Single-patient access to Lilly obesity drug draws scrutiny
Stat reported that a 79-year-old patient received early access to retatrutide, prompting questions about whether the patient is Donald Trump.
By Hana Yoshida · Markets Reporter
3 min read
A lone 79-year-old patient has been cleared to receive Eli Lilly’s experimental weight-loss drug retatrutide before approval, Stat News reported, prompting questions about who received the unusual access and why. The case matters because retatrutide is one of the most closely watched obesity drugs in development, while early access is generally reserved for patients with serious conditions who lack good alternatives.
According to Stat, the patient was granted access through the Food and Drug Administration’s expanded access program, often called compassionate use. The program allows some patients to receive investigational treatments outside clinical trials when they have serious or life-threatening diseases or conditions and cannot get satisfactory approved therapy.
Stat reported that the request was submitted in April by Ranganath Muniyappa, a senior clinician at the National Institutes of Health. The patient was described as having refractory obesity, obstructive sleep apnea and pulmonary hypertension, or high blood pressure in the lungs.
The patient had spent about a year taking tirzepatide, according to Stat’s sources. Tirzepatide, another Lilly drug, acts on GLP-1 and GIP hormone pathways, but the patient had only moderate weight loss, Stat reported.
Retatrutide is designed to act on three hormone pathways: GLP-1, GIP and glucagon. Lilly has been testing it in late-stage trials for obesity, diabetes, sleep apnea and other conditions.
In May, Lilly released Phase 3 data showing that patients with obesity who did not have diabetes lost 28% of their body weight after 80 weeks on retatrutide. The result is in the range of weight loss associated with bariatric surgery, according to the report.
Stat reported that the patient was not advised to undergo bariatric surgery because of age and medical conditions. The report said it was not clear whether the patient would have qualified for a clinical trial, or whether retatrutide is likely to help people who did not lose substantial weight on tirzepatide.
The case drew added scrutiny because President Donald Trump was 79 when the access request was made; he turned 80 on June 14. Stat asked the White House and the Department of Health and Human Services whether Trump was the patient and whether he has obstructive sleep apnea or pulmonary hypertension, conditions not listed in a memo from his most recent medical evaluation.
White House spokesperson Kush Desai did not answer Stat’s question and referred the outlet to HHS. HHS spokesperson Emily Hilliard did not directly deny that Trump was the patient, according to Stat.
Hilliard told Stat that the FDA supports expanded access programs for patients with serious or life-threatening conditions when no comparable or satisfactory approved therapies are available. She said requests are reviewed case by case under clinical circumstances and applicable law and regulation.
Stat also reported that the public listing for the expanded access case contains little information compared with typical notices. Richard Klein, who helped start the FDA expanded access program in the 1980s, told Stat that the listing would be hard to find without knowing the drug name and said the entry did not make clear what the access was for.
More than a dozen experts told Stat it is highly unusual for a company to provide expanded access to a drug for common conditions to only one patient rather than a defined group. Lilly spokesperson Misty Fuller did not answer Stat’s specific questions and said the company makes such decisions under applicable regulations. Muniyappa did not respond to Stat’s questions.
This story draws on original reporting from Ars Technica.