Please login to the form below

Not currently logged in
Email:
Password:

US prescribing info update for Onglyza

The FDA has approved an update to prescribing information for Onglyza, a type 2 diabetes therapy from AstraZeneca and Bristol-Myers Squibb

The US Food and Drug Administration (FDA) has approved an update to prescribing information for Onglyza (saxagliptin), a type 2 diabetes therapy from AstraZeneca (AZ) and Bristol-Myers Squibb (BMS).

The prescribing information will be updated to reflect data from two clinical studies, the first of which investigated the safety and efficacy of Onglyza in patients with moderate to severe renal impairment or end-stage renal disease (ESRD). Data at 12 weeks showed that Onglyza 2.5mg once-daily significantly improved glycosylated haemoglobin (HbA1c) from baseline compared to placebo when added to patients' current diabetes treatment.

The second study, which took place over 52 weeks, compared Onglyza to titrated glipizide in patients with inadequate glyceamic control on metformin therapy plus diet and exercise. Data showed that Onglyza plus metformin provided similar HbA1c reductions from baseline. Onglyza plus metformin also resulted in significantly less confirmed hypoglycaemia, as well as weight loss compared to weight gain versus titrated glipizide plus metformin.  

Onglyza was approved by the FDA in July 2009 as an adjunct to diet and exercise to improve glyceamic (blood sugar) control in adults with type 2 diabetes mellitus in multiple clinical settings. 

Onglyza is approved in 56 countries, including the US, Canada, Mexico, Chile, India, Brazil, Argentina and 30 European nations and has been submitted for regulatory review in more than 87 countries.

Bristol-Myers Squibb and AstraZeneca produce Onglyza in partnership as part of a collaboration set up between the two companies in January 2007 to research, develop and commercialise select investigational drugs for type 2 diabetes.

23rd February 2011

Share

PMEA Awards 2020

COVID-19 Updates and Daily News

Featured jobs

PMHub

Add my company
Dovetail

We’re a specialist health consultancy that supports companies, healthcare professionals and patients to work hand in hand with a common...

Latest intelligence

InSite Events™ National Pharma Meeting: A Customer Story
How our client leveraged Impetus Digital’s white-glove service, 360° coverage and care, and award-winning InSite Events™ platform to successfully transfer their annual national meeting online....
Fear or encouragement, which is best to drive behaviour change?
The communications industry depends on fear of the perceived loss of something, in order to create the hope found in a product benefit. But, if if left too long unchecked,...
The unheard, unseen, and uncorrected effects of COVID-19
The disproportionate effects of the pandemic have been highlighted amongst ethnic minorities, so is it likely that ethnic minorities will be more worried about participating? And could this exacerbate inequalities...

Infographics