Twice a year versus twice a month?
When it comes to the dosing of a drug, that’s a major difference. And it's why analysts with GlobalData are predicting big things for Novartis’ newly approved cholesterol drug Leqvio.
Thanks to its convenience edge, the med could reap $2.5 billion by 2027, GlobalData says. The data analytics and consulting firm sees Leqvio surpassing PCSK9 rivals Repatha from Amgen and Praluent from Sanofi and Regeneron, which are expected to ring up sales of $2.2 billion and $716 million in 2027, respectively, GlobalData says.
The bright expectations are courtesy of the ease of administration for Leqvio, which requires two doctor’s visits a year. Repatha and Praluent are taken at home by self-injection twice a month, although both also have a once-monthly dosing option.
Both of the older drugs have come up short of initial commercial expectations because of high launch prices and payer restrictions. Both companies have slashed their list prices from around $14,000 at launch to an annual cost of $5,850. After its approval, Novartis recently priced Leqvio at $6,500 per year before rebates and discounts.
“Despite this barrier, Leqvio’s administration convenience puts the drug in a better position,” Valentina Gburick, GlobalData’s senior director of cardiovascular and metabolic diseases, gender health and ophthalmology, said in the report. “Furthermore, Leqvio’s reimbursement will be routed through the medical benefit pathway, meaning the majority of patients would be eligible for Leqvio with no co-pays at launch.”
Repatha won FDA approval to lower bad cholesterol in 2015 and two years later gained a nod for preventing heart attack and stroke. The med generated $1.12 billion last year, a 26% increase from 2020.
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As for Praluent, that med won its initial FDA nod in 2015 and followed with a heart attack and stroke nod in 2019. The Sanofi and Regeneron drug pulled in $388 million last year.
Novartis is awaiting preliminary data from a trial measuring Leqvio’s cardiovascular benefits. The study will not be complete until 2026, so a potential approval there is a long way off.
Still, Novartis—because of its experience in the cardio market and physicians’ general trust in heart failure drug Entresto—has a chance to gain a competitive edge in the lowering of cholesterol, provided it has gotten the pricing right, Gburcik says. This will become clear “in the next few months,” she said.
Although the drugs are from the same class, Leqvio works differently, Gburcik noted. While Repatha and Praluent are monoclonal antibodies that inhibit PCSK9 activity, Leqvio degrades the “mRNA molocules used to translate genetic instructions into proteins,” she said.
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With several of Novartis' key drugs reaching their patent life—including leukemia med Tasigna, eye medicine Lucentis and asthma drug Xolair—the company is counting heavily on its new treatments. Among the company's other growth drivers are immunology drug Cosentyx, Kesimpta for multiple sclerosis, Kisqali for breast cancer and gene therapy Zolgensma.