A look at the pending PDUFA of tirzepatide and how it may compare to Rybelsus (semaglutide) and the Type 2 diabetes space as a wholeTicker(s): LLY, NVO
Institution: Harvard Medical School
- Personally cares for ~1,000 patients, 500 of them are Type 1 and 500 of them are Type 2
- Confirmed "Very Familiar" with the inTANDEM trial and sotagliflozin literature
- Co-Investigator of two landmark studies: the national Diabetes Prevention Program and the Look AHEAD (Action for Health in Diabetes) Study
Q1. Please describe your specialty and details about your practice
How many Type 2 diabetes patients do you treat
Please describe the standard of care in the treatment of Type 2 Diabetes.
Which drugs are used and in which order, and what are the preferred agents?
Where do GLP-1 agonists fit into this picture?
What drives the decision when choosing between different GLP-1 agonists, and what is the preferred formulation of semaglutide (Ozempic/Rybelsus) among the subQ and oral options?
Do you anticipate an evolution in the standard of care where guidelines will recommend GLP-1 agonists first line and the field will move away from Metformin as a first line treatment?
How might this affect prescribing among specialists?
How might this affect prescribing in the primary care setting?
Do you intend to use GLP-1's more as a first line option?
How has the reimbursement situation been with GLP-1 prescribing, and what kind of challenges might Tirzepatide face entering this marketplace?
Where would you want to see Tirzepatide priced and what pricing would make it most competitive and most able to gain share in this market?
Given that Tirzepatid is a dual agonist of GIP and GLP-1, in terms of the biology/physiology are there known benefits from GIP agonism that you expect are contributing to efficacy with this product?
Will this contribute to long term cardiovascular benefit in the ongoing CVOTs or could it mitigate to some degree the benefits from GLP-1 agonism which are already established?
What is your high level view of Tirzepatide safety and efficacy from its "SURPASS" phase 3 trials, and do you expect it to be approved at its approaching PDUFA date in May?
Is the efficacy differentiated, and would this become your preferred agent?
In the SURPASS 2 Trial comparing multiple doses of Tirzepatide to Semaglutide 1mg, do you find the superiority on A1c, weight reduction, and blood pressure convincing?
Was Semaglutide dosed suboptimally in the trial and therefore the superiority is in doubt, or does the totality of data suggest Tirzepatide is reaching a new level of efficacy in the space not seen before?
27-46% on Tirzepatide reached <5.7% A1c, vs 19% on semaglutide.
With same caveat above on optimal dosing, is this a convincing difference?
This is described in NEJM as "without increasing hypoglycemia" but 1.7% at the highest dose (15mg) Tirzepatide experienced hypoglycemia. Is this concerning or acceptable?
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