The FDA advisory committee’s split vote leaves Jardiance’s CV death reduction label addition in the balance but the drug is still set to grow.
By Louisa Joseph, Analyst
5 July 2016
This Research Wire is excerpted from our Chronic Heart Failure: Marketed Profiles report.
The FDA’s Endocrinologic and Metabolic advisory committee narrowly voted to include reduced risk of cardiovascular (CV) death on Jardiance’s (empagliflozin; Eli Lilly/Boehringer Ingelheim) label on 28th June 2016. The vote was almost evenly split at 12-11 in favor of the label addition (Eli Lilly, 2016). Although the tight vote makes it difficult to predict the FDA’s final decision, Jardiance is still likely to benefit from the positive outcome of its CV safety study, EMPA-REG OUTCOME. An addition to Jardiance’s label would allow sales teams to directly promote the CV benefit of Jardiance in order to drive uptake and gain preferential formulary inclusion. Should this not be forthcoming, Datamonitor Healthcare expects data from EMPA-REG OUTCOMES to be added to the drug’s label given the impressive reductions in CV death. This combined with the high-profile journal publication on the results of the EMPA-REG OUTCOME trial is expected to continue to drive uptake.
Committee members on both sides of the vote agreed that Jardiance demonstrated an impressive reduction in CV related death. However, nearly half of the committee members were concerned about the significance of the data, as CV related death was not included as a primary outcome in the trial design. Experts on the other side of the vote acknowledged this concern but also expressed the opinion that the robust reduction in CV death outweighed the doubts they had about statistical significance (BMT, 2016). Datamonitor Healthcare expects increased uptake of Jardiance regardless of the FDA’s decision. This is likely to occur predominantly in patients that are at increased risk for CV related death, who are expected to gain the greatest benefit from Jardiance. Jardiance demonstrated an overall reduction in MACE, however the reduction was driven almost entirely by decreased instances of CV related death. This was the rationale behind Eli Lily and Boehringer Ingelheim’s decision to apply to have reduction in CV related death added to Jardiance’s label.
Eli Lilly (2016) FDA Advisory Committee recommends approval of Jardiance® (empagliflozin) for cardiovascular indication in 12-11 vote. Available from: https://investor.lilly.com/releasedetail.cfm?ReleaseID=977470 [Accessed 29 June 2016].
This Research Wire is excerpted from Chronic Heart Failure: Marketed Profiles.
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