US FDA approves Novartis' Starlix®

27-Dec-2000

Novartis announced today that the US food and Drug Administration (FDA) has granted marketing approval for Starlix® (nateglinide), the first in a new class of oral antidiabetic drugs that restores early insulin secretion, a fundamental defect in type 2 diabetes. It is indicated for use as both monotherapy and in combination with metformin, another oral antidiabetic medication, in patients whose blood glucose (sugar) is not controlled by diet and exercise. In the United States, more than 13 million people have type 2 diabetes and the incidence is expected to increase.

"Starlix is unique because it mimics the body's natural response to a meal, quickly providing insulin when it's needed most and then quickly turning off when insulin is no longer needed," said Thomas Ebeling, CEO of Novartis Pharma AG. "This restoration of early insulin response helps prevent dangerous mealtime glucose spikes that may lead to serious long-term complications."

There is an increasing body of scientific evidence that mealtime glucose spikes contribute to damage of vital organs, including the heart, and are an independent risk factor for cardiovascular morbidity and mortality. Cardiovascular disease causes a significantly large proportion of deaths among patients with type 2 diabetes. In addition to effectively lowering overall blood sugar levels (as measured by HbA1c), Starlix restores insulin secretion, thus preventing the dangerous increases in blood glucose levels or "mealtime glucose spikes" that many type 2 diabetes patients experience following meals.

"Patients spend up to half their day with elevated post-meal glucose levels, which can be damaging in the long-term. Increasingly then, the control of mealtime glucose spikes is being recognised as an important goal in diabetes management," said Dr Joerg Reinhardt, Head of Clinical Research and Development at Novartis Pharma AG. "Now effective treatment is available which can be taken in convenient tablet form without titration up to 30 minutes before eating. It's as easy to remember as eating."

The approval was based on clinical trials involving more than 3100 patients with type 2 diabetes. In monotherapy, Starlix was shown to prevent the dangerous mealtime glucose spikes in addition to significantly reducing HbA1c, a measure of long-term control. In addition, by combining Starlix with an agent that has a complementary mode of action, such as metformin, the entire glycemic risk can be optimally managed. The combination achieved increased reductions in HbA1c, managing both chronic glucose toxicity and acute toxicity caused by the mealtime glucose spike. This effect was achieved with minimal weight gain and low incidence of hypoglycemia, low blood glucose levels, which can be life-threatening.

About Starlix Starlix is a derivative of the amino acid D-phenylalanine and has a chemical structure and mode of action distinct from other oral antidiabetics. Starlix has a strong safety and tolerability profile. While many other anti-diabetic drugs act at the same level throughout the day, increasing the risk of hypoglycemia when insulin is not needed, the activity of Starlix tends to decrease as soon as glucose levels return towards normal. Its fast-on, fast-off action helps prevent dangerous mealtime glucose spikes without prolonging late stage insulin secretion, which explains the relatively low potential for hypoglycemia with Starlix.

On 17 December 1999, Novartis Pharma AG submitted an application for marketing approval for Starlix to the European Medicines Evaluation Agency (EMEA). Starlix is currently approved for marketing in several countries including Switzerland and Brazil. Yamanouchi and Hoechst Marion Roussel market nateglinide in Japan. Novartis licenses Starlix from Ajinomoto Co. Inc., Japan, and has a co-marketing and co-promotion agreement with Merck KgaA.

Diabetes – A Growing Worldwide Problem Globally, it is estimated that 125 million people have type 2 diabetes. This number i

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