Bristol-Myers gets EU approval for diabetes drug

Oct 05, 2009 By LINDA A. JOHNSON , AP Business Writer

(AP) -- Drugmaker Bristol-Myers Squibb Co. said Monday that its new diabetes drug, Onglyza, has been approved for sale in the European Union's 27 countries.

That means Onglyza will compete with & Co.'s blockbuster Januvia both in the EU and in the United States, where the Bristol Myers drug was approved on July 31.

Onglyza is the first diabetes drug to be launched in Europe by a partnership of New York-based Bristol-Myers and British drugmaker AstraZeneca PLC to develop drugs for type 2 diabetes. It was approved for use with three other standard diabetes drugs, based on six late-stage studies including more than 4,100 patients.

Onglyza and Januvia both are in a newer class of diabetes medicines called DPP-4 inhibitors. They work by increasing insulin production and lowering the production of glucose.

Whitehouse Station, N.J.-based Merck's Januvia and a related drug called Janumet, which includes metformin, constitute Merck's fastest-growing product line, third in overall sales with a total of $1.75 billion in revenue last year.

Onglyza is to be launched in the European Union by year's end; it's already on sale in the U.S.

Analysts have forecast that Onglyza sales could hit as high as $1 billion a year, given the alarming increase in the number of people in developed countries with diabetes. The U.S. market for diabetes medicines alone already exceeds $5 billion annually.

Meanwhile, Bristol and AstraZeneca are in late-stage testing of another potential diabetes drug, dapagliflozin, that works by helping the kidneys eliminate excess glucose.

Onglyza was approved to be used with metformin or another drug from one of two different classes that are often prescribed, along with diet and exercise, when patients are first diagnosed with type 2 diabetes. People with the disorder, most often caused by obesity and inadequate exercise, do not use the insulin made by their body efficiently and may eventually need injected insulin as well as pills to control the disease.

Also Monday, Bristol and AstraZeneca released results of a new study showing that Onglyza with metformin works roughly the same as Januvia with metformin, reducing a key measure of long-term blood sugar level by 0.52 percent, compared with a 0.62 percent reduction for the patients in the Januvia group.

In New York trading, Bristol-Myers shares were down 4 cents at $22.22 while AstraZeneca shares were up 64 cents, or 1.5 percent, at $44.28.

©2009 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

Explore further: FDA approves hard-to-abuse narcotic painkiller

add to favorites email to friend print save as pdf

Related Stories

FDA: Bristol-Myers diabetes drug appears safe

Mar 30, 2009

(AP) -- A potential blockbuster diabetes medication from Bristol-Myers Squibb appears free from heart-related side effects that have plagued similar treatments, federal health officials said Monday.

FDA approves new diabetes treatment

Oct 17, 2006

The U.S. Food and Drug Administration has approved the use of Januvia tablets as the first in a new class of diabetes drugs.

FDA weighs approval of psychiatric drugs for kids

Jun 05, 2009

(AP) -- Three blockbuster psychiatric drugs currently approved for adults also appear to work in adolescents, though federal health officials have concerns about exposing younger patients to the drugs' side effects.

Diabetes drug slows early-onset puberty in girls

Jun 16, 2008

In young girls at risk of early puberty and insulin resistance, the diabetes drug metformin delayed the onset of menstruation and decreased the development of insulin resistance, a risk factor for type 2 diabetes, according ...

Recommended for you

FDA approves hard-to-abuse narcotic painkiller

Jul 25, 2014

(HealthDay)—A new formulation of a powerful narcotic painkiller that discourages potential abusers from snorting or injecting the drug has been approved by the U.S. Food and Drug Administration.

Race affects opioid selection for cancer pain

Jul 25, 2014

(HealthDay)—Racial disparities exist in the type of opioid prescribed for cancer pain, according to a study published online July 21 in the Journal of Clinical Oncology.

FDA approves tough-to-abuse formulation of oxycodone

Jul 25, 2014

(HealthDay)—Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended release) has been approved by the U.S. Food and Drug Administration as a long-term, around-the-clock treatment for severe ...

Tough-to-abuse formulation of oxycodone approved

Jul 25, 2014

(HealthDay)—Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended release) has been approved by the U.S. Food and Drug Administration as a long-term, around-the-clock treatment for severe pain when other ...

EU regulator: Morning-after pill OK for all women

Jul 24, 2014

(AP)—A commonly used morning-after pill is suitable for use by heavier women, the European Medicines Agency said Thursday after a review of the evidence sparked by the French manufacturer's declaration that the drugs didn't ...

Physicians warned about counterfeit medical devices

Jul 24, 2014

(HealthDay)—Physicians should be aware of the prevalence and serious consequences associated with use of counterfeit medical devices, according to a letter to the editor published online July 20 in Lasers in ...

User comments : 0