Amylin Pharmaceuticals has won US Food and Drug Administration approval for its lead diabetes drug, Symlin (pramlintide), for use together with insulin to treat both type 1 and type 2 diabetes patients who cannot adequately control their blood sugar level with insulin alone. Amylin’s share price rose by more than 12% during trading on the Nasdaq Stock Exchange yesterday on the news.
Symlin – a synthetic version of the naturally-occurring hormone, amylin, which is made by the same cells that produce insulin – is the first agent since insulin was discovered 80 years ago with the potential to help type 1 diabetes patients improve glucose control without any weight gain. It will be commercially available in around 90 days. However, the drug’s label will carry a boxed warning to highlight an increased risk of severe hypoglycaemia, or dangerously low blood sugar – one of the most common side effects of diabetes treatment, which can lead to fits, loss of consciousness, coma or even death – particularly amongst type 1 diabetes patients.
It has been a long route to market for Symlin. An FDA advisory panel voted not to approve the product back in 2001 over safety concerns [[30/07/01e]]. However, an approvable letter was issued later this year, but said that final approval would be contingent on additional clinical trials being conducted [[15/10/01d]]. A second approvable letter followed late in 2003 after the company re-submitted Symlin to the US regulator, but this again asked for additional clinical information.