New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has rejected Danish pharma giant Novo Nordisk’s application to import and sell a treatment touted as the world’s first weekly insulin, ThePrint has learnt.
The drug regulator has asked the pharmaceutical giant for more details about the drug, which is not yet approved anywhere, including the country of origin.
The subject expert committee (SEC-Endocrinology & Metabolism) under the CDSCO reviewed the application for Icodec on 11 January. The committee noted that the firm did not specify the indication for the drug, based on the data from global clinical studies. ThePrint has a copy of the SEC meeting minutes.
“After detailed deliberation, the committee recommended that the firm should present specific indications based on the data generated from global clinical studies along with the approval status of the proposed product in the country of origin for further review by the committee,” the SEC said.
The CDSCO decision on Icodec comes days after the Organisation of Pharmaceutical Producers of India (OPPI) — a group of multinational pharma companies — wrote to the CDSCO for faster approvals by granting parallel market authorisation that will allow drugs and innovative therapies to be marketed in India at the same time as in the US and Europe.
Icodec has been touted as a therapy that could eliminate the need for daily or mealtime insulin injections for people with severe diabetes. It is seen as a potential gamechanger for millions of diabetics who need insulin therapy.
Currently, many diabetics have to take daily insulin injections, and some need multiple shots per day.
India is often referred to as the “diabetes capital of the world”.
According to a study carried out by the Indian Council and Medical Research (ICMR) and Madras Diabetes Research Foundation, and published in The Lancet last year, India has nearly 101 million diabetics. An estimated 30 percent or more people with type-2 diabetes require insulin therapy.
Insulin Icodec is also waiting for regulatory approval by the US Food and Drug Administration.
ThePrint reached Rajeev Singh Raghuvanshi, the Drug Controller General of India, who also heads the CDSCO, for comments via call, but failed to get a response. An email query to Novo Nordisk also remained unanswered. This report will be updated if and when a response is received.
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‘No significant safety concerns’
In its proposal to the CDSCO, Novo Nordisk had sought permission for importing and marketing Icodec 700 U/ml, 1,050 U/1.5 ml and 2,100 U/3ml solutions in prefilled pens for the treatment of diabetes mellitus or type-2 diabetes in adults.
The application was based on the global clinical trials ONWARDS 1 to 6, which included 102 Indian patients.
The final results of the 52-week phase-3 clinical trials for Icodec, conducted across 80 sites in nine countries, including India, to test its safety and efficacy, were published in The Lancet last year.
The results showed that people with long-standing type-2 diabetes on a basal-bolus regimen (multiple injections a day) had similar improvements in blood sugar control with a once-a-week dose of Icodec, better than once-a-day insulin.
In addition, they also suggested no significant safety concerns with the drug.
Meanwhile, in an interview with ThePrint, Vikrant Shrotriya, corporate vice-president and India managing director of Novo Nordisk, said the firm was looking to launch Icodec in India by 2025.
(Edited by Richa Mishra)
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