AZ-BMS launch Onglyza in Europe
pharmafile | October 19, 2009 | News story | Sales and Marketing | AZ, BMS, DPP-4, Onglyza, diabetes
Bristol-Myers Squibb and AstraZeneca’s long-awaited type II diabetes drug Onglyza has been launched in the UK, its first European market.
Designed to improve blood sugar control, Onglyza (saxagliptin) can be combined with metformin, a sulphonylurea or a thiazolidinedione when those drugs, plus diet and exercise, have not worked sufficiently.
“Saxagliptin will provide another option for the many people with type 2 diabetes who are not achieving optimal disease control with the current treatments available,” said BMS UK general manager Frederic Duchesne and AstraZeneca medical director Guy Yeoman in a joint statement.
Like MSD’s Januvia (sitagliptin) and Novartis’ Galvus (vildagliptin), Onglyza is a dipeptidyl peptidase-4 (DPP-4) inhibitor.
The drugs work by preventing the breakdown of gut hormones, called incretins, which are released after food, and by increasing the body’s utilisation of glucose.
In trials saxagliptin was shown to improve glycaemic control, with no increased risk of side effects such as weight gain and greater chance of hypoglycaemic episodes.
Onglyza, which received European approval earlier this month, can be taken as a 5mg once-daily tablet with or without a meal.
Arthritis treatment Vimovo
Meanwhile, AstraZeneca has also submitted an EU marketing authorisation application for Vimovo for the treatment of the signs and symptoms of osteoarthritis (OA), rheumatoid arthritis (RA) and ankylosing spondylitis (AS).
Vimovo is a combination of enteric-coated naproxen, a pain-relieving non-steroidal anti-inflammatory drug (NSAID) and immediate release esomeprazole, a proton pump inhibitor (PPI).
Formerly known as PN 400, it is being developed with Pozen.
Around 150 million people worldwide suffer from osteoarthritis, and the brand would be used in patients at risk of developing NSAID-associated gastric ulcers.
“Up to one third of osteoarthritis patients change therapy in a year, primarily due to lack of pain-relieving efficacy,” said Lori Kreamer, AstraZeneca’ global product vice president.
She added that 60% of patients do not continue with NSAID and PPI combination treatment after the third NSAID prescription.
The manufacturers believe that Vimovo’s attraction lies in offering both in a single tablet.
In June Pozen submitted a New Drug Application to the US Food and Drug Administration (FDA) for Vimovo.
Crestor in the US
Also in the US, the FDA has approved AstraZeneca’s Crestor (rosuvastatin calcium) for use in children ages 10-17 with genetic disease heterozygous familial hypercholesterolemia (HeFH).
The drug can be used when elevated cholesterol is not reduced by diet alone. HeFH can lead to increased risk of early cardiovascular disease.
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