Trulicity needs to pull it out of the bag with heart benefit claim

As Bernstein analysts put it, Rybelsus getting a cardiovascular risk-reduction claim on its label so soon was always a long shot. The FDA yesterday confirmed that it wanted results from Novo Nordisk’s long-term outcome study, Soul, before this accolade can be bestowed on the oral GLP-1 agonist. The agency did, however, allow data from Pioneer 6 on Rybelsus’s label; this shorter trial only showed non-inferiority to placebo, with a 21% reduction in Mace failing to hit statistical significance for superiority. Still, the new data should give Rybelsus a boost in the meantime – 21% is impressive compared with other outcome studies in this field. Meanwhile, once-weekly Ozempic – both agents contain the same active ingredient – got its risk-reduction claim thanks to the Sustain 6 result. Trulicity is up next, and Lilly could win an important differentiation if the FDA allows a risk-reduction claim in all type 2 diabetes patients, regardless of prior cardiovascular disease. Rewind was unique in that it recruited subjects without existing heart problems, though the results were far from clear-cut. If the decision goes Lilly’s way the company would be handed an advantage when it comes to payer negotiations, a crucial factor in this highly competitive space.

Major type 2 diabetes drugs and the cardiovascular claims
          Sales ($bn)
Product Mechanism Company CV risk reduction claim? Result and study  2020e 2024e
Trulicity Once-weekly GLP-1 agonist Lilly Decision due in H1'20 12% reduction in Mace in Rewind 4,797 6,634
Ozempic Once-weekly GLP-1 agonist Novo Nordisk Yes, FDA approved Jan 2020 26% reduction in Mace in Sustain 6 2,819 6,178
Jardiance SGLT2 inhibitor Boehringer Ingelheim/Lilly  Yes, FDA approved late 2016 14% reduction  in Mace in Empa-Reg 2,498 3,849
Rybelsus Oral, once-daily GLP-1 agonist Novo Nordisk Label describes non-inferiority to placebo 21% risk reduction in Pioneer 6; data from Soul outcome study due 2024. 377 3,305
Farxiga SGLT2 inhibitor Astrazeneca Claim for reduction of risk of hospitalisation for heart failure (hHF) 13% reduction in hHF in Declare-TIMI58 1,913 2,979
Victoza Once-daily GLP-1 agonist Novo Nordisk Yes, FDA approved 2017 13% reduction in Mace in Leader  2,947 1,129
Invokana SGLT2 inhibitor Johnson & Johnson Yes, on label since 2018 14% reduction in Mace in Canvas  668 588
Steglatro SGLT2 inhibitor Merck & Co No Vertis study should report later this year. 229 520
Source: EvaluatePharma,

Share This Article