Aventis’ Apidra approved in US
pharmafile | April 26, 2004 | News story | |
The FDA has approved Aventis' rapid-acting insulin analogue Apidra, ahead of an anticipated August approval by the EMEA, as the company continues to expand its diabetes portfolio. Apidra (insulin glulisine) was submitted to the US regulators in June 2003 and was approved for the treatment of adult patients with diabetes mellitus for the control of hyperglycaemia.
The treatment is a recombinant DNA insulin analogue and has a more rapid onset and a shorter duration of action than human insulin and is designed to cover mealtime 'spikes' in blood sugar levels. Aventis says the drug would be particularly effective in combination with Lantus (insulin glargine) the long-acting insulin which smoothes out blood sugar levels over a 24-hour period.
Launched in the US three years ago, and in the UK in 2002, Lantus is already well established and the company hopes it will become its flagship insulin brand. Frank Douglas, executive vice president for Drug Innovation and Approval at Aventis welcomed the FDA approval of Apidra saying: "Aventis is now able to offer a full spectrum of diabetes treatment options for optimal management of blood glucose control in diabetes." A company spokesperson said a European opinion on the product from the EMEA advisory committee the CPMP was expected in May and, assuming this is a positive one, final clearance could happen in August.
The US approval for the product will strengthen Aventis' existing diabetic franchise, which includes Amaryl which earned E596 million and Aventis' Insuman family of insulins, which generated sales of E176 million last year.
The company has a number of other treatments for diabetes in various stages of development. Most promising of all is the breakthrough inhaled insulin product Exubera, which was submitted to the EMEA in early 2004 and is being developed in partnership with Pfizer.
Another compound, DiaPep277 is in phase I/II clinical trials for the treatment of type I diabetes.
