Amarin released disappointing post hoc data from a sub-study of the REDUCE-IT trