Recently the advisory committee of FDA (Food and Drug Administration) had 50-50 opinion on whether to approve oral medication manufactured by Lexicon Pharmaceuticals Inc and France’s Sanofi for the treatment of type 1 diabetes.
Sanofi and Lexicon Pharmaceutical have named the drug Sotagliflozin. They planned to sell it under the name of Zynquista. In the panel discussion on 24 January 2019, the researcher voted 8-8 when asked to start the insulin therapy along with a daily dose of Sotagliflozin.
For decades Insulin has been used for the treatment of diabetes that often leads to side effects such as weight gain, and hypoglycemia. Hypoglycemia is a condition in which a patient suffers from a sudden fall in blood sugar to the dangerously low level.
According to the statement given by Pablo Lapuerta, chief medical officer at Lexicon, “Sotagliflozin, which was tested in two doses, could help manage and maintain glucose levels while reducing the risk of hypoglycemia”.
This medication was tested on those patients who were the part of trails to advocate the effectiveness of drugs. However, FDA claimed the risk of Ketoacidosis, which leave the expertise baffled to whether the treatments should be sanctioned or not.
Ketoacidose, aka DKA, is a life-threatening condition in which there is an excessive flow of acid released in the body, this acid is called ketones which consumes body fat instead of glucose as a source of energy.
Martha Nason, a panel member who voted against the action, says, “I was not convinced it was a reasonable tradeoff”
Patients who have undergone such treatment says it reduced the fluctuations in blood sugar levels and also helped them in weight loss.
The companies came up with the proposal that includes a risk evaluation and mitigation strategy (REMS). According to this strategy, patients and physicians are required to regularly test their ketone levels in order to keep a check.
According to Rebecca Brown, a panel member who voted for the approval, “the task going forward will be to have a REMS strategy that will effectively select and maintain the patients and providers who can use this drug in the safest way possible.”
In America, every year around 40,000 new cases of diabetes gets registered. While there about 1.25 million (12.5 lakhs) American suffering from type 1 diabetes.
There is no certainty whether FDA will approve Zynquista, the final verdict will be out by 22 March 2019. However, Sanofi has declined to comment on its market price of Zynquista if it gets approved.