FDA OKs Amylin Drug for Diabetes, Extenatide Not Far Behind

Symlin (pramlinitide) becomes the first new treatment in 80 years for patients with Type 1 of the disease. Expected approval for next Amylin drug Extenitide next month

Regulators approved Amylin Pharmaceuticals Inc.’s diabetes drug Symlin last Wednesday after an 18-year quest that investors had once written off as hopeless.

It was the first Food and Drug Administration endorsement for the small San Diego company, which was close to closing seven years ago after a clinical trial of Symlin went badly.

Symlin is a synthetic version of the natural hormone amylin, which works with insulin to control the flow of sugar from food into the bloodstream. It was approved for use by the estimated 4.5 million diabetics in the U.S. who use insulin to control their disease.

It will carry a boxed warning about the risk of hypoglycemia, or low blood sugar. Concern about low blood sugar was one reason why it took the FDA so long to approve the drug.

In fact, Symlin is the first new drug in 80 years for patients with Type 1 diabetes, which strikes in childhood. The drug also was approved for patients with Type 2 diabetes, which develops in adults.

Patients would take Symlin with insulin to control spikes in blood sugar. Regular insulin shots can control diabetes, but Symlin is an additional tool for keeping blood sugar in check, though it can be tricky to use because patients must adjust their insulin when taking it.

Symlin will be the only therapy for the treatment of type 1 diabetes other than insulin. Patients with type 2 diabetes already have several other types of oral therapies available.

The safety and efficacy of Symlin were studied in approximately 5000 patients. Overall Symlin therapy was associated, in patients with both types of diabetes, with improvements in the control of blood glucose and with weight loss. So-called "tight" control of blood sugar is desirable in all patients with diabetes in order to reduce risks for long-term adverse consequences of the disease, including blindness, kidney disease, and vascular disease.

Symlin is to be used only in combination with insulin to help lower blood sugar during the 3 hours after meals. Symlin will have a Medication Guide (FDA-approved patient labeling) and a Risk Minimization Action Plan (RiskMAP) due to three areas of concern. First, the principle risk associated with Symlin therapy is hypoglycemia, and this risk is greatest in patients with type 1 diabetes and in patients with gastroparesis (motility problems of the stomach-a long-term complication of diabetes). Second, the potential for medication errors, specifically mixing of Symlin with insulin in the same syringe, which can alter the activity of the insulin, is addressed in the Medication Guide and in physician labeling. Finally, the potential for off-label use in patients where the benefit/risk profile has not been characterized or demonstrated is also a concern and will be monitored by the sponsor.

The Medication Guide informs patients that Symlin should only be used if they are already using their insulin as prescribed, but still need better blood sugar control; will follow their doctor’s instructions exactly; will follow-up with their doctor often; will test their blood sugar levels before and after every meal, and at bedtime; and understand how to adjust Symlin and insulin doses.

Symlin should not be used if patients cannot tell when their blood sugar is low, have gastroparesis (slow stomach emptying), or are allergic to pramlintide acetate, metacresol, D-mannitol, acetic acid, or sodium acetate.

Side effects associated with Symlin include but are not limited to nausea, vomiting, abdominal pain, headache, fatigue and dizziness.

Symlin has not been evaluated in the pediatric population.

Next month, Amylin is expected to receive FDA approval of its second drug, Exenatide, also for diabetes. The company is developing that drug with industry giant Eli Lilly & Co., the leading provider of insulin.

Amylin almost abandoned Symlin when later in 1998, clinical trials showed no benefit to patients receiving the drug.

Ginger Graham, Amylin’s chief executive attributed some of the hurdles Amylin faced to the fact that the company was developing a drug that was totally new. "It was a brand-new science," she said. "We had many disappointments, but Amylin took on the challenge to advance new ideas."
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