One day after the U.S. Food and Drug Administration granted approval to Eli Lilly's orforglipron — the first oral GLP-1 receptor agonist pill cleared for chronic weight management — pharmacy benefit managers including CVS Caremark and Express Scripts moved Friday to classify the drug within their formulary review tracks, according to industry sources familiar with the process. The rapid response underscores the enormous commercial pressure building around the oral obesity drug market, which analysts at Morgan Stanley have projected could reach $150 billion globally by 2035.
Lilly's approval, backed by data from the ATTAIN clinical trial program showing meaningful weight reduction versus placebo without the need for injections, positions orforglipron as a potential market disruptor against Novo Nordisk's injectable semaglutide franchise. The pill formulation is widely expected to ease one of the primary access barriers patients have cited — needle aversion — and could substantially expand the treatable population. On Friday, several large employer health plan administrators publicly acknowledged they were accelerating internal coverage assessments.
The American Diabetes Association and the Obesity Medicine Association both issued statements Friday welcoming the approval and calling on insurers to avoid the coverage delays that have historically plagued GLP-1 therapies. The groups pointed to well-documented patterns in which prior authorization requirements and step-therapy mandates have blocked eligible patients from accessing approved medications for months or years after launch. Advocacy groups are pressing Congress to include oral GLP-1 coverage mandates in any forthcoming Medicare drug negotiation framework revisions.
Lilly shares extended gains in early Friday trading in New York, with the stock building on Thursday's post-approval rally. Analysts at Jefferies raised their 12-month price target on LLY, citing a faster-than-expected commercial ramp if payer negotiations conclude by mid-year. The company indicated it expects orforglipron to be available at U.S. retail pharmacies within weeks and that its manufacturing capacity, scaled up at facilities in Indiana and North Carolina, is sufficient to meet near-term demand.
Competitors are watching closely. Novo Nordisk, which has its own oral semaglutide tablet already on the market for type 2 diabetes, is expected to respond with updated positioning materials for Rybelsus and to accelerate its obesity-indication data filings. Pfizer, which abandoned its own oral GLP-1 candidate in 2024 following safety concerns, is not positioned to compete in the short term. The FDA approval of orforglipron marks a structural shift in the obesity treatment landscape, and Friday's payer and prescriber activity signals the commercial battle for the next generation of weight-loss medicine has formally begun.