Onglyza expands European licence
pharmafile | March 4, 2011 | News story | Sales and Marketing |Â Â AZ, AstraZeneca, BMS, Bristol-Myers Squibb, Onglyza, diabetes, renal impairment, saxagliptin, type II diabetesÂ
European regulators have approved a licence extension for diabetes treatment Onglyza, making it the first drug in its class that can also treat moderate or severe renal impairment.
It is estimated that more than 25% of patients with type II diabetes have moderate or severe renal impairment and doctors will now have the option of prescribing Onglyza, but only at half its normal 5mg dose.
They will also need to assess their patients’ renal function prior to treatment commencing and, in keeping with routine care, regularly monitor them after treatment begins.
The companies further note that “as experience in patients with severe renal impairment is very limited, [Onglyza] should be used with caution in this population and is not recommended for patients with end-stage renal failure”.
Patients with mild renal impairment will be able to take a full 5mg dose of Onglyza (saxagliptin).
The drug is co-promoted by AstraZeneca and Bristol-Myers Squibb and currently indicated to help type II diabetics keep their sugar levels low.
Ben Adams
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