This report reviews the medicines already evaluated by the Spanish Agency for Medicines and Health Products (hereinafter Aemps), considered of greater interest for the health professional.These are positive technical opinions of the AEMPS that are prior to the authorization and put in the drug market, which will happen within a few months.
Once the medications have been authorized, all the information of each of them (from the technical file and prospect, to its conditions of prescription, use and real availability in the market) can be consulted on the AEMPS website, withinThe CIMA section: Online Information Center for AEMPS Medicines.
fiasp (Asparta insulin)
Approved indication: treatment of diabetes mellitus in adults.
It will be available in injection solution (100 units/ ml).
The active substance is insulin asparta, an analogous of fast action of insulin.It acts in the same way as natural insulin, facilitating the absorption of glucose to skeletal and adipose muscle tissue and inhibiting glucose output from the liver.
He has shown that he controls the level of blood glucose.
The adverse reaction observed more frequently during clinical development was hypoglycemia.
suliqua (insulin glargina/lixisenatida)
Approved indication:
Indicated in combination with metformin, in the treatment of adults with type 2 diabetes mellitus to improve glycemic control, when this has not been achieved with metformin in monotherapy or metformin in combination with other oral hypoglycemic medications or basal insulin.
It is a combination of fixed dose of insulin glargina, an analogue of insulin, and legendly, a selective agonist of the peptide receptor similar to type 1 glucagon (LPG-1).Glargine insulin is specifically binded to the human insulin receiver, producing the same pharmacological effects as this one.Lixisenatid stimulates glucose -dependent insulin secretion and reduces glucagon release.
The data showed that in combination with metformin it has a clinically relevant effect on glycemic control in patients with type 2 diabetes mellitus. Suliqua has no effect on body weight.
The adverse reactions observed more frequently during clinical development were hypoglycemia, dizziness and gastrointestinal adverse reactions such as nausea and diarrhea.
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