When Danish drug major Novo Nordisk launches its ultra long-acting insulin molecule Tresiba next week,diabetologists will fete it as the next big thing in diabetes care liberating insulin users from injections at fixed times. It is being touted as a product that will minimise hypoglycemia (low blood sugar).
For Indian drug regulators,what may be of greater import is that Tresiba has been put on hold in the US on concerns about cardiovascular safety. The USFDA in February asked the company to return more data on cardiovascular risk profile of insulin degludec and insulin degludec/aspart (chemical names of Tresiba).
On April 27,2012,the agency asked Novo Nordisk to update original analysis with data from ongoing Phase 3 trials. An updated analysis was received. In the analysis containing additional follow-up data degludec,products were estimated to confer a 30% increased risk of cardiovascular death,non-fatal MI,non-fatal stroke and unstable angina…, reads the FDA document. FDA is stringent in CV risk of drugs targeted at diabetes. It has been approved for import here. Though USFDA has asked for more data on CV safety,the drug is already in use in EU,UK and Japan, said a senior health ministry official.
Drug regulatory systems in US and India are different. Besides,there is nothing new in the molecule… stays active for more than 40 hours as opposed to the maximum 24 hours for drugs in the market. The primary advantage is flexibility…and lower episodes of hypoglycemia, said Dr S K Wangnoo,senior endocrinologist,Indraprastha Apollo Hospitals,who will speak about Tresiba at its launch.