Sanofi withdraws Adlyxin from the US as lixisenatide injection is listed discontinued

Adlyxin (lixisenatide), a once-daily injectable GLP-1 receptor agonist for type 2 diabetes, will no longer be available in the United States, according to Sanofi ^[1]. The company's prescriber site states the product is being withdrawn from the US market, and the FDA's drug shortages tracker lists lixisenatide (Adlyxin) injection as discontinued ^[1].

Adlyxin received FDA approval in 2016. It is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes ^[1]. It belongs to the glucagon-like peptide-1 (GLP-1) receptor agonist class, the same broad family as several other diabetes medicines still sold in the US ^[1].

The FDA shortage entry for lixisenatide (Adlyxin) injection was accessed on February 6, 2023, and carries a discontinued status ^[1]. A posting on that tracker indicates the product has been discontinued ^[1].

Other GLP-1 receptor agonists indicated for diabetes remain available, including Bydureon Bcise (exenatide extended-release for subcutaneous injection), Byetta (exenatide for subcutaneous injection), Ozempic (semaglutide for subcutaneous injection), Rybelsus (semaglutide tablets), Trulicity (dulaglutide for subcutaneous injection) and Victoza (liraglutide for subcutaneous injection) ^[1]. Of those, Rybelsus is a tablet and the others are injections ^[1]. Each is a different molecule from lixisenatide, so none is the same drug.

Several details have not been reported. It is not known how many people in the US were using Adlyxin, how much pharmacy stock remains, when the last shipments were made, or whether lixisenatide will stay available in the US in any other product ^[1].

Why it matters for patients

Adlyxin's exit narrows the list of GLP-1 medicines that US patients and prescribers can choose from ^[1]. People who still hold Adlyxin prescriptions may find that their pharmacy can no longer fill them, and people starting a GLP-1 medicine will not have lixisenatide as an option in this country ^[1].

Which of the remaining GLP-1 drugs is appropriate for a given person is a clinical decision. It depends on factors specific to that person, and that conversation belongs between a patient and their prescriber rather than at the pharmacy counter.

The FDA's shortage listing is a public way to check whether a product is available, and Sanofi's notice was aimed at prescribers ^[1]. Patients who want to know whether their own prescription can still be filled can ask their pharmacy.

The discontinued status applies to lixisenatide (Adlyxin) injection ^[1]. The tracker does not address other products, and no end date for remaining US supply has been given ^[1].