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Danish firm gets FDA approval for oral diabetes pill, no word yet on India launch

India has 7.2 crore people with diabetes and oral pills will help them avoid the pain of puncturing themselves again and again.

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New Delhi: The US Food and Drug Administration (FDA) has approved an oral version of Novo Nordisk’s diabetes drug semaglutide to control blood sugar in Type-2 patients.

If launched in India, the Danish firm’s drug can make a huge difference since there are more than 7.2 crore patients here and the numbers are only expected to swell to 13.4 crore by 2025.

The tablet, called Rybelsus, is the first glucagon-like peptide (GLP-1) receptor protein treatment that does not need to be injected. GLP-1 drugs are non-insulin treatments for people with Type-2 diabetes. It was first derived from a compound found in the saliva of the Gila monster, lizards that are native to the southwestern US.

Diabetes is a chronic disease in which the body fails to produce insulin, a hormone which controls blood sugar, or is unable to use it efficiently.

“Patients want effective treatment options for diabetes that are as minimally intrusive on their lives as possible, and the FDA welcomes the advancement of new therapeutic options…” said Lisa Yanoff, acting director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research, said in a statement.

Rybelsus works in a similar way as the semaglutide injection to improve and control blood sugar in adults with Type-2 diabetes, along with diet and exercise.

Also read: Why cheese may help control your blood sugar

Semaglutide unavailable in India 

Patients in India are treated by injectable drugs belonging to the same GLP-1 class of medication such as dulaglutide, sold by US drug maker Eli Lilly, and liraglutide sold by Novo Nordisk. But semaglutide isn’t available in the country yet.

“Rybelsus is an excellent drug since it takes care of other health parameters such as blood sugar, body and liver fat too which are particularly high in Type-2 diabetes,” said Dr Anoop Misra, chairman, Fortis-C-DOC Centre of Excellence for Diabetes.

Typically, after the approval of a drug by the FDA, its launch in the Indian market takes up to two to three years. ThePrint asked Novo Nordisk if it plans to make the pills available in India but the firm is yet to respond.

“Oral form of diabetes drugs would be of great use and help patients avoid the pain of puncturing themselves again and again,” added Misra.

‘Not first choice of medicine for treating diabetes’ 

The prescribing information for Rybelsus, however, includes a boxed warning for health care professionals and patients about the potential risks of “thyroid c-cell tumors”. It also states that Rybelsus should not be recommended as the first choice of medicine for treating diabetes.

FDA further warns about usage in conditions such as pancreatitis (inflammation of the pancreas), diabetic retinopathy (damage to the eye’s retina), hypoglycemia (low blood sugar), acute kidney injury and hypersensitivity reactions.

Also read: European regulator finds cancer-causing element in diabetes medicines made in India


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