FDA Approves Type-2 Diabetes Medication
In a January 8 press release, the FDA announced it had approved Farxiga. The tablet-form drug has been approved for use in adults suffering from type-2 diabetes which affects 24 million individuals and currently accounts for 90% of individuals with diabetes in the U.S. Patients diagnosed with diabetes are at risk for heart disease, kidney disease, amputations and eyesight loss.
Farxiga is a product of Bristol-Myers Squibb in collaboration with AstraZeneca. The two companies joined forces in December of 2013 with the united idea of producing revolutionary treatment options for diabetes and other metabolic disorders related to diabetes. Both companies are seeking to develop medications that are not only meant to control glucose levels in patients but offer a wide range of relief from them.
According to the Farxiga drug facts, the most serious of its side effects include both male and female yeast infections and dehydration. The drug may cause an increased chance of dehydration in patients who have low blood pressure and those who are over the age of 65. Individuals on a low sodium diet are also at risk of dehydration if using Farxiga as well as patients with kidney disease and those taking diuretics and hypertension medication.
Ten cases of bladder cancer were found in patients taking the drug during clinical trials. However, in studies on individuals taking Farxiga and patients taking other diabetes medications, bladder cancer occurred less in Farxiga patients. To better understand whether or not bladder cancer is a true side effect of Farxiga, the FDA is requiring BMS and AstraZeneca to track rates of bladder cancer in patients enrolled in a long-term follow up study.
The alliance was met with the condition that AstraZeneca acquired all of BMS’s interest in the companies’ diabetes-induced business relationship. The intention of the acquisition is meant to compact the global ownerships of the diabetes enterprise within AstraZeneca. While the deal between both companies is not set to be finalized until the first quarter of 2014, Farxiga is the first treatment approved by the FDA for these two companies since the merger.