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Tuesday, January 29, 2013
Wednesday, January 23, 2013
Exjade (deferasirox) Is Approved By FDA To Remove Excess Iron In Patients With non-transfusion-dependent thalassemia (NTDT) Disorder
For Immediate Release: Jan. 23, 2013
Media Inquiries: Stephanie Yao, 301-796-0394, firstname.lastname@example.org
Consumer Inquiries: 888-INFO-FDA
FDA approves Exjade to remove excess iron in patients with genetic blood disorderFirst imaging companion diagnostic to detect liver iron concentration also clearedThe U.S. Food and Drug Administration today expanded the approved use of Exjade (deferasirox) to treat patients ages 10 years and older who have chronic iron overload resulting from a genetic blood disorder called non-transfusion-dependent thalassemia (NTDT).
NTDT is a milder form of thalassemia that does not require individuals to get frequent red blood cell transfusions. However, over time, some patients with NTDT are still at risk for iron overload that can lead to damage to vital organs.
The FDA is also authorizing marketing of FerriScan as an imaging companion diagnostic for Exjade. The agency previously cleared FerriScan for measuring liver iron concentration (LIC), but its use in Exjade clinical studies to select patients for therapy, and to manage therapy, defined its role as an imaging companion diagnostic necessary for Exjade’s safe and effective use. FerriScan measures LIC non-invasively using magnetic resonance imaging.
An estimated 1,000 people in the United States have thalassemia, according to the National Heart, Lung, and Blood Institute. Thalassemia conditions can cause the body to make fewer healthy red blood cells and less hemoglobin, a protein that carries oxygen to all parts of the body and returns carbon dioxide to the lungs so it can be exhaled. Some patients with thalassemia require frequent transfusions of red blood cells to maintain an acceptable level of hemoglobin. Iron overload is common in these patients.
Exjade was previously approved for treatment of chronic iron overload due to blood transfusions in patients ages 2 years and older, and this approval extends its use to treat patients with NTDT who show iron overload. Exjade should be used in patients with NTDT who have an LIC of at least 5 milligrams of iron per gram of dry liver tissue weight.
Exjade’s new indication is being approved under the FDA’s accelerated approval program, which provides patients earlier access to promising new drugs intended to treat serious or life-threatening illnesses while the company conducts additional studies to confirm the drug’s clinical benefit. Exjade was approved based on clinical data showing it can reduce LIC to less than 5 mg/g dry weight, a surrogate endpoint that is judged reasonably likely to predict a clinical benefit to patients.
“Using our accelerated approval process, FDA is able to expedite the availability of this drug to patients who need to reduce excess iron,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Exjade is the first drug approved to treat patients with NTDT who show iron overload.”
The safety and effectiveness of Exjade to treat chronic iron overload in patients with NTDT were established in two clinical trials designed to measure the number of patients whose LIC was reduced to less than 5 mg/g dry weight after 52 weeks of treatment. In the first trial, 166 patients were randomly assigned to receive 5 mg/kg of Exjade, 10 mg/kg of Exjade, or a placebo daily. Results showed 15 percent and 27 percent of Exjade-treated patients achieved the target LIC, respectively, compared with 4 percent in placebo-treated patients. The second trial contained 133 patients from the first study who received an additional year of Exjade treatment or switched from placebo to Exjade treatment. Thirty-five percent of the evaluable patients in this extension trial achieved the target LIC.
The FDA reviewed data for the FerriScan through the de novo classification process, a regulatory pathway for medical devices that are generally moderate-risk but are not comparable to an already legally marketed device. The FDA’s granting of the de novo request for FerriScan was based largely on data from the Exjade clinical studies that used FerriScan LIC results as the primary outcome measure. Additionally, investigators conducted a 230-patient study that found FerriScan results were as accurate as liver biopsy for measuring LIC.
“The FerriScan device is a non-invasive test that helps physicians to select appropriate patients for Exjade therapy as well as monitor their response to the drug, and discontinue therapy when LIC reaches safe levels,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health.
Exjade is marketed by East Hanover, N.J.-based Novartis. FerriScan is marketed by Resonance Health, based in Australia.
Tuesday, January 22, 2013
The FDA has approved Flublok vaccine for people 18-49 years old making it the first recombinant vaccine for influenza available on the market.
