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FDA Recommends More Study of Diabetes Drug
A recent article in The Boston Globe announced that a federal panel of experts is recommending long-term studies of a diabetes drug from Bristol-Myers Squibb be conducted before it is approved by the Federal Food and Drug Administration for use.
The article, describes a federal panel investigating the drug Onglyza that is made by Bristol-Myers and partner AstraZeneca used to treat people with Type 2 diabetes. A panel of diabetes experts is investigating diabetes drugs. The FDA recently issued new safety guidelines for diabetes treatments and this panel is investigating each of the drugs used. In 2007 there were concerns about the drug Avandia made by GlaxoSmithKline that may have heightened the risk of heart attacks.
The panel voted that although the drug Onglyza does not appear to hasten heart attacks, strokes, or other problems, it recommended that there be a long-term study in high risk patients before they approve the drug for use. Those kind of large long-term studies can be expensive and take years to complete.
Type 2 diabetes affects about 23 million adults and teenagers. People with the disease have trouble breaking down carbohydrates, because their bodies have become resistant to the protein insulin. They have a higher risk of developing heart attacks, kidney problems, blindness and other complications.
The panel of experts recommends their decisions to the FDA, who then makes a final decision about whether to follow the panel’s recommendations. That FDA decision is expected by April 30th. The two votes illustrate the government’s concerns for testing these diabetes drugs on people with heart conditions. A requirement for long-term safety studies could significantly drive up research costs for dozens of companies working on treatments to compete in the $5 billion U.S. diabetes drug market.
According to The Washington Times, Bristol-Myers and partner AstraZeneca conducted their studies of Onglyza before the FDA issued its guidelines on heart safety in December. As a result, they tested the drug on relatively healthy diabetes patients, instead of those with elevated heart risks, as the FDA now recommends.
The drugmakers said in a joint statement they will “continue to work closely with the FDA to support the review of Onglyza." The same panel is also reviewing a drug from Novo Nordisk, one of the companies seeking a treatment for type 2 diabetes,
Bristol-Myers and London-based AstraZeneca want to compete with another drug company Merck that produces Januvia, a similar drug that had sales of $1.4 billion last year.
Consumer Reports has put together a two-page guide in the form of a downloadable pdf format, that looks at current and new drugs available for Type 2 diabetes. According to this guide, Consumer Reports recommends the following: Two drugs from a class called the sulfony- lureas and a drug named metformin have been around for more than a decade and work just as well as newer medicines. They feel that several of the newer drugs are less effective than the older ones. They claim that newer drugs are no safer and at the same time are more expensive.
