New therapies show promise in treating diabetes
Diabetes medications were the most expensive traditional therapy drugs in 2016, with an overall trend of 19.4%, according to the latest Express Scripts drug trend report. This positive trend is reflective of increases in both utilization and cost.
Here’s how pipeline developments could change the landscape.
“While I do not see any game-changing medications within the diabetes class that will reach the market within the next several years, there are a few updates that we are watching,” says Chris Peterson, director in the emerging therapeutics department at Express Scripts.
He points to the continued growth of the sodium-dependent glucose cotransporter-2 (SGLT-2) inhibitor class—sparked by the positive cardiovascular outcomes from empagliflozin (Jardiance, Boehringer Ingelheim/Eli Lilly), a previously approved SGLT2 inhibitor. Pipeline SGLT-2 inhibitors include investigational ertugliflozin (Merck and Pfizer) and bexagliflozin (Chugai Pharma), both in phase 3 development at press time. Sotagliflozin (Lexicon Pharmaceuticals), a first-in-class oral dual SGLT-1 and SGLT-2 inhibitor for type 1 and type 2 diabetes, also in phase 3. If approved, it will be the first oral drug approved for type 1 diabetes, a disease that typically has been managed by lifestyle modifications and insulins, says Farrah Wong, PharmD, director, pipeline and drug surveillance at OptumRx.
The glucagon-like peptide-1 (GLP-1) analog class is also expected to grow, says Peterson. This is driven by cardiovascular outcomes data with liraglutide (Victoza, Novo Nordisk) and the introduction of the fixed-dose combination GLP-1 agonist/long-acting insulin products, insulin glargine and lixisenatide injection (Soliqua 100/3, Sanofi) and insulin degludec/liraglutide (Xultophy, Novo Nordisk).
Semaglutide is a GLP-1 agonist in development for glycemic control in patients with type 2 diabetes. It is being developed as both subcutaneous formulation from Novo Nordisk and oral form from Novartis. If approved, it will be the first oral GLP-1 agonist on the market.
“As oral drugs are easier to administer and less invasive than injectable drugs, oral semaglutide may offer these advantages over other GLP-1 agonists,” says Wong. “Furthermore, type 2 diabetics will have another oral therapeutic option in a class of drugs that thus far were only injectable drugs.”
Exenatide osmotic mini-pump (ITCA 650, Intarcia Therapeutics, Inc.) is a subcutaneous implant that continuously delivers the GLP-1 agonist, exenatide, for three months (introductory dose) or six months (maintenance dose) to treat type 2 diabetes. Approval is expected in November 2017, says Peterson.
New insulin products are also expected to receive approval soon, including insulin tregopil (Biocon Ltd.), an oral insulin in phase 2 development for type 1 and type 2 diabetes.
“Currently, insulins are either injected or inhaled,” says Wong. “If an oral insulin product is available, the ease of administration may drive some of the market share to shift from injectable/inhaled insulins to the oral product.”
Insulin glargine injection (Basaglar, Eli Lilly/Boehringer Ingelheim) approved last year, was the first “follow-on” insulin glargine product to treat diabetes. Another “follow-on” insulin glargine product, known as MK-1293 (Merck/Samsung Bioepis), will be competing as a brand product within the market and is expected to be approved in the second quarter of 2017. Basalog is yet another insulin glargine product currently in phase 3 development; however, it is not yet clear whether the manufacturer, Mylan, will seek approval as a competing brand or as a generic to Lantus (Sanofi). Finally, Sanofi is developing SAR342434, a follow-on protein to Lilly's Humalog (insulin lispro), for the treatment of diabetes mellitus. If approved, it will compete as a brand with the other rapid-acting insulins.