Flublok is a novel protein vaccine for the prevention of seasonal influenza disease and is the first to be made in a 100% egg-free system without growing influenza viruses. According to the company, the vaccine can be made quickly and without any of the infectious risk traditionally associated with vaccine manufacture. They also mentioned that Flublok is highly purified, has three times the amount of active ingredient in traditional influenza vaccines, and contains no preservatives (thimerosal), antibiotics or adjuvants.
“Flublok is truly a modern vaccine, We use advanced scientific technology to make just the active ingredient of the vaccine without any other viral components. This is the first influenza vaccine on the market to do so.” said Manon Cox, CEO of Protein Sciences.
For more information on Flu (Influenza):
For Immediate Release: Jan. 16, 2013
Media Inquiries: Rita Chappelle, 301-796-4672, email@example.comConsumer Inquiries: 888-INFO-FDA, OCOD@fda.hhs.govFDA approves new seasonal influenza vaccine made using novel technology
The U.S. Food and Drug Administration today announced that it has approved Flublok, the first trivalent influenza vaccine made using an insect virus (baculovirus) expression system and recombinant DNA technology. Flublok is approved for the prevention of seasonal influenza in people 18 through 49 years of age.
Unlike current flu vaccines, Flublok does not use the influenza virus or eggs in its production. Flublok’s novel manufacturing technology allows for production of large quantities of the influenza virus protein, hemagglutinin (HA) – the active ingredient in all inactivated influenza vaccines that is essential for entry of the virus into cells in the body. The majority of antibodies that prevent influenza virus infection are directed against HA. While the technology is new to flu vaccine production, it is used to make vaccines that have been approved by the FDA to prevent other infectious diseases.
“This approval represents a technological advance in the manufacturing of an influenza vaccine,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “The new technology offers the potential for faster start-up of the vaccine manufacturing process in the event of a pandemic, because it is not dependent on an egg supply or on availability of the influenza virus.”
Each year, the FDA, World Health Organization, the Centers for Disease Control and Prevention and other public health experts collaborate on the review of influenza disease surveillance and laboratory data collected from around the world in an effort to identify strains that may cause the most illness in the upcoming season. Based on that information and on the recommendations of the FDA’s Vaccines and Related Biological Products Advisory Committee, the FDA selects the different influenza strains each year that manufacturers should include in their vaccines for the U.S. population for the upcoming influenza season. The closer the match between the circulating strains causing disease and the strains in the vaccine, the better the protection against influenza.
Flublok contains three, full-length, recombinant HA proteins to help protect against two influenza virus A strains, H1N1 and H3N2, and one influenza virus B strain.
As it does with all influenza vaccines, the FDA will evaluate Flublok annually prior to use by the public each flu season. The recombinant HA proteins produced in the baculovirus expression system and included in Flublok will be assessed by the FDA.
The effectiveness of Flublok was evaluated in a study conducted at various sites in the United States that compared the use of Flublok in about 2,300 people to a placebo that was given to a control group of similar size. Flublok was about 44.6 percent effective against all circulating influenza strains, not just the strains that matched the strains included in the vaccine.
Flublok’s safety evaluation was conducted in a study of about 2,500 people who were vaccinated with Flublok. The most commonly reported adverse events included pain at the site of injection, headache, fatigue and muscle aches, events also typical for conventional egg-based, inactivated influenza vaccines.
Flublok has a shelf life of 16 weeks from the date of manufacture. Health care providers should check the expiration date before administering Flublok.
Flublok is manufactured by Protein Sciences Corp, of Meriden, Conn.
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Octaplas Approved By FDA For Transfusion Or Plasma Exchange In Patients With Thrombotic Thrombocytopenic Purpura (TTP)
Octaplas has been approved for use in patients with certain medical condition who lacks sufficient levels of clotting proteins. This deficiency could lead to severe bleeding or excessive clotting of the blood. This condition is known as Thrombotic Thrombocytopenic Purpura (TTP), which could be congenital or acquired. It is known to have an incidence of 3.8 per million.
“Over more than 20 years, there have been more than 8 million units of Octaplas® transfused internationally, in more than 2.6 million patients, We look forward to bringing Octaplas® to the U.S. medical community. There have been no reports of Octaplas® being associated with TRALI in voluntarily reported adverse events data from all countries where Octaplas® is approved. The incidence of TRALI from plasma transfusion is not well documented, but has been reduced with the introduction of male-only donors in recent years. However, cases are still reported annually through global adverse event reporting systems.” according to Octapharma USA President Flemming Nielsen.
The FDA press release is below and for more information, follow the links after the press release.
