In addition to significantly lowering LDL-C by up to 50.8%, Apo B by up to 29.8%, and non-HDL-C by up to 44.4%, in ROSE2 obicetrapib 10 mg monotherapy compared to placebo significantly decreased total LDL-P, small LDL-P, and sdLDL-C by 54.8%, 92.7%, and 30.9%, respectively. A pooled analysis of Lp(a) demonstrated a placebo-corrected reduction of 57.1%. Obicetrapib plus ezetimibe also significantly reduced total LDL-P (-72.1%), small LDL-P (-95.4%), and sdLDL-C (-44.4%), beyond its significant effects on LDL-C (-63.4%), non-HDL-C (-55.6%), and Apo B (-34.4%). Obicetrapib had an adverse event profile similar to placebo, and it was nearly completely eliminated from circulation within 4 weeks after dosing.
Although the mechanisms are incompletely understood, evidence is mounting for a benefit of CETP inhibition on reducing the risks of type 2 diabetes mellitus and dementia, and most recent data point to an improvement of high-density lipoprotein structure and functionality.
Recent evidence suggests favorable associations between CETP inhibition and reduced risks of several other conditions including age-related macular degeneration, chronic kidney disease, and septicemia.
The increased prevalence of CETP loss-of-function gene variants in centenarians, as well as the potential benefits of CETP inhibition in ASCVD and other conditions associated with aging, suggest lifelong low levels of CETP activity may promote longevity.
Honestly, if you are controlling your lipids through other meds, you can probably wait the 1-3 years for it to get approved.
Waiting for it to be generically available in India might take the longest. Do we know how long it takes from FDA approval until India makes a generic of a drug? 6 months? A year? Years???
I donât think itâs so straightforward. Bempedoic Acid is an outlier. I think the BA patent already expired in India, or there is some other reason why it wasnât granted. In general, India also follows patent terms before generics can be authorized. So, itâs not as though ever drug will launch as a generic in India right away. The difference is that India doesnât bend over completely for pharma companies and wonât entertain frivolous patent extensions and is perhaps more reserved in granting patents to begin with. Semaglutideâs patent expires in India and China in 2026. Itâll be interesting to see how the market shapes up for that.
You may be right â but the consumer may get lucky. GlobalData, which describes itself as âa leading data and analytics company,â noted in 2022 that âIn February 2020, the FDA approved Esperionâs bempedoic acid under the brand name Nexletol and EMA approved it in April 2020 under the brand name Nilemdo.â âZydus Lifesciences launched a first-in-class oral, non-statin lipid-lowering drug, bempedoic acid, under the brand name Bemdac, for the first time in India in May 2022â and âWithin eight days of the launch by Zydus Lifesciences, three companies Sun Pharma, Akum Drugs & Pharmaceuticals Ltd and Cadila Pharma have already announced plans to launch bempedoic acid in India.â " Notably, there are no generics available for bempedoic acid in the US or Europe." âIndian players can launch bempedoic acid in India as there is no valid product patent in India." âFurthermore, none of the Indian players have any partnership with Esperion for bempedoic acid.â âBempedoic acid has a huge potential in India, based on the overall dyslipidemia patient population and the patients with uncontrolled LDL-c levels.â
Consideration of dementia related traits indicated that lower CETP concentrations were associated higher total brain volume (0.04 per standard deviation, 95%CI 0.02; 0.06), lower risk of LBD (OR 0.81, 95%CI 0.74; 0.89) and Parkinsonâs dementia risk (OR 0.26, 95%CI 0.14; 0.48).
That PD OR is incredible
Do you know who that other team is? (Or were you just saying âhopefully will be replicatedâ?)