FDA approves product to treat common bleeding disorder

The U.S. Food and Drug Administration (FDA) today approved Humate-P (Antihemophilic Factor/von Willebrand Factor Complex) for the prevention of excessive bleeding during and after surgery in certain patients with mild to moderate and severe von Willebrand disease (vWD). The disease is the most common inherited bleeding disorder, affecting about 1 percent of the U.S. population.

Humate-P is the second biological product to be approved for the management of surgery and invasive procedures in patients with vWD in whom the medication desmopressin may not work. The first biological product, Aphanate, was approved by FDA in February. However, Humate-P is the first product specifically for patients with severe vWD who are undergoing major surgery.

"This is an important advance for patients with vWD, including those who are severely affected by the disorder," said Jesse Goodman, M.D., M.P.H., director of FDA’s Center for Biologics Evaluation and Research. “Humate-P provides a preventive therapy that can make needed surgery not only possible, but also safer."

The product was originally approved for use in adult patients to treat and prevent bleeding from hemophilia A. It was later approved to treat spontaneous and traumatic bleeding for severe vWD and for mild and moderate vWD when desmopressin use is known or suspected to be inadequate.

Humate-P is made by purification of the needed clotting protein from human plasma from carefully screened and tested U.S. donors. It undergoes steps to further reduce the risk for transfusion-transmitted diseases. While the risk for the transmission of bloodborne diseases is very low, it can not be eliminated.

FDA based its approval on a clinical study of Humate-P in 35 patients suffering from vWD who underwent a total of 28 major and seven minor surgical procedures. The product was judged excellent or good in 91 percent of the patients who avoided severe hemorrhage. The most common adverse reaction following surgery was hemorrhage, in 30 percent of the patients; however, only 9 percent of the hemorrhages were classified as severe.

Other adverse reactions in patients following surgery included nausea (24 percent) and pain (17 percent).

Men and women are equally affected by vWD, which is caused by a deficiency or defect in certain plasma proteins critical to blood clotting. In most cases, the disease is mild, and treatment usually is not required to stop bleeding. However, about 2,000 people in the United States each year suffer from moderate and severe forms of the disease in which bleeding can be excessive if not treated and possibly cause delayed wound healing.

Humate-P is manufactured by CSL Behring GmbH, Marburg, Germany.

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Heparin better at preventing clots after stroke

A newly engineered form of the blood-thinning drug heparin has proven more effective at preventing life-threatening clots in people who suffer strokes than the older version of the drug, a new study finds.

The incidence of clots in the lungs and legs of stroke patients who got the engineered form, called enoxaparin, was 43 percent lower than in those who got ordinary heparin, researchers said.

"This is the first big trial in which the two treatments have gone head to head," said lead researcher Dr. David G. Sherman, a professor of medicine and neurology at the University of Texas Health Science Center, in San Antonio. "Enoxaparin pretty convincingly appears to work better."

"Now that the results have been published, the question is, what will the bodies that write guidelines for management of stroke do?" Sherman added. "Because the results are so consistent, my guess is that the guidelines will say that stroke patients should be anticoagulated and that, because enoxaparin appears to be most efficient, it will become the standard."

The trial was funded by Sanofi Aventis, the maker of enoxaparin (Lovenox).

The finding, reported in the April 21 issue of The Lancet, is potentially applicable to more than 700,000 people who suffer strokes in the United States each year, Sherman said. These patients are at high risk of clotting because of their forced inactivity. In fact, the 1,762 stroke patients in the study received anticoagulant treatment only if they were unable to walk.
Half of the patients were given one injection of enoxaparin a day, the other half received two daily injections of heparin. They were then studied for the presence of blood clots in the legs and lungs.

The study included only patients who suffered ischemic stroke, the most common kind. In this type of attack a blood clot blocks a brain artery. However, Sherman said there are indications that the results also apply to people who have hemorrhagic strokes, in which a blood vessel bursts.

