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Amylin's Diabetes Drug Pen Gets OK; FDA Letter Bars Use By Certain Patients
FDA letter bars use by certain patients
In a good quality news/bad news day at Amylin Pharmaceuticals days gone by, the Food and Drug Administration standard the employ of a throwaway pen for the injection of the company's Symlin drug that helps diabetics control high and low spikes in their blood sugar.
But the FDA issued a “not approvable” letter to the San Diego Company saying Symlin could not be worn by diabetics who are captivating basal insulin on your own, or not attractive mealtime insulin to manage their blood sugar subsequent to eating.
Basal insulin is long-acting and destined to make available manage of blood sugar right through the day, as contrasting to bolus insulin, which is in use to manage large changes in blood sugar triggered by the eating of food.
The company thought it would speak to the FDA concerning the not approvable letter.
Symlin is at present accepted in the United States for patients with type 2 or type 1 diabetes who use mealtime insulin and require improved glucose control.
The injection pen can be stored at room temperature subsequent to its primary use, serving create the action extra suitable for patients. The company thought the pens would be obtainable in December.
Analysts did not sight the correspondence as very harmful to the power of Amylin shares.
“It was unforeseen, but this was just leaving to unlock an incremental market opportunity,” said Salveen Kochnover, a forecaster with Jefferies in New York. “There is still opportunity for the company to market Symlin with mealtime insulin.”
Overall, Symlin addresses a niche market and is not the main driver for that company, Kochnover said.
The big driver for Amylin is its diabetes drug Byetta, specially a long-acting account of the drug, she said. The company is expecting to hear from the FDA about approval for the long-acting Byetta sometime during the fourth quarter this year.
Byetta, which is derived from the saliva of the toxic Gila monster lizard, improves blood sugar control in adults with type 2 diabetes. A side effect is weight loss, although the companies are not permissible to market it for that purpose.
The drug, which Amylin co-developed with Eli Lilly, was approved for market in April 2005.
Shares of Amylin closed at $49.55, down 45 cents.