Cardio Metabolic Health Congress – Official Blog

PCSK9 Inhibitors: 1 Year After Approval

One year after FDA approval, are PCSK9 inhibitors living up to expectations?

It’s been about 1 year since the two currently available PCSK9 inhibitors, evolocumab and alirocumab, received US FDA approval. (Bococizumab is still completing phase 3 studies.) Uptake, as most in the healthcare community know, has been slow, largely due to the cost associated with the two therapies.

The US FDA recently approved a monthly single-dose administration option for evolocumab. The system consists of a hands-free device which is designed to provide 420 mg of evolocumab in a single dose and allows patients the freedom of being able to continue with moderate physical activity such as walking, reaching, and bending. The cost is expected to remain similar to twice weekly dosing, and given how new it is, it remains to be seen what kind of impact on clinical practice it will have. Read more

GLP-1 Receptor Agonist Lixisenatide Approved by US FDA

The GLP-1 receptor agonist lixisenatide has received US FDA approval for the treatment of adults with type 2 diabetes as an adjunct to diet and exercise. Approval was based on 11 clinical trials that evaluated more than 11,000 patients, including a cardiovascular outcomes trial, ELIXA, that showed no increase in adverse cardiovascular events. Efficacy studies showed lixisenatide improved HbA1c when used alone and in combination with other therapies, including sulfonylureas, metformin, pioglitazone, and basal insulin.

Lixisenatide will be available in a disposable prefilled pen.

Reference: Medscape Medical News. GLP-1 agonist lixisenatide okayed for type 2 diabetes in US.