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.