EU Pharma: ADA Obesity KOL meeting – EU takeaways

Research evidence excerpt

EU Pharma: ADA Obesity KOL meeting – EU takeaways

didn't view the FDA's Phase 4 hepatic-safety

requirement for Foundayo as an issue with experience from statins, citing that "liver

abnormalities were observed in almost every (statin)". Our KOL expected oral agents to

further expand market with GLP-1 naive patients with advantages in cost of goods, storage

and distribution, expanded access with lower price especially in self-pay market.

•• Monthly or longer interval dosing wasn't an area of big excitement, given adherence

issues. VF viewed the monthly dosing regimen (being tested by PFE with Metsera monthly

GLP1) as untested in the commercial setting. Historically, monthly products sold poorly in

adjacent fields due to adherence issue. Semi-annual siRNA was noted to face the buy-and-bill

problem, which he considers a flawed model for physicians. He noted a greater preference

among cardiologists vs. endocrinologists, and cited PCSK9 siRNA (Leqvio) as the precedent.

•• GLP-1 seen to have a class effect on liver fat (or MASH); diagnosis is the bottleneck. VF

viewed BI/ZEAL survodutide GLP1/Glucagon data as underwhelming with a high placebo

effect in the MASLD readout. The MASH-focused strategy was also seen as challenging. VF

would use such a product preferentially for patients with liver fat and ideally additive to

Rezdiffra if the liver data are genuinely strong. Our KOL uses Rezdiffra (THR-B) for ~10 patients

and noted the gating issue across MASH is diagnosis, for example, the FibroScan is hard to

reimburse.

•• Body composition monitoring was seen as critical though testing is not reimbursed

yet, muscle preservation remains a focus especially for men. Our KOL noted that DEXA

scans are reimbursed for osteoporosis while not being reimbursed for body composition

reads.