An advisory panel working for US Food and Drug Administration split evenly on the decision to whether to approve a first of its kind oral medication for treating Type 1 diabetes. The committee is undecided about the approval with a vote 8-8 and has left the decision to the agency by the end of March 2019.
The drug sotagliflozin made by drug makers Lexicon and Sanofi Pharmaceuticals is planned to be sold under the brand name Zynquista. The medication which is to be taken along with insulin came under increased scrutiny owing to certain severe side effects of the medicine. The drug poses a higher risk to patients in developing diabetic ketoacidosis. Diabetic ketoacidosis (DKA) is a condition where the body doesn’t produce enough insulin leading to high blood sugar and highly acidic substances called ketones. It’s a serious life-threatening complication for Type 1 diabetic patients. The risk of developing DKA has led many reviewers to vote against the drugs release.
In Type 1 diabetes the body doesn’t produce insulin, so people with the condition have to regularly monitor their blood sugar levels from rising beyond a certain limit. Type 1 Diabetes often called juvenile diabetes is usually diagnosed early in childhood. People with the condition are treated with insulin but it often leads to fluctuation in blood sugar levels causing much discomfort. The proposed Zynquista drug is a one-time daily drug which helps manage the patient’s blood sugar level, however it reduces the blood sugar levels by excreting excess sugar into urine.
The drugs approval process was based on three clinical trials which involved around three thousand patients. The results found that there were about 56 cases of patients developing DKA among 1,748 patients, or 3.2 percent while the placebo test showed that 5 patients developed DKA among 1,229 patients or 0.4 percent. The drug trials brought significant benefits to the patient including reduced blood sugar, some weight loss and lowered blood pressure.
The panel members were aware of the risk involved in DKA which has often led to serious hospitalization and death and raised concerns about the higher risk involved in real world adoption of the drugs outside the confines a clinical trial. A panel member who voted against the drug, Dr. Jack Yanovski said that the smaller degree of benefits may not outweigh the increased risk it may pose to the patient. Other panel members disagreed by stating that the patients are in desperate need of the Zenquista drug.
There are about 1.25 million people in USA suffering from Type 1 diabetes and 40,000 are diagnosed every year, according American Diabetes Association. The companies said that they would continue to work towards approval of the drug with USFDA.