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Byetta approved for use with Lantus

BY Alaric DeArment

INDIANAPOLIS — A diabetes drug made by Eli Lilly and Amylin Pharmaceuticals has received approval from the Food and Drug Administration for use with an insulin product made by Sanofi.

Lilly and Amylin said Byetta (eventide) won approval from the FDA as an add-on therapy for patients with Type 2 diabetes taking Sanofi’s Lantus (insulin glargine [rDNA origin]) who have not achieved adequate blood sugar control on Lantus alone.

"This expanded use for Byetta is important for clinical care in that it provides a new option for the many patients with Type 2 diabetes who are not achieving treatment goals," University of North Carolina School of Medicine professor John Buse said on behalf of Lilly and Amylin. "Byetta is well-suited for use with insulin glargine, offering a simple fixed-dose regimen that can help improve control of blood sugar overall and after meals."


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Study: African-American women have 10x greater risk of diabetes if diagnosed with gestational diabetes

BY Michael Johnsen

PASADENA, Calif. — African-American women who develop gestational diabetes mellitus during pregnancy face a 52% increased risk of developing diabetes in the future, compared with white women who develop GDM during pregnancy, according to a Kaiser Permanente study published online Thursday in the journal Diabetologia.

African-American women are less likely to develop GDM during pregnancy, but for those who were diagnosed with having GDM, their future overt diabetes risk is the greatest among all race/ethnic groups. Although Asian/Pacific Islander women are much more likely to develop GDM than African-American or non-Hispanic white women, their future diabetes risk after GDM is similar to that for non-Hispanic white women, the study found.

"Race and ethnicity should be considered among the risk factors for Type 2 diabetes when physicians and nurses counsel women about their risk of developing diabetes after a pregnancy complicated by GDM," stated study lead author Anny Xiang, a senior research scientist at the Kaiser Permanente Department of Research and Evaluation.

This study, which consisted of 77,666 ethnically diverse women who gave birth from 1995 to 2009, found that African-American women who developed GDM had the highest risk of developing overt diabetes in the future in comparison with women from other racial and ethnic groups. For African-American women, their risk of developing diabetes was almost 10 times greater if they had developed GDM during a past pregnancy than if they did not develop GDM. In comparison, the relative risks were 6.5 times greater for non-Hispanic White women, 7.7 times greater for Hispanic women and 6.3 times greater in Asian/Pacific Islander women.

GDM is defined as glucose intolerance that typically occurs during the second or third trimester and most prevalent in Asian/Pacific Islanders (17% in the study population) and least prevalent in African-American women (7% in the study population). GDM can lead to such complications as early delivery and cesarean delivery and increases the baby’s risk of developing diabetes, obesity and metabolic disease later in life. GDM typically goes away after pregnancy but risk of overt diabetes in the future is a concern.

"All women diagnosed with GDM should be screened for diabetes soon after their delivery and subsequently at regular intervals," Xiang said. "These women would benefit from lifestyle changes such as changes in diet and increases in physical activity that can reduce diabetes risk. … Our study shows that prevention messages, while important to all women who develop GDM, are particularly important for African-American women."


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Bristol-Myers Squibb announces executive changes

BY DSN STAFF

NEW YORK — Bristol-Myers Squibb announced changes to its senior management team, including the appointment of its U.S. pharmaceuticals president.

The drug maker said SVP oncology and immunology global commercialization Giovanni Caforio has been promoted to president of U.S. pharmaceuticals. Additionally, Bristol named Charles Bancroft and Béatrice Cazala as EVPs. Bancroft will add to his role of CFO operational responsibility for the pharmaceutical business in Latin America, Middle East, Africa, Canada, Japan and several other countries in the Pacific Rim. Meanwhile, Cazala will add responsibility for global policy to her role leading global commercialization, Europe and emerging markets.

In related news, Anthony Hooper, SVP commercial operations and president of U.S., Japan and intercontinental, has decided to leave the company. He has joined Amgen as EVP global commercial operations.

All of the executives will report to Bristol CEO Lamberto Andreotti.

“A focus on developing talent at all levels is a key element of our Bristol-Myers Squibb culture,” Andreotti said. “I am excited to expand the roles of Giovanni, Charlie and Béatrice, and look forward to working with these three senior leaders and the rest of my management team to continue to successfully execute our BioPharma strategy.”


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