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Eli Lilly set the tone for his REWIND study on the cardiovascular consequences of the drug Trulicity for Trulicity, a key part of his defense against Novo Nordisk's competing drug.
Lilly revealed Last November, the GLP-1 agonist baseline data, once a week, was positive and over the weekend, at the meeting of the American Diabetes Association, presented the detailed data from the test, which was also published in The lancet.
Overall, there was a 12% reduction in major cardiovascular events (MACE) in middle-aged and elderly people with type 2 diabetes – including cardiovascular deaths, myocardial infarction non-fatal or non-fatal strokes – as well as 15% decline in the development of kidney disease compared to placebo after more than five years of follow-up.
According to Lilly, the results are significant because they are among the first to show that a type 2 diabetes drug can have a beneficial effect on MACE in patients with or without established cardiovascular disease, a "more" population representative of people with type 2 diabetes, usually seen in clinical practice. "
The big question is whether the size of the improvements is sufficient to counter the challenge thrown to Trulicity by Ozonic (semaglutide), a GLP-1 agonist once a week, launched once a week and launched last year.
Ozempic has experienced rapid growth since its launch and reported DKK 1.4 billion ($ 211 million) in the first quarter of this year. Trulicity, which has reported $ 880 million over the same period, still has a long way to go, but Novo Nordisk says its market share in the US is now 30% and that it claims about 50% of new prescriptions.
To date, Trulicity's growth stems largely from its once-weekly administration, which has proven to be a popular alternative to the daily agonists of GLP-1, such as the former drug Victoza (liraglutide ) from Novo Nordisk. At present, competition in the market is considerably more intense.
With all the warnings relating to the comparison of tests of different designs, Novo Nordisk will be able to indicate its study on cardiovascular outcomes – SUSTAIN-6 – which revealed a reduced MACE risk of 26 % over placebo over a two-year period. We are already starting to flout data showing that Ozempic seems to be superior Trulicity to maintain glucose control once added to the background treatment with metformin.
Lilly points out that the Ozempic data come from a population with mostly established cardiovascular disease, rather than a "real" patient spectrum, and include a much longer follow-up period. More than 46% of the participants were women and less than one-third had had cardiovascular disease.
REWIND's results have been submitted to US and European regulators for review, the report says.
At the same time, Novo Nordisk has presented to ADA new data on its next challenger for a share of the GLP-1 agonist market, a oral formulation semaglutide, which is currently under rapid review by the FDA and is expected to be finalized in September.
The results of the Phase 3 trials of the drug presented at the ADA showed that Lilly and Boehringer Ingelheim, an oral SGLT2 inhibitor (empagliflozin) equivalent to glucose control, were equivalent to oral equagliflozin, administered once. per day, at time intervals of six and 12 months.
Novo Nordisk has data in hand regarding a cardiovascular risk reduction claim for oral semaglutide, and has also submitted it to the FDA as part of a standard review that is expected to be completed early next year.
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