What is Lusduna - Insulin Glargine and what is it used for?
Lusduna is a medicine used in patients at least 2 years of age to treat diabetes. It contains the active substance insulin glargine.
Lusduna is a "biosimilar medicine". This means that Lusduna is very similar to a biological medicine (also known as a 'reference medicine') that has already been authorized in the European Union (EU). The reference medicine for Lusduna is Lantus. For more information on biosimilar medicines, see the questions and answers by clicking here.
How is Lusduna - Insulin Glargine used?
Lusduna is available in a disposable pre-filled pen and can only be obtained with a prescription. It is given by subcutaneous injection in the abdominal area, at the level of the deltoid or thigh.
Lusduna should be given once a day at the same time every day. The dose of Lusduna is adjusted for each patient and depends on the level of glucose (sugar) in the blood and treatment with other insulin medicines. In patients with type 2 diabetes, Lusduna can also be given together with other oral antidiabetic medicines.
For more information, see the package leaflet.
How does Lusduna - Insulin Glargine work?
Diabetes is a disease in which the blood sugar level is high because the body cannot produce insulin (type 1 diabetes) or because the body does not produce enough insulin or cannot use it effectively (type 2 diabetes). Lusduna is a replacement insulin that acts in a similar way to the insulin produced by the body and helps glucose to pass from the blood to the body's cells. By controlling the level of glucose in the blood, the symptoms of diabetes are reduced and complications are avoided.
Insulin glargine, the active ingredient in Lusduna, enters the bloodstream more slowly than human insulin after injection; therefore, it is effective longer.
What benefit has Lusduna - Insulin Glargine shown during the studies?
Extensive laboratory studies that have compared Lusduna with Lantus have shown that the insulin glargine contained in Lusduna is very similar to that present in Lantus, in terms of chemical structure, purity and biological activity. Two additional studies have shown that Lusduna is absorbed into the body and acts on blood glucose in the same way as the reference medicine, Lantus.
Lusduna is a biosimilar medicine, therefore efficacy and safety studies have not been necessary as these are already well known for insulin glargine.
Two supporting studies found that the efficacy of a daily dose of Lusduna was comparable to that of Lantus. In both studies, the main measure of effectiveness was the change, after 24 weeks of treatment, in the level of glycosylated hemoglobin (HbA1c) in the blood, a substance that indicates how effectively glucose is controlled in the blood.
In the first support study, which involved 506 patients with type 1 diabetes, the average percentage of HbA1c decreased from 8.0 to 7.4% with both Lusduna and Lantus. In the second study, which involved 531 patients with type 2 diabetes, the average percentage decrease in HbA1c was between 8.3% and 7.2% with Lusduna and between 8.4% and 7.2% with Lantus .
What are the risks associated with Lusduna - Insulin Glargine?
The most common side effect with Lusduna (which may affect more than 1 in 10 people) is hypoglycaemia (low blood glucose). For the full list of restrictions and side effects reported with Lusduna, see the package leaflet.
Why has Lusduna - Insulin Glargine been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements for biosimilar medicines, Lusduna has been shown to have a comparable quality, safety and efficacy profile to Lantus. Therefore, the CHMP considered that, as in the case of Lantus, the benefits outweigh the identified risks and recommended the granting of the marketing authorization for Lusd
What measures are being taken to ensure the safe and effective use of Lusduna - Insulin Glargine?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lusduna have been included in the summary of product characteristics and the package leaflet.
More information on Lusduna - Insulin Glargine
The full EPAR for Lusduna can be found on the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about treatment with Lusduna, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
