There is new hope of succour for women suffering from pregnancy diabetes with the European Commission (EC) approving the use of insulin drug ”NovolRapid,” as the first modern insulin that has a label stating can be used in pregnancy.
Thanks to an exhaustive study conducted by Novo Nordisk, proving the safety and efficacy of the drug, the European Commission has given its nod for its use by pregnant women with diabetes, Dr Anil Shinde, Medical Director, Novo Nordisk India Private Limited said.
He said the company had conducted the study, involving 322 pregnant women with type I diabetes spread over in 70 countries in 90 different hospitals over the last four years.
The Regulatory Commission of EU gave its approval in July after it was established that NovoRapid significantly improved first and third trimsters postprandial glycaemic control as compared to human insulin, he said.
After the Drug Controller General of India (DGCI) gave its approval, the drug was available in the market for the last three years as an insulin drug for generally affected diabetes.
However, now with the onset of the landmark study and its approval from the Erupean Commission, the drug is recommended for women suffering from pregnancy related diabetes, he said.
Citing a World Health Organisation (WHO) study, Dr Shinde said prevelance of Gestational Diabetes Mellitus (GDM-defined as any degree of glucose intolerence during pregnancy) in Indian women was nearly 17 per cent and is growing.
He said there would be 80 million women in reproductive age with diabetes in the world, including 20 million in India, in the next two to three decades.