AstraZeneca said Friday that its once-weekly diabetes drug BYDUREON has been approved in the United States for use in patients 10 to 18 years old with type 2 diabetes. , according to Reuters.

Everything you need to know about Bydureon in these questions and answers:

What is Bydureon?

The generic name for BYDUREON is exenatide, and the trade name for BYDUREON BCise.

What is the form of a pharmacist?

Bydureon is an injectable suspension.

How often is it given?

Bydureon is given once weekly.

“This decision is a milestone in the care of these young patients (10-18 years) by providing a convenient once-weekly treatment option,” said Maine Bangalos, chief executive officer of AstraZeneca.

How does Bydureon work?

Bydureon belongs to a class of drugs that are a glucagon-like peptide-1 receptor agonist, and it works by activating the Glucagon-like peptide 1 protein-1 (GLP-1) in the pancreas. production of the hormone insulin.

Who approved Bydureon?

Bydureon is approved by the US Food and Drug Administration (FDA).

The US approval comes about a month after data from a late-stage study showed the drug significantly reduced blood glucose levels in teens compared to a placebo.

Bydureon was already approved in America for adults with type 2 diabetes.

What is type 2 diabetes?

Type 2 diabetes is the most common form of diabetes in which the body cannot use or produce enough of the hormone insulin to convert blood sugar into energy.

Bydureon is intended to help reduce blood sugar levels along with diet and exercise.

When was Bydureon first approved?

According to AstraZeneca, Bydureon B-Syse was first approved in the United States in October 2017 as a once-weekly self-injection device for adults with type 2 diabetes, whose blood sugar remains uncontrolled using one or more oral medications in addition to Diet and exercise, to improve blood sugar control.

Bydureon B-Syce was also approved for use in the European Union in August 2018.

caveats

According to AstraZeneca, there are caveats, including:

  • Bydureon is not recommended as a first-line treatment for patients with type 2 diabetes who are not adequately controlled by diet and exercise.

  • It should not be used to treat type 1 diabetes

  • It should not be used with other medicines that contain exenatide.

  • Exenatide caused an increase in thyroid C-cell tumors at clinically relevant exposures in rats.

    It is not known whether Bydureon causes C-cell tumors, including medullary thyroid carcinoma (MTC) in humans, as the human link to rodent C-cell tumors has not been established.

  • Bydureon B-Sis is contraindicated in patients with a personal or family history of medullary thyroid carcinoma or in patients with endocrine neoplasia syndrome type II.

Patients should be informed regarding the potential risks and reported symptoms of thyroid tumors, for example:

  • lump in the neck

  • dysphagia

  • shortness of breath

  • Persistent hoarseness

Contraindications

  • Personal or family history of medullary thyroid cancer.

  • Patients with multiple endocrine neoplasia type II syndrome.

  • Previous serious hypersensitivity reactions to exenatide or components of the product.

  • A history of drug-induced immune-related thrombocytopenia (drug-induced, immune-mediated thrombocytopenia) mediated by exenatide products.