FDA Approves J and J New Class of Drug for Diabetes 2, Expelling Sugar Via Urination
Posted Mar 30 2013 1:04am
Some MDs are cautious with the results and use so far as the drug is basically using a “side effect” as a treatment. I wrote this up a few months ago on how it differs from current products on the market. It’s not cheap though as anything new goes for more money and at almost $9 a tablet, it will be interesting to see how it sells.
It has some other added benefits like reduction in weight and some reductions in blood pressure but there are side effects too such as elevated risk of stroke and raising LDS, the bad cholesterol levels. J and J will need to conduct post marketing studies to iron out more of the side effect risks along with a clinical trial. The drug is not for use for patients that have kidney disease. BD
The U.S. Food and Drug Administration approved the drug, Invokana, after data showed it was effective in lowering blood sugar in patients with Type 2 diabetes, the most common form of the disease.
The FDA has asked for five post marketing studies for the drug including a cardiovascular outcomes trial, an enhanced pharmacovigilance program, a bone safety study and two pediatric studies, the agency said in a statement on its website.
In January, 2012, the FDA rejected a similar drug, dapagliflozin, made by Bristol-Myers Squibb Co and AstraZeneca Plc, citing concerns over a possible increased risk of cancer and liver injury. The drug was subsequently approved in Europe under the brand name Forxiga.