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Advisory Panel at FDA Gives Backing for New Diabetes Drug

 The drug could be the first of a new class of medications in the U.S. to treat diabetes

The drug could be the first of a new class of medications in the U.S. to treat diabetes

January 14, 2013 – On Thursday, an advisory panel voted to approve a new diabetes drug, by a vote of 10 to 5. The drug could be the first of a new class of medications in the U.S. to treat diabetes. However, several members raised questions and concerns over the potential risks using it in patients with impaired kidneys and the medication’s cardiovascular risks.

Johnson & Johnson is developing the drug known as canagliflozin. It is one of a new group of medication that lowers the level of blood sugar by causing the sugar to be excreted through the urine. A number of existing treatments work by affecting the use or supply of insulin.

J&J had clinical trials of over 10,000 patients across the globe that showed the drug improved the levels of blood sugar in the participants and led to blood pressure reduction and weight loss. The medication is a once a day treatment for adults who have type 2 diabetes. An estimated 26 million people, in the U.S., are affected by the disease.

Even members of the panel who voted for the approval voiced concerns over the potential side effects and urged Johnson & Johnson to monitor its patients closely who are taking part in safety studies that are long term. Some doctors said they thought the drug should not be given to people with moderate kidney disease.

Recent studies of this group showed the drug was not as effective as it was for those whose kidneys were functioning normally, even though the group with moderate kidney disease was at a higher risk of the negative side effects. Doctors said the new medication is not recommended for use in patients that have severe kidney disease.

Doctors also mentioned concerns such as signs of a higher risk of stroke and a smaller increase in the risk of heart attack, as well as other problems cardiovascular related in the first 30 days the medicine is prescribed. Bad cholesterol (LDL) levels were shown to increase as well, although the good cholesterol (HDL) levels increased as well.

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