El último tratamiento aprobado por la agencia regulatoria de fármacos en Estados Unidos, la FDA (Food and Drug Administration), no es nuevo. Al igual que ocurriera con Ozempic, Zepbound es un tratamiento contra la diabetes tipo 2 al que se le ha encontrado un nuevo uso: tratar la obesidad.
Un “nuevo” tratamiento… En los EE UU.
Y con esa función, la de luchar contra la obesidad, este tratamiento ha sido aprobado para su uso en los Estados Unidos. Zepbound se consolida así como la primera alternativa al fármaco que más ha dado de qué hablar desde el final de la pandemia, la semaglutida.
Zepbound.
Zepbound es el segundo nombre comercial que se ha dado a la tirzepatida, un compuesto desarrollado por la farmacéutica estadounidense Eli Lilly. Este compuesto también es la base del tratamiento contra la diabetes tipo 2 Mounjaro.
La FDA ahora ha aprobado el uso de este fármaco como tratamiento contra la obesidad y el sobrepeso.
Al igual que la semaglutida se comercializa con dos nombres, Ozempic (contra la diabetes) y Wegovy (para la pérdida de peso), la tirzepatida también estará presente en las farmacias estadounidenses bajo dos marcas, cada una orientada hacia un uso.
The FDA announced Wednesday that it has approved Eli Lilly's dual GIP and GLP-1 agonist tirzepatide for chronic weight management. Specifically, the weekly injectable medication will be marketed under the name Zepbound for adult patients with obesity, or for those who are overweight and have at least one weight-related condition.
"In light of increasing rates of both obesity and overweight in the US, today's approval addresses an unmet medical need," commented John Sharretts, director of the division of diabetes, lipid disorders and obesity in the FDA's Center for Drug Evaluation and Research. Tirzepatide has been cleared in the US as a treatment for diabetes since 2022 under the name Mounjaro.
The latest FDA decision was based on the Phase III SURMOUNT-1 and SURMOUNT-2 trials. Results from SURMOUNT-1, which included about 2500 participants, demonstrated that at the highest dose of 15mg, patients taking Zepbound lost an average 48 pounds, while at the lowest dose of 5mg, they shed 34 pounds on average. By contrast, participants who received placebo lost 7 pounds (for more, see ViewPoints: ADA 2023 – Tirzepatide study lead investigator says weight loss in type 2 diabetes and ensuing health benefits now a 'SURMOUNT'-able goal). List price of $1060 per month.
Eli Lilly said Zepbound should be available in the US by the end of the year in six doses, and carry a list price of about $1060 for a month's supply. Zepbound is the latest entrant into the field of GLP-1 agonists that already includes Novo Nordisk's semaglutide, which is marketed under the names Ozempic for diabetes and Wegovy for weight loss. Eli Lilly said the list price for its drug is about 20% lower than Wegovy.
Mike Mason, president of Eli Lilly's diabetes and obesity unit, stated that "broader access to [weight loss] medicines is critical, which is why Lilly is committed to working with healthcare, government and industry partners to ensure people who may benefit from Zepbound can access it."
According to the company, people who are commercially insured with coverage for Zepbound may be eligible to pay as low as $25 for a one-month or three-month prescription. Those who are commercially insured without coverage for Zepbound may be eligible to pay as low as $550 for a one-month prescription.
Eli Lilly reported earlier this month that Mounjaro garnered sales of $1.4 billion in the third quarter, up from $187.3 million in the prior year, and surpassing estimates by about $100 million. At the time, Bloomberg Intelligence analysts Sam Fazeli and John Murphy suggested that nothing comes close "to matching Mounjaro's importance to the company's near-term earnings."
All-time bestseller?
Zepbound's approval further establishes Eli Lilly as a formidable competitor to Novo Nordisk in the budding market for weight-loss treatments, with some analysts suggesting it could become one of the best-selling drugs in history. A FirstWord survey from July of 150 US physicians found that nearly all saw an increase in the number of patients seeking treatment for obesity over the past 12 months, although payer resistance had set up a notable barrier to access. FirstWord is working on a new physician's survey, with data to be released in the coming days.
Guggenheim analyst Seamus Fernandez said "we think [Zepbound] has a very, very strong shot at being the biggest [selling] drug of all time; obviously competing very closely with Novo Nordisk's Ozempic and Wegovy."
He noted that the GLP-1 category "for sure, will be the largest selling pharmaceutical market of all time," with the main challenge being reimbursement. "That being said, we do have some really important data coming this weekend from Novo Nordisk's…SELECT study, and that could really prove out…the benefits of [Wegovy] for patients who have high cardiovascular risk, so this may turn out to be more of a cardiovascular drug at the end of the day."
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