FDA approves Octaplas to treat patients with blood clotting disorders
The U.S. Food and Drug Administration today approved Octaplas, a pooled plasma (human) blood product for the replacement of clotting proteins (coagulation factors) in certain medical conditions where patients have insufficient levels. Clotting protein deficiencies can cause excessive bleeding or excessive clotting.
Octaplas is a sterile, frozen solution of pooled human plasma from several donors that has been treated with a solvent detergent process. This process kills certain viruses and thereby minimizes the risk of serious virus transmission. The plasma used to manufacture Octaplas is collected from U.S. donors who have been screened and tested for diseases transmitted by blood, and determined to be suitable donors.
“For patients suffering with clotting disorders, this product provides a viable alternative to single-donor Fresh-Frozen Plasma and provides a reduced risk of certain viral transmissions,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research.
Like Fresh Frozen Plasma, Octaplas should be matched to the recipient’s blood group to help avoid transfusion reactions. An additional benefit to Octaplas is that each lot is tested for composition of key clotting factors and is only released if the levels are within acceptable ranges.
Octaplas has been used extensively in Europe and other countries. A previous generation of Octaplas was first marketed in 1992, and the current version has been marketed since 2009. All generations of the product have had similar manufacturing processes and comparable ingredients and properties. In total, more than 2 million patients have been treated with over 7 million doses of Octaplas outside of the United States.
The licensing of Octaplas was primarily based on clinical studies conducted in patients with liver disease, liver transplant, heart surgery and TTP. Additional data supporting the safe use of Octaplas for the U.S. market came from prior use of the products in Europe and other approved markets. Use of the product in Europe was not associated with transfusion-related acute lung injury, an uncommon but serious risk of transfusion with single units of plasma.
The most common adverse reactions observed in clinical studies included shortness of breath, dizziness, chest discomfort, skin itchiness and rashes, headache and tingling sensations.
The product is manufactured by Octapharma, Vienna, Austria.
For Immediate Release: Jan. 17, 2013
Media Inquiries: Rita Chappelle, 301-796-4672, firstname.lastname@example.orgConsumer Inquiries: 888-INFO-FDA, OCOD@fda.hhs.gov
Monday, January 21, 2013
The procedure can be repeated when the benefits of the previous treatment begin to decrease but an interval of at least 12 weeks should lapse between each treatment.
Following is the press release by FDA;
The U.S. Food and Drug Administration today expanded the approved use of Botox (onabotulinumtoxinA) to treat adults with overactive bladder who cannot use or do not adequately respond to a class of medications known as anticholinergics.
Overactive bladder is a condition in which the bladder squeezes too often or squeezes without warning. Symptoms include leaking urine (urinary incontinence), feeling the sudden and urgent need to urinate, and frequent urination.
When Botox is injected into the bladder muscle, it causes the bladder to relax, increasing the bladder’s storage capacity and reducing episodes of urinary incontinence. Injecting the bladder with Botox is performed using cystoscopy, a procedure that allows a doctor to visualize the interior of the bladder while Botox is being injected.
“Clinical studies have demonstrated Botox’s ability to significantly reduce the frequency of urinary incontinence,” said Hylton V. Joffe, M.D., director of the Division of Reproductive and Urologic Products in FDA’s Center for Drug Evaluation and Research. “Today’s approval provides an important additional treatment option for patients with overactive bladder, a condition that affects an estimated 33 million men and women in the United States.”
Botox’s safety and effectiveness for this new indication were established in two clinical trials of 1,105 patients with symptoms of overactive bladder. Patients were randomly assigned to receive injections of 100 units of Botox (20 injections of 5 units each) or placebo.
Results after 12 weeks showed that patients treated with Botox experienced urinary incontinence an average of 1.6 to 1.9 times less per day than patients treated with placebo. Botox-treated patients also needed to urinate on average 1.0 to 1.7 times less per day and expelled an average of about 30 milliliters more urine than those treated with placebo.
Treatment with Botox can be repeated when the benefits from the previous treatment have decreased, but there should be at least 12 weeks between treatments.
Common side effects reported during clinical trials included urinary tract infections, painful urination, and incomplete emptying of the bladder (urinary retention). Patients who develop urinary retention may need to use a catheter until the urinary retention resolves. Patients being treated for overactive bladder with Botox should not have a urinary tract infection and should take antibiotics before, during, and for a few days after Botox treatment to lower the chance of developing an infection from the procedure.
Botox is manufactured by Allergan Inc. based in Irvine, Calif.
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FDA Approved Drugs: Questions and Answers