The FDA approved the first diabetes drug to treat type 2 diabetes, with an effective dose of agavirin, on Tuesday.
The approval was the result of years of negotiations with the U.S. Food and Drug Administration (FDA), the drugmaker GavisCon Pharmaceuticals, and the manufacturer EGO Pharmaceuticals for the drug.
The drugmaker announced in April that it had secured approval for agavirine, a generic version of a protein drug, in the U, U.K. and Australia.
The FDA said in a statement that the drug had been approved for the treatment of diabetes because it has been shown to lower blood glucose levels, with “no additional risk to the health of the patient.”
“The FDA believes that it is safe, effective and cost-effective for Gavis Con to offer its agavirus vaccine to the U of A and other institutions in the United Kingdom and Australia,” the FDA said.
“The United Kingdom has successfully managed the introduction of its vaccine program in recent years, and EGO has made a significant investment in developing the Agavira vaccine for use in Australia.”
The U.s. has seen a sharp rise in the number of people with type 2 and type 1 diabetes, according to the CDC, and an estimated 12 million people are affected by both.
The disease, which afflicts one in four Americans, affects the body’s ability to use insulin, which helps to control blood sugar levels.
The agavira drug is based on a virus and contains a protein that targets a protein in the pancreas.
The protein, called the agavirenic acid (AA), is produced in the liver by the pancrea, and is responsible for the body absorbing insulin.
“Our first patient received a vaccine for type 2diabetes from the FDA, and we are now in the process of expanding our vaccines to include the next generation of agravirines to address the new pandemic, including the need for new vaccines for type 1 and type 2, as well as those who have type 1 or 2,” GavisCom reported.
The first drug for type two diabetes, called Agavisivir, was approved in March for use by about 1.4 million people.