Eli Lilly’s drug tirzepatide has been granted “fast track” status by the Food and Drug Administration, which suggests it could win approval to be prescribed as an obesity treatment as early as late 2023. The drug, which was already approved in May as a treatment for Type 2 diabetes under the name Mounjaro, has the potential to be a blockbuster, analysts have said. Last month, UBS estimated peak annual sales will reach $25 billion , which might eclipse sales of AbbVie’s rheumatoid arthritis treatment Humira, which currently holds the title of the “biggest drug ever.” Lilly said Thursday that it plans to start an application for FDA approval on a rolling basis by the tip of this 12 months, and may have results for its second phase-three clinical trial complete by the tip of April. Wells Fargo analyst Mohit Bansal said it could typically take the FDA between six and 10 months to review the information, however the expedited process could shave day off the review, as data from its earlier clinical trials and manufacturing information will be submitted before the Surmount-2 trial is accomplished. “We see high likelihood of a 6-month review making approval in 4Q’23 likely,” Bansal wrote in a research note. Morgan Stanley analyst Terence Flynn estimated a first-half 2024 launch of the product. Although this timing is consistent with what the corporate had previously outlined, there had been some anticipation that the method could move even faster based on the strong leads to the primary of the 2 phase-three clinical trials. On par with bariatric surgery The corporate’s Surmount-1 study had shown that patients lost between 16% and 22.5% of their body weight while taking the medication, which is far closer to the outcomes achieved by bariatric surgery. Greater than 40% of U.S. adults have obesity, in accordance with the Centers for Disease Control and Prevention , and its prevalence is predicted to rise in the longer term. Obesity puts people at greater risk for a bunch of other conditions and costs the U.S. nearly $173 billion every year, in 2019 dollars, the CDC said. In July, Morgan Stanley had said it expected the load loss market might be value greater than $50 billion by the tip of the last decade. Lilly shares were up barely Thursday on the news, however the stock has gained greater than 20% because the start of the 12 months. On Sept. 28, it hit a 52-week high of $341.70. In a research note, Morgan Stanley’s Flynn said any weakness in Lilly’s stock is a buying opportunity. He rates the stock as chubby and has a price goal of $412, which means roughly 24% upside from Wednesday’s close. More pressure on Novo Nordisk The timetable also turns up the warmth for Novo Nordisk’s competing treatment, Wegovy. Each drugs use glucagon-like peptide-1, or GLP-1, receptor agonists to slow gastric emptying, promote satiety and regulate blood sugar, but tirzepatide has a second incretin hormone, glucose-dependent insulinotropic polypeptide, or GIP. Wegovy has been shown to assist patients lose about 15% of their body weight on average, and the drug has been very talked-about. Nevertheless, sales have been constrained by manufacturing issues, which have limited its sales. As well as, the price of the drug, which is not all the time covered by medical insurance plans, also prevents some patients from taking it. Wegovy has an inventory price of about $1,300 a month. Read more UBS upgrades Eli Lilly to purchase, says it’s developing possibly ‘the largest drug ever’ Investors bet on obesity drugs before without much success. Why this next wave might be different Novo Nordisk shares were trading down lower than 1% on Thursday. The corporate’s stock is down nearly 6% 12 months up to now. Beyond its enormous potential as a treatment for diabetes, obesity and chubby, tirzepatide can also be being studied as a treatment for a spread of other conditions , similar to kidney disease, sleep apnea, non-alcoholic steatohepatitis, pre-diabetes and cardiovascular issues. Bank of America’s Geoff Meacham has estimated that the drug could reach as much as $100 billion in annual sales by 2035 if it were to win approval for these other illnesses. — CNBC’s Michael Bloom contributed to this story.
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