The Race to Replace Warfarin

The company’s experimental anticoagulant drug apixaban worked better than aspirin in preventing stroke and systemic blood clots for patients who have a heart rhythm disorder called atrial fibrillation, according to new study data presented on Tuesday morning at a cardiology conference in Stockholm.

Investment bank analysts have estimated that a new category of stroke prevention drugs like apixaban, if approved by the Food and Drug Administration, could generate $10 billion or more in annual global sales. (See related article.)

Patients taking apixaban had a rate of stroke or systemic blood clots of 1.7 percent per year while those on aspirin had a rate of 3.9 per year, according to an interim analysis of the new data. The rate of major hemorrhage was 1.6 percent per year for the apixaban group and 1.4 percent on aspirin, researchers reported.

Atrial fibrillation affects about 2.2 million people in the United States, and that number is expected to double in the next 10 years, according to the National Heart, Lung and Blood Institute.

Bristol-Myers discovered apixaban and is developing the drug jointly with Pfizer. The study involved 5,600 patients who were unsuited for the standard treatment for atrial fibrillation, warfarin.

In a note to investors on Tuesday morning, Chris Schott, an analyst at J.P. Morgan, wrote that positive responses to the study data among leading cardiologists “suggest that apixaban will likely capture a disproportionate share,” by some estimates up to 50 percent, of warfarin-intolerant patients.

The companies are also conducting a head-to-head trial of apixaban and warfarin in more than 18,000 patients with atrial fibrillation. The companies expect to report data from that study next year, a spokeswoman for Bristol-Myers Squibb said.

Indeed, apixaban is one of several drugs that pharmaceutical companies are developing in an effort to replace warfarin, a decades-old drug for atrial fibrillation that is effective but comes with drawbacks. Prescription drugs like antibiotics, as well as foods rich in vitamin K, can affect the effectiveness of warfarin. Also, patients on warfarin need regular tests to evaluate their blood clotting rate.

Other warfarin alternatives in the pharmaceutical pipeline include rivaroxaban, originally discovered by Bayer Healthcare and now under development jointly with Johnson & Johnson and dabigatran from Boeheringer Ingelheim.

According to a new study presented Tuesday at the cardiology conference in Stockholm, rivaroxaban worked about as well as standard treatments at preventing recurrent blood clots in the veins for people with deep vein thrombosis. The rate of risky blood clots in the veins or lungs was 2.1 percent for the rivaroxaban group and 3 percent for the standard treatment group, according to a press statement Tuesday from Johnson & Johnson. The rate of bleeding, a side effect, was about 8 percent in each group, the release said.

Johnson & Johnson has submitted an application to the Food and Drug Administration for rivaroxaban as a treatment to reduce the risk of dangerous blood clots in people undergoing knee or hip replacement surgery. Rivaroxaban is already marketed for that purpose in 75 countries outside of the United States, including Canada.

Meanwhile, Boehringer Ingelheim, the German drug maker has developed dabigatran, a drug to prevent stroke and systemic blood clots in patients with atrial fibrillation. The drug is already approved for use in Canada. An F.D.A. panel is scheduled to review the drug on September 20th.

The share price of Bristol-Myers was up more than 1 percent, to $26.15 in morning trading.

MedWatch Safety Information Resources for Busy Physicians

http://www.youtube.com/watch?v=aBWth2KRvL0&feature=player_embedded

Women and Diabetes

Diabetes is a serious illness that affects over 20 million people in the United States. Anyone can have diabetes. Many people have diabetes but do not know it. Diabetes can cause serious health problems like heart disease, kidney problems, blindness, stroke, and loss of a foot or leg (amputation).

There is good news. You can control your diabetes. 

Diabetes can be controlled by maintaining a healthy diet, exercising, and using FDA-approved medicines, insulin, and devices every day. 

If you have diabetes, you should:

• Make a plan. Work with your doctor, nurse, or pharmacist
• Check your blood sugar regularly
• Watch what you eat. 
• Use medicines wisely. Consult your doctor.
• Be active and get exercise. 
• Know your ABC's:

    A stands for A-1-C blood test. It measures your blood sugar level over the last 3 months.

    B stands for Blood Pressure

    C stands for Cholesterol

HIV/AIDS Update - Tentative approval of generic atazanavir sulfate capsules, 300 mg

FDA granted tentative approval for generic atazanavir sulfate capsules, 300 mg, indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults. This generic formulation, manufactured by Emcure Pharmaceuticals Ltd. of Pune, India, was reviewed under the expedited review provisions of the President’s Emergency Plan for AIDS Relief (PEPFAR).

FDA's tentative approval means that although a product meets all of the safety, efficacy, and manufacturing quality standards required for marketing in the U.S., existing patents prevent marketing of the product in the United States. Tentative approval, however, does qualify the product for consideration for purchase under the President's Emergency Plan for AIDS Relief, or PEPFAR program.

This tentative approval is a generic formulation of Reyataz Capsules, 300 mg of Bristol Myers Squibb. Effective patent dates for this and all approved drugs can be found in the agency's publication titled Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the "Orange Book"

As with all generic applications, FDA conducts an on-site inspection of the manufacturing facilities and of the facilities performing the bioequivalence studies prior to granting approval or tentative approval to evaluate the ability of the manufacturer to produce a quality product and to assess the quality of the bioequivalence data supporting the application.

Pakistan's Flood Victims Face Outbreak of Diseases

Officials overseeing relief efforts in Pakistan say an outbreak of disease is presenting a new threat to flood victims as they brace for more rain.

Health officials Friday said the lack of clean drinking water and sanitation is spreading diarrhea and other diseases that could threaten lives.

An estimated 1,600 people have died from over two weeks of record flooding in the country brought on by heavy monsoon rains.  More storms are expected in the coming days across much of the country.

The United Nations has appealed for $460 million to provide immediate help, including food, shelter and clean water.

U.N. Secretary-General Ban Ki-moon is due to travel to Pakistan Saturday to discuss relief efforts. 

The U.S. State Department says Senate Foreign Relations Committee Chairman John Kerry will visit flood-stricken areas of Pakistan next week.

Insulin Tablets with better heat resistance

More than 200 Million people are victims of Diabetes in the world.
Insulin is the most commonly drug which is used against diabetes.The most common problems with the insulin are that it should be kept at cool place(4 Centigrade) and can only be administered by injection.

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But now,a chemist "Miss. Wynn Le-rope" with her fellows,has found the solution for both problems,according to which Insulin can be kept at room temperature and can also be administered in the form of tablet dosage form. 
Wynn Le-rope says,"I made a new chemical formula for insulin which can resist against heat up-to room temperature.(25 Centigrade) and soon it will also available in Tablet form." 
The present form of insulin need to keep at  4 Centigrade for long term use after which the chemical formula of insulin start to be changed and ultimately denatured.Due to this reason it is very difficult to handle the insulin for long term use. 
"I am also working on tablet dosage form of insulin and have succeeded in initial trials.In short period,diabetic patient will get relief from the pain of injection",she further said.

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