Althera Pharmaceuticals, a maker of cardiovascular medications, is in the FDA crosshairs for its flagship cholesterol oral delivery drug Roszet.
The drug, which combines two standard cholesterol treatments in one pill, is under the FDA Office of Prescription Drug Promotion’s spyglass for promotional claims around the product’s efficacy and risk.
Among other things, the FDA argues that these claims aren’t supported by the research the Morristown, New Jersey-based company cites.
“These violations are especially concerning from a public health perspective because the promotional communication creates a misleading impression regarding the safety and effectiveness of Roszet, which is a drug with multiple serious and potentially life-threatening risks,” said the FDA in the undated letter.
Launched in 2021, Roszet offers a one-two punch comprising the statins rosuvastatin and ezetimibe, a cholesterol absorption inhibitor. The pill was approved for adults for the treatment of elevated low-density lipoprotein cholesterol (LDL-C) in adult patients with primary non-familial hyperlipidemia and homozygous familial hypercholesterolemia, alone or as an adjunct to other LDL-C lowering therapies.
While statins are the first line of treatment for moderating serum cholesterol, studies show that mating statins with absorption inhibitors confers significant benefits. How significant? The federal watchdog says Roszet’s claims on this score are spurious, not least because the research wasn’t Roszet’s.
The FDA chaffs at Althera‘s promotional claims of LDL-C reductions at specific doses: 59% at 5 mg, 64% at 10 mg, 66% at 20 mg, and—as the brand trumpets on its consumer splash page—up to 72% at 40 mg, and says company claims about “total” LDL-C reductions are not the findings of any Roszet studies.
“Rather,” argues the administration, “The analysis used to generate these percentages combines the results of two separate and unrelated studies.” One of these evaluates rosuvastatin alone, and the other weighs the benefits of ezetimibe added to ongoing statin therapy in patients with primary hyperlipidemia, coronary heart disease or multiple cardio risk factors who hadn’t met their target LDL-C goals.
The letter goes on to note that the company, in effect, sliced and diced the numbers by combining results of the two, neither of which evaluated Roszet’s combo of rosuvastatin and ezetimibe, and that, further, the studies differ in patient population, type and dose of statins and duration of tests.
So, while the FDA says the research Roszet cites does support the FDA’s finding of safety and efficacy with respect to labeled indication for reducing LDL-C in certain patients, the studies’ “multiple limitations” nix its value in supporting any broad claims about the drug helping patients achieve specific levels of LDL-C.
The FDA also zeroes in one example of what it calls misleading claims about a specific level of LDL-C (70 mg/dl) that, according to Roszet content, patients can achieve with just one pill daily.
The problem, per the FDA, is that the claim is based on studies for which that sub-70 mg/dl number was a secondary endpoint, and one of several endpoints in the studies, at that.“As the number of endpoints analyzed in a single study increases, the likelihood of making false conclusions about a drug’s effects with respect to one or more of these endpoints becomes a concern if there is not appropriate adjustment for multiplicity,” said the FDA.
Althera now has two weeks to reply to the letter and potentially will need to make changes to its promotion of the drug. The company says its second product, Ezetimibe/Atorvastatin tablets (AL-310), is approved in both U.S. and Europe and is expected to be available to patients next year.
This is just the third untitled letter from the FDA this year, with the other two for Eli Lilly’s promotion of diabetes med Trulicity and Bausch’s skin cream Duobrii.