Cost remains a potential issue, however, because enoxaparin is much more expensive than ordinary heparin. Sherman's group is working on an analysis determining the economic impact of a shift to using enoxaparin on the total cost of treating stroke.

One prior study has indicated that introducing the drug might actually lead to cost reductions, said Dr. Richard M. Weinberg, chief quality officer of the Stamford Health System in Connecticut. His team tracked costs across 33 hospitals.

"On average, there is a big cost difference between the two: $1-a-day for heparin, $25 a day for Lovenox," he said. However, "over six years, when we looked at all the adult discharges and made adjustments for [illness] severity and risk, overall it was cheaper to treat with Lovenox."

There are several possible explanations for the lower overall cost, Weinberg said. "Most patients getting Lovenox can be managed without the frequent tests needed for heparin," he said. "In addition to reduced laboratory testing, a reduction in the length of stay and less time spent in the ICU [intensive care unit] are possible explanations."

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Experimental cancer drug may not affect heart

Kosan Biosciences Inc. said new safety data from preclinical and early-stage clinical trials of tanespimycin show that the experimental cancer drug does not affect heart rhythms.

The drug is designed to block a protein that cancer cells need to proliferate and grow.

Kosan said on Sunday electrocardiogram monitoring of patients was conducted in four phase I trials of tanespimycin and the results for 85 patients have been analyzed.

Tanespimycin was found to have no effect on QTc interval - the time it takes the heart to electrically recharge itself -- based on analyses of the results by outside cardiologists, the company said.

Chief Executive Robert Johnson said the analyses show that two previously reported incidents of possible QTc interval effects in studies conducted by the National Cancer Institute were due to misreading of automated computer printouts.

Kosan said the drug has so far been tested in more than 600 patients and it plans to launch in the first half of this year a phase III trial of tanespimycin in patients with multiple myeloma.

Johnson said the company is currently talking to potential partners about co-development of the drug.

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Flu vaccine grown in insect cells

Scientists have made an experimental - and apparently effective - flu vaccine inside insect cells.

They hope the technique could provide a way to produce vaccine quickly and in volume in the event of a flu pandemic.

At present flu vaccine is produced in hens' eggs, but this is time-consuming, and each egg can only produce one dose of vaccine.

The University of Rochester study appears in the Journal of the American Medical Association.
Scientists believe it is inevitable that the world will face a flu pandemic in the future.

Rapid development, production and distribution of a vaccine will be key to saving lives.
Researcher Professor John Treanor said: "Eggs can be very cumbersome to work with.

"When you need hundreds of millions of fertilized eggs, you're dealing with a whole host of agricultural issues, as well as scientific concerns regarding the flu virus itself.

"Flu viruses can be temperamental, and it's not always an easy matter to get the virus to grow as you want in eggs."

The researchers tested a vaccine called FluBIOk, which relies on a virus which normally infects insects known as baculovirus to churn out its key components.

Promising trials

Tests on 460 volunteers showed nobody who received a 135 microgram dose of the vaccine went on to develop the three strains of flu thought to pose the biggest threat when the study was conducted in the winter of 2004-2005.

The researchers estimate that using insect cells rather than eggs to manufacture the vaccine could slice up to two months off a process that at present takes about six months to produce enough supplies to protect the US public.

They also argue that not relying on chicken eggs might also be advisable in case a bird flu pandemic hits chicken flocks hard.

In addition, a live flu virus is needed when growing vaccine in eggs, a danger when working with a potent bird-flu strain.

Another potential advantage of FluBIOk is that, unlike other flu vaccines, it does not contain neuraminidase, an enzyme that allows a flu virus to replicate and spread.

Professor John Oxford, an expert in virology at London's Queen Mary College School of Medicine, said other researchers were exploring similar techniques for producing flu vaccines.

He said two groups had used mammalian cells, while another was experimenting with the use of plants.

"Using eggs has been very successful for the last 40 years," he said.
"But if you need to increase supplies quickly in the wake of a pandemic you just can't do that using eggs."

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Biologic drug approved to prevent hepatitis B in liver recipients

HepaGam B, a first-of-its-kind immune globulin product, has been approved by the U.S. Food and Drug Administration to prevent hepatitis B reinfection among people who have received liver transplants, the agency said Friday.

Immune-compromised liver transplant recipients who have already been exposed to hepatitis B are at increased risk of re-infection from the virus, which attacks the liver and can cause liver failure or liver cancer. HepaGam B, produced from human plasma, stimulates an immune response to the virus, the FDA said.

The product reduced the infection recurrence rate to about 13 percent from 86 percent among liver transplant recipients who participated in clinical trials, the agency said. Common adverse reactions included headache and high blood pressure.

HepaGam B was first FDA-approved in January 2006 to prevent hepatitis B infection acquired by sexual or contact exposure, and in unborn infants whose mothers had been exposed to the virus. The product is manufactured by Cangene Corp. of Winnipeg, Canada.

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Two medications treat migraine better than one

Combining two commonly used medications can provide faster, long-lasting relief of migraine pain than using either drug alone, concludes a new study.

The study compared the use of a new combination pill that includes sumatriptan (brand name Imitrex) and naproxen sodium (Aleve) to use of either drug alone and to a placebo for moderate to severe migraines.

The researchers found that the combination therapy provided headache relief within two hours for as many as 65 percent of the study volunteers compared to about 28 percent for placebo. Up to 55 percent reported that Imitrex alone provided relief, while as many as 44 percent felt that naproxen gave them relief from their headache.

"The combination product is superior to the individual products alone," explained study author, Dr. Jan Lewis Brandes, a neurologist with the Nashville Neuroscience Group and an assistant clinical professor of neurology at Vanderbilt University School of Medicine in Nashville, Tenn. "It really targets more of what's happening in the brain during migraine. Sumatriptan works to constrict the blood vessels and interrupt pain, while naproxen works on the inflammatory process."

Results of the study are in the April 4 issue of the Journal of the American Medical Association.
Funding was provided by pharmaceutical manufacturers Pozen and Glaxo SmithKline.
While both medications included in the combination pill have already received government approval, the new combination must also be approved by the U.S. Food and Drug Administration. Lewis Brandes said the FDA is reviewing data on the medication and may make a decision by August 2007. If approved, the combination will likely be sold under the brand name Trexima.

Almost 30 million Americans suffer from migraines, according to the National Headache Foundation. Migraines may cause headache pain -- often just on one side of the head, visual disturbances, sensitivity to light, and nausea and vomiting. Migraines may last hours or even days.
While the introduction of medications known as triptans -- including sumatriptan -- has improved migraine management, some people still don't get relief, according to background information in the article.

And, according to Lewis Brandes, and another headache expert, Dr. Wade Cooper, director of the St. John's Health Chronic Headache and Migraine Institute in Madison Heights, Mich., many headache experts already recommend a combination of medications to combat migraine pain.
The current study included almost 3,000 people between 18 and 65 who suffer from migraines. The study participants, who were recruited at 118 clinics across the United States, were randomly assigned to one of four groups: the combination therapy (a single pill containing 85 milligrams sumatriptan and 500 milligrams naproxen sodium); 500 milligrams naproxen sodium (Aleve) alone; 85 milligrams sumatriptan (Imitrex) alone; or a placebo. They were told to take the medication when their migraine pain was moderate to severe in intensity.

More people reported short-term relief from headache pain and lessened sensitivity to lights and sounds on the combination therapy than on either drug alone or for the placebo. At 24 hours, results were similar, with more people on the combination therapy reporting sustained headache relief -- as many as 48 percent -- versus up to 35 percent on sumatriptan, 30 percent on naproxen sodium and 18 percent on placebo.

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