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FDA OKs Lilly-Amylin Drug for Type 2 Diabetes

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US regulators have approved a diabetes drug derived from lizard saliva for patients who have not responded to other treatments, the drug’s developers, Eli Lilly and Co. and Amylin Pharmaceuticals Inc., said on Friday. The U.S. Food and Drug Administration approved exenatide, an injectable drug to be sold under the brand name Byetta, as an additional therapy for patients with Type II diabetes — the most common form — whose blood sugars are not sufficiently controlled by two oral medications. Analysts expect the drug could eventually generate sales of about $1 billion to $2 billion. Shares of Amylin fell 8 percent to $16.73 in midday trade on the Nasdaq, after earlier touching a two-year low of $16.01. Analysts, however, said the news was positive for Amylin. The companies, which had sought approval only to market Byetta only in combination with other diabetes drugs, said that the FDA also gave conditional approval for Byetta as a stand-alone treatment, subject to further clinical trials. Jamaison Schuler, a spokesman for Eli Lilly, said the FDA’s decision to conditionally approve the drug as a stand-alone treatment is “wonderful news” as the companies had not sought such approval and indicates the agency sees promise in the drug for this use. Some analysts, as well as Lilly, said that investors may be misinterpreting the conditional approval as a negative move. Exenatide is Amylin’s second product on the commercial market. It already sells Symlin, another diabetes treatment. Exenatide, which is a synthetic version of saliva of the Gila monster lizard that lives in the Arizona desert, is the first of a new class of drugs known as incretin mimetics. It mimics hormones, released in the human gut in response to food, that help regulate glucose levels. Trials of 1,446 patients showed about a 1 percent reduction in blood sugar levels in patients who took Byetta along with other oral diabetes medications, including widely used metformin and a class of older drugs called sulfonylureas. Most patients also experience weight loss. Weight gain is seen as a risk factor for diabetes.

The U.S. Food and Drug Administration approved exenatide, an injectable drug to be sold under the brand name Byetta, as an additional therapy for patients with Type II diabetes — the most common form — whose blood sugars are not sufficiently controlled by two oral medications.Analysts expect the drug could eventually generate sales of about $1 billion to $2 billion.Shares of Amylin fell 8 percent to $16.73 in midday trade on the Nasdaq, after earlier touching a two-year low of $16.01. Analysts, however, said the news was positive for Amylin.The companies, which had sought approval only to market Byetta only in combination with other diabetes drugs, said that the FDA also gave conditional approval for Byetta as a stand-alone treatment, subject to further clinical trials.Jamaison Schuler, a spokesman for Eli Lilly, said the FDA’s decision to conditionally approve the drug as a stand-alone treatment is “wonderful news” as the companies had not sought such approval and indicates the agency sees promise in the drug for this use.Some analysts, as well as Lilly, said that investors may be misinterpreting the conditional approval as a negative move.Exenatide is Amylin’s second product on the commercial market. It already sells Symlin, another diabetes treatment.Exenatide, which is a synthetic version of saliva of the Gila monster lizard that lives in the Arizona desert, is the first of a new class of drugs known as incretin mimetics. It mimics hormones, released in the human gut in response to food, that help regulate glucose levels.Trials of 1,446 patients showed about a 1 percent reduction in blood sugar levels in patients who took Byetta along with other oral diabetes medications, including widely used metformin and a class of older drugs called sulfonylureas.Most patients also experience weight loss. Weight gain is seen as a risk factor for diabetes.Patients can inject Byetta as an alternative to taking insulin, which can cause hypoglycemia, or worrisome drops in blood sugar levels that can cause fainting.Because Byetta is not closely linked with hypoglycemia Shao said patients would not have to monitor their blood glucose levels as constantly as insulin users must.”I’ll especially recommend this drug for obese diabetics who are making their best effort to control their diets but are still not losing weight,” said Dr. Stuart Weiss, an assistant professor at New York University Medical School.Shares of Lilly, which has many drugs on the market, were unchanged at $58.00 on the New York Stock Exchange.More than 15 million people in the United States have type II diabetes. Diabetics are unable to produce enough insulin or cannot process their insulin properly, resulting in dangerously high blood-sugar levels, which can lead to heart disease, blindness and amputations if not treated.Amylin Chief Operating Officer Daniel Bradbury said the company has not yet set a price for the drug. He said it could face future competition from Danish drug maker Novo Nordisk, which is working on a rival medicine called Liraglutide.Novartis AG, Merck & Co. Inc. and Bristol-Myers Squibb are also testing diabetes drugs in a different class that try to prolong the gut’s natural insulin secretions.(Source: Reuters Health, April 2005)

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Posted On: 1 May, 2005
Modified On: 16 January, 2014

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