either of these drugs alone, along with diet and exercise, doesn't provide adequate blood sugar control.
Type 2 diabetes is the most common form of the disease, accounting for about 90 percent to 95 percent of all diagnosed cases of diabetes. In type 2 diabetes, the body does not produce enough insulin, or the cells ignore the insulin. Insulin is necessary to take sugar, the basic fuel for cells, from the blood into the cells. Over time, high blood sugar levels can increase the risk for serious complications, including heart disease, blindness, nerve damage, and kidney damage.
Januvia prolongs the activity of proteins that increase the release of insulin after blood sugar rises, such as after a meal. Januvia blocks an enzyme called dipeptidyl peptidase IV, or DPP-IV, which breaks down these proteins, leading to better blood sugar control.
Januvia was examined in 2,719 people with type 2 diabetes in studies lasting from 12 weeks to more than a year. The studies demonstrated improved blood sugar control when Januvia was used alone, or with metformin or a PPAR agonist in people whose blood sugar was not managed satisfactorily with either of these drugs.
The most common side effects in studies were upper respiratory tract infection, sore throat, and diarrhea.
Januvia is manufactured by Merck & Co. Inc. of Whitehouse Station, N.J.
The FDA has approved the first generic version of MetroGel-Vaginal (metronidazole vaginal gel), a treatment for bacterial vaginosis.
Bacterial vaginosis is a condition in women that is characterized by vaginal discharge and results from an overgrowth of bacteria in the vagina.
"Metronidazole vaginal gel is a widely-used antibacterial preparation, and its generic version can bring significant savings to the millions of Americans with bacterial vaginosis," said Gary J. Buehler, director of the FDA's Office of Generic Drugs, after the drug's approval in November 2006.
Metronidazole Vaginal Gel, 0.75%, is manufactured by QLT USA Inc. in Fort Collins, Colo.
Aricept (donepezil) has been approved by the FDA for treating severe dementia in patients with Alzheimer's disease. Aricept was previously approved for the treatment of mild-to-moderate dementia of the Alzheimer's type. With this latest approval in October 2006, Aricept became the first product approved for the treatment of all degrees of severity of the disease.
Alzheimer's disease is a devastating, age-associated brain disorder that affects an estimated 4.5 million Americans. The FDA approved Aricept to treat patients with mild- to-moderate Alzheimer's disease 10 years ago after two clinical trials demonstrated that patients receiving the drug performed better than patients who received placebo.
The October 2006 approval is based on two additional randomized, placebo-controlled, 24-week clinical studies conducted in Sweden and Japan in more than 500 patients with severe Alzheimer's disease. In these studies, the effectiveness of treatment with Aricept was determined by evaluating the patients' cognitive functions, such as memory, language, orientation, and attention, as well as their overall functioning. The results showed that patients on Aricept performed better on both measures, compared with placebo.
Aricept is manufactured by Eisai Inc. of Teaneck, N.J.
The FDA has approved Risperdal (risperidone) orally disintegrating tablets, an adult antipsychotic drug, for the symptomatic treatment of irritability in autistic children and adolescents. The October 2006 approval is the first for the use of a drug to treat behaviors associated with autism in children. These behaviors fall under the general heading of irritability, including aggression, deliberate self-injury, and temper tantrums.
"This approval should benefit many autistic children, as well as their parents and other care givers," says Steven Galson, M.D., director of the FDA's 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 5 years to 16 years. Ninety percent of the patients were 5 to 12 years. 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. The most common side effects of Risperdal included drowsiness, constipation, fatigue, and weight gain.
Risperdal is marketed by Janssen, L.P. in Titusville, N.J.
The FDA has announced a partnership with Duke Clinical Research Institute (DCRI) to develop a new generation of tools to identify the potential effects that drugs and devices may have on the heart. The research will be conducted using a virtual electronic database of more than 200,000 electrocardiograms (ECGs) amassed by the agency from clinical trial data submitted as part of new drug applications.
The FDA and the DCRI are developing a consortium with members of academia, patient advocacy groups, other government and nonprofit organizations, and industry to coordinate and support a variety of research projects involving ECGs obtained in clinical trials.
Research shows that women are at higher risk of abnormal heartbeats (arrhythmias), but it is not known whether this difference in susceptibility is related to different responses to drugs. Among the first applied projects the consortium will address is a review of gender differences in the effects of drugs on the ECG. A second research project will evaluate current methods of measuring ECGs and develop criteria to determine the best method to be used in a particular research study.
In October 2005, the FDA and the DCRI cosponsored the first in a series of meetings on improving the evaluation of cardiac safety during product development. This partnership is part of the FDA's Critical Path Initiative, an effort to modernize the drug development process.
The FDA has issued a final guidance on quality systems, a set of formalized practices and procedures to ensure quality of human and veterinary drugs and human biological drug products during manufacturing. This guidance enhances the FDA's current requirements for ensuring manufacturing quality known as the current Good Manufacturing Practices regulations.
Following the guidance contained in the document "Quality Systems Approaches to Pharmaceutical Current Good Manufacturing Practice (cGMP) Regulations" should help manufacturers maintain consistent high quality and improve efficiency. The guidance, issued in September 2006, demonstrates to pharmaceutical manufacturers the benefits of incorporating modern quality principles, which should foster technical advancements into their manufacturing processes to better ensure the safety and effectiveness of drugs for people and animals.
The aim also is to help produce drugs more efficiently, which should help lower costs and prevent shortages of critical medicines due to manufacturing failures that can result in production stoppages and recalls.
The FDA will continue to monitor manufacturing plants through its inspection program and will continue to advance the training of its investigators in the latest technologies.
The FDA has approved the APTIMA HIV-1 RNA Qualitative Assay, manufactured by Gen-Probe Inc. of San Diego. The APTIMA assay, which detects the RNA—the nucleic acid or genetic material—of the HIV-1 virus, is the first test approved for the detection of HIV-1 RNA to help diagnose HIV-1 infection. HIV-1 is the main virus that causes AIDS.
"This product offers medical diagnostic laboratories the ability to perform a gene-based test for HIV-1 that, until now, was only available as part of a larger kit used to screen blood and plasma donors," says Jay Epstein, M.D., director of the Office of Blood Research and Review in the FDA's Center for Biologics Evaluation and Research.
"This test also can detect infection with HIV-1 earlier than HIV antibody tests when used to detect primary HIV-1 infection."
Approved in October 2006, this test has important implications for medical diagnostic use because it could be a potential alternative to the traditional Western blot test now used to confirm HIV-1 infection when screening tests for HIV-1 antibodies are positive. In addition, the Western blot can, in some instances, be difficult to interpret and may not always provide a conclusive result. In such cases, the APTIMA test may be helpful in HIV-1 diagnosis. The APTIMA test can also be used in clinical laboratories and public health facilities to detect early HIV-1 infection, before the appearance of antibodies to HIV-1.
The sensitivity of the APTIMA assay is comparable to that of FDA-approved viral load assays that measure the amount of HIV-1 virus circulating in the blood of patients with established HIV-1 infection to monitor the treatment and progression of AIDS. Unlike the viral load tests, the APTIMA test has been approved for the diagnosis of primary HIV-1 infection, as well as for the confirmation of HIV-1 infection when tests for antibodies to HIV-1 are positive.
The FDA has approved Vectibix (panitumumab) to treat people with colorectal cancer that has spread to other parts of the body (metastasized) after standard chemotherapy. Vectibix, a monoclonal antibody that binds to a protein called epidermal growth factor receptor (EGFR) on some cancer cells, received an accelerated approval after showing effectiveness in slowing tumor growth and, in some cases, reducing the size of the tumor.
In the United States, it is estimated that 150,000 new cases of colon cancer were diagnosed and that 55,000 deaths occurred from colon and rectal cancer in 2006. About 70 percent of all colorectal cancerous tumors test positive for EGFR.
The approval of Vectibix was based on the results of a clinical trial of 463 people with metastatic cancer of the colon and the rectum after undergoing treatment with the chemotherapy drugs fluoropyrimidine, oxaliplatin, and irinotecan.
People in the trial who took Vectibix, on average, got worse or died 96 days later—33 days longer than in people who received the best standard supportive care. In addition, 8 percent of the people on Vectibix experienced a tumor shrinkage that in some cases exceeded 50 percent of the pre-treatment size of the tumor.
The most serious side effects in studies of Vectibix included pulmonary fibrosis, severe skin rash complicated by infections, infusion reactions, abdominal pain, nausea, vomiting, and constipation.
Vectibix is manufactured by Amgen Inc. in Thousand Oaks, Calif.
In a separate action, the FDA approved the use of Avastin (bevacizumab), in combination with carboplatin and paclitaxel, for the initial treatment of people with unresectable, locally advanced, recurrent or metastatic, non-squamous, non-small cell lung cancer. This approval was based on an increase in survival time when Avastin was added to a standard chemotherapy regimen.
Non-small cell lung cancer accounts for 75 percent of the 174,400 new cases of lung cancer that are expected to be diagnosed this year. Lung cancer is the leading cause of cancer-related death in men and women.
In a clinical trial of more than 800 patients who had not received prior chemotherapy, the median overall survival time for people taking Avastin plus carboplatin and paclitaxel was 12.3 months versus 10.3 months for those receiving only carboplatin and paclitaxel.
The most serious side effects associated with Avastin in the trial, including some that were fatal, were gastrointestinal perforation, wound healing complications, hemorrhage, blockage of the arteries, abnormally high blood pressure, albumin deficiency in the blood, and congestive heart failure.
Avastin, in combination with a specific type of chemotherapy, was previously approved for first- or second-line treatment of people with metastatic cancer of the colon or rectum.
Avastin is manufactured by Genentech Inc. in South San Francisco, Calif.
Tyzeka (telbivudine) has been approved for the treatment of adults with chronic hepatitis B, a serious viral infection that attacks the liver and can cause lifelong infection, scarring of the liver (cirrhosis), and eventually liver cancer, liver failure, and death. Tyzeka is a new molecular entity, meaning an active substance that has never before been approved for marketing in any form in the United States.
Tyzeka, approved in October 2006, was studied in a yearlong international clinical trial in 1,367 people with chronic hepatitis B. Three-quarters of the trial participants were male, and all participants were 16 years of age or older. The trial produced evidence of antiviral effectiveness, including the suppression of hepatitis B virus (HBV) and improvement in liver inflammation comparable to Epivir-HBV (lamivudine), one of five other medications approved to treat people with chronic hepatitis B.
HBV is spread when blood from an infected person enters the body of a person who is not infected, sometimes by sexual contact or by blood contamination. Tyzeka is not a cure for hepatitis B, and long-term treatment benefits are unknown.
Most of the side effects of Tyzeka reported in clinical studies were mild to moderate. The most common were elevated creatinine phosphokinase (CPK), an enzyme present in muscle tissue and a marker for the breakdown of muscle tissue, upper respiratory tract infection, fatigue, headache, abdominal pain, and cough.
Among drugs in the same class as Tyzeka, some cases have been reported of too much acid in the body due to buildup of lactic acid (lactic acidosis) and to severe enlargement and accumulation of fat in the liver, including fatal cases.
Tyzeka is manufactured by Novartis Pharma Stein AG, Stein, Switzerland, and marketed and distributed by Idenix Pharmaceuticals Inc., Cambridge, Mass.
Omnaris (ciclesonide) nasal spray was approved by the FDA in October 2006 to treat nasal symptoms associated with seasonal and perennial allergic rhinitis in adults and children 12 years of age and older.
Commonly known as hay fever, allergic rhinitis is the medical term for the inflamed, runny nose that's the main symptom of allergies. Seasonal allergic rhinitis is the most common allergic disease. About 35 million Americans suffer from this condition. The ailment's classic symptoms are watery nasal discharge, fits of sneezing, and itching that can affect not just the nose but the roof of the mouth, throat, and the Eustachian tubes, which connect the middle ear to the back of the throat.
Although the precise way Omnaris works is unknown, the drug is a corticosteroid. Corticosteroids are hormone-like drugs that suppress the immune response. The safety and efficacy of Omnaris nasal spray were studied in four randomized placebo-controlled clinical trials ranging in duration from two weeks to a year. The studies assessed how well Omnaris treated symptoms (runny nose, nasal itching, sneezing, and nasal congestion) in patients with hay fever. The results of these trials showed that patients treated with Omnaris nasal spray had an 8 percent to 10 percent greater reduction in nasal symptoms, compared with placebo. The difference between Omnaris nasal spray and placebo was significant.
The most common side effects of Omnaris in clinical studies were headache, nosebleeds, and inflammation of the nose and throat linings.
Omnaris is manufactured by ALTANA Pharma US Inc. of Florham Park, N.J.