FDA approves Lilly’s Zepbound for obstructive sleep apnea
Lilly’s stock was up slightly in after-hours trading.
Lilly’s stock was up slightly in after-hours trading.
After a stunning 703% run-up in price over the past five years, shares of Eli Lilly and Co. have been on a roller-coaster ride since September.
The FDA had previously said Lilly’s drugs were out of shortage and that making copies must cease in October. Compounders sued, causing the FDA to pause enforcement while it reevaluated its decision.
David Ricks told a lunch audience at the Economic Club of Washington, D.C., that Zepbound could quickly become the most popular drug in the 148-year-old company’s history.
Vivek Ramaswamy owns about $670 million in shares of Roivant Sciences, which is pursuing studies for three drugs that could land before the FDA during Donald Trump’s second term.
TV remains the drug industry’s primary advertising format, with more than $4 billion spent in the past year, led by blockbuster drugs like weight-loss treatment Wegovy, according to ispot.tv, which tracks ads.
The Indianapolis-based drugmaker missed expectations on sales of two popular drugs, diabetes treatment Mounjaro and weight-loss treatment Zepbound, which it attributed to inventory decreases in the wholesaler channel.
Britian’s National Institute for Health and Care Excellence said more evidence was needed to prove Kisunla’s worth. Lilly says a year’s worth of treatment is $32,000.
The product, called Credelio Quattro, is designed to protect against fleas, ticks, heartworms, roundworms, hookworms and three different species of tapeworms.
The plaintiffs allege that the shortage of Lilly’s drugs isn’t actually over, and that the agency’s decision deprives patients of important medicines by restricting compounding.
Lilly has been making the case since August that its tirzepatide-based drugs are now “commercially available,” which the FDA agreed on. But the agency warned that patients and prescribers might still experience “localized supply disruptions.”
The the Swiss drugmaker will face off in the obesity area with leaders Novo Nordisk A/S and Indianapolis-based Eli Lilly and Co.
Recurrent shortages, shifting insurance coverage, indecision and a lack of guidance about side effects and dosing have led to challenges for some patients prescribed Mounjaro, Ozempic, Zepbound or Wegovy.
The Indianapolis-based drugmaker filed a suit in federal court this month, challenging the U.S. Food and Drug Administration’s ruling that the company’s experimental obesity treatment not a biological product.
The letter is the latest sign that the battle between the brand-name drug manufacturers and the companies that make and sell the compounded versions has intensified.
The expansion projects will boost production of medicines for Alzheimer’s disease, diabetes and obesity.
Lucas Montarce, who has been with Lilly since 2001 and most recently served as president for its Spain, Portugal and Greece operations, is now the company’s CFO and executive vice president.
Last year’s inspection numbers were down almost 40% from the pre-pandemic period, when the FDA averaged about 4,300 annual inspections.
Lilly and rival Novo Nordisk have been battling the emerging industry making copies of their top-selling diabetes and weight-loss drugs, a situation without modern precedent.
Fishers-based Flexware Integration LLC, a fast-growing IT services provider, has acquired Castle Hill Technologies LLC, a North Carolina-based company that provides engineering services to the pharmaceutical industry.