A new Diabetes drug about to hit the mkt! Any comments on how "good" this new drug seems to be?
Takeda America Research and Development Center, Inc.
Submits NDA For Anti-Diabetic Drug ACTOS(TM) for
Treatment of Type 2 Diabetes
PRINCETON, N.J., Jan. 18 /PRNewswire/ -- Takeda America Research and Development Center, Inc. announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) to market ACTOS™ (pioglitazone hydrochloride) tablets, an anti-diabetic agent for the treatment of type 2 diabetes, as a monotherapy and combination therapy in the United States.
Studied in more than 2,500 patients in the United States to date, ACTOS (pioglitazone hydrochloride) is a member of a new class of oral diabetes agents called thiazolidinediones (TZDs).
Unlike other classes of type 2 anti-diabetes drugs that stimulate the body's insulin production or limit glucose production by the liver, TZDs reduce insulin resistance -- the body's inability to effectively
use its own insulin. Insulin resistance has been linked as a potential cause of type 2 diabetes.
Upon receiving regulatory approval, Takeda Pharmaceuticals America, Inc., the U.S. marketing subsidiary of Takeda Chemical Industries, LTD., will co-promote ACTOS (pioglitazone hydrochloride) with Eli Lilly and Company (NYSE: LLY - news). The partnership was announced
after the two companies agreed in 1998 to co-promote the drug in the U.S.
''This NDA submission represents Takeda's commitment to developing and marketing innovative diabetes treatments in the United States,'' said Mikihiko Obayashi, Ph.D., Takeda America Research and Development Center, Inc. President. ''We believe this new drug will have a significant place in the medical treatment of patients with this devastating disorder.''
Diabetes affects the body's ability to produce or respond properly to insulin, a hormone that allows blood sugar to enter the cells of the body and be used for energy. Type 2 diabetes, formerly known
as non-insulin-dependent diabetes, is the most common type of diabetes, affecting about 15 million Americans. It usually occurs in people over age 45. Left untreated, diabetes can lead to serious
health complications, including blindness, amputation, kidney failures and heart attacks. All told, diabetes consumes $92 billion in U.S. health care costs annually.
''The clinical studies indicate that ACTOS (pioglitazone hydrochloride) improves glycemic control in
terms of fasting blood glucose and hemoglobin A1c,'' said Roberta L. Schneider, MD, Vice President, Drug Development, and lead clinical researcher at Takeda America Research and
Development Center. ''Because the drug attacks one of the basic causes of the disease, ACTOS (pioglitazone hydrochloride) offers a more logical approach to treatment than many other therapies.''
Takeda America Research and Development Center, Inc. and Takeda Pharmaceuticals America, Inc. are wholly-owned subsidiaries of Takeda Chemical Industries LTD (Takeda), a global pharmaceutical company based in Osaka, Japan. Internationally recognized as a leader in research and development, Takeda focuses on treatments for diabetes, cardiovascular and allergic diseases, bone and joint and central nervous system disorders and atherosclerosis.
SOURCE: Takeda America Research and Development Center, Inc. |
