What happens next following FDA approval of Mounjaro® from Eli Lilly for diabetes?

The FDA on May 13th approved the dual GIP-GLP1-agonist Mounjaro® (tirzepatide) from Eli Lilly for diabetes following the completion of the SURPASS studies (e.g. SURPASS-2 NCT03987919).

Mounjaro® is administered as a weekly injection just like the GLP1-agonist Ozempic® (semaglutide) from Novo Nordisk for diabetes. The table below summarizes products from Eli Lilly and Novo Nordisk that have already been granted FDA approval or candidates still in the drug pipeline.

Semaglutide from Novo Nordisk has also been approved for obesity (Wegovy®) and an oral formulation for diabetes (Rybelsus®).

CompanyDrugFDA approvalAdministrationIndication
Novo NordiskOzempic®2017Weekly InjectionDiabetes
Eli LillyMounjaro®2022Weekly InjectionDiabetes
Novo NordiskWegovy®2021Weekly InjectionObesity
Eli LillyTirzepatidePhase 3Weekly InjectionObesity
Novo NordiskRybelsus®2019Daily OralDiabetes
Novo NordiskSemaglutidePhase 3Daily OralObesity
Novo NordiskInsulin IcodecPhase 3Weekly InjectionDiabetes
Novo NordiskIcoSemaPhase 3Weekly InjectionDiabetes
Eli LillyTrulicity®2014Weekly InjectionDiabetes
Novo NordiskVictoza®2010Daily InjectionDiabetes
Novo NordiskSaxenda®2014Daily InjectionObesity
Selected FDA approved products and drug candidates in phase 3 for the treatment of either type 2 diabetes or obesity.

Phase 3

Eli Lilly has injected Tirzepatide for obesity in phase 3 (e.g. SURMOUNT-1 NCT04184622) and Novo Nordisk has oral Semaglutide for obesity in phase 3 (OASIS-1 NCT05035095).

Novo Nordisk had the long acting once-daily insulin Tresiba® approved in 2015 and now has the long acting once-weekly Insulin Icodec in phase 3. Novo Nordisk also has a combination drug of Semaglutide and Insulin Icodec – IcoSema – in phase 3; comparison with Insulin Icodec (COMBINE-1 NCT05352815), Semaglutide (COMBINE-1 NCT05259033) and Insulin Glargine + Insulin Aspart (COMBINE-3 NCT05013229).

Phase 2

Both companies have various candidates in phase 2 for the treatment of type 2 diabetes and obesity:

Eli Lilly – LY3437943 GGG (GIP/GLP-1/Glucagon) Tri-Agonist for the treatment of diabetes (NCT04867785) and obesity (NCT04881760).

Eli Lilly – LY3502970 (GLP-1 Receptor Non-peptide Agonist) for diabetes (NCT05048719) and obesity (NCT05051579).

Novo Nordisk – FDC Sema – OW GIP – A combination of semaglutide and novel GIP (NNC0480-0389?) intended for once-weekly treatment of diabetesNCT05144984

Novo Nordisk – CagriSema in T2D – A combination of amylin analogue cagrilintide and GLP-1 analogue semaglutide intended for once-weekly treatment of diabetesNCT04982575

Novo Nordisk – PYY 1875 – A novel analogue of the appetite-regulating hormone, PYY (NNC0165-1875), intended for once-weekly treatment of obesityNCT04969939

Conclusions

The FDA will likely grant approval to Eli Lilly of injected Tirzepatide for obesity and to Novo Nordisk of oral Semaglutide for obesity, so the big difference between Novo Nordisk and Eli Lilly in the GLP-1 space going forward is that Novo Nordisk will be able to offer tablets, and Eli Lilly will only be able to offer subcutaneous administration. Going forward Novo Nordisk continues to look like the stronger competitor in both the diabetes and obesity arena, despite Eli Lilly securing FDA approval of Mounjaro® and also having SGLT2 and DPP4 anti-diabetic products.

Revenue from different GLP1 drugs in different geographies.
Revenue from different diabetes drug classes in different geographies across companies.

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