USA — The US Food and Drug Administration (FDA) has approved a label update for Novo Nordisk’s oral semaglutide (Rybelsus) allowing the agent to be used as an initial treatment to lower blood sugar levels.
This means that doctors can now prescribe Rybelsus to their patients right away, instead of starting with other diabetes medications, such as metformin, first.
This label expansion will allow it to compete more directly with other oral drugs from Merck & Co. and Eli Lilly.
Rybelsus stimulates insulin production in patients with type 2 diabetes, the most common form of the disease, and is meant to be taken once a day.
One of the primary benefits of Rybelsus is that it is the only approved Glucagon-like peptide-1 (GLP-1) medication that can be taken as a pill, making it more convenient for diabetics to use.
Rybelsus can also aid in the weight loss of people with type 2 diabetes. This is due to the medication’s ability to suppress appetite and increase feelings of fullness, resulting in weight loss.
This is especially important for people with type 2 diabetes, as obesity is a major risk factor for the disease’s development.
Rybelsus, which functions similarly to Novo’s Ozempic and Lilly’s Trulicity, was approved by the FDA in 2019 as a daily oral alternative to those two drugs, which require weekly injections.
However, the initial approval was accompanied by a recommendation that doctors not prescribe Rybelsus as a first-line treatment for diabetics who are unable to control their blood sugar levels through diet and exercise alone.
In comparison, Merck’s Januvia and Lilly’s Jardiance already had approvals for that use.
The new application for Rybelsus comes as diabetes drug competition heats up. Rybelsus is the only oral treatment in the GLP-1 agonist class, but it must be taken daily, whereas the most recent injectable drugs can be taken once a week.
In contrast to Jardiance and other similar medications, Rybelsus has not been shown in a large study to significantly reduce the risk of cardiovascular death or complications, though it does not appear to increase the risk of those outcomes.
Meanwhile, Lilly has introduced Mounjaro, a new type of diabetes medication that targets GLP-1 and another hormone.
GlobalData projects that the Type 2 Diabetes market will see significant growth from 2019–29, with nine major markets (i.e., U.S, France, Germany, Italy, Spain, UK, Japan, China, and India) having a total of US$45.9 billion in sales in 2019, increasing to $US136.2 billion in 2029, with drug sales almost doubling at a compound annual growth rate (CAGR) of 11.5%.
There are multiple drugs in the pipeline more so biosimilar therapies, with a significant number developed in the emerging markets of India and China by domestic pharmaceutical companies for their own rapidly growing markets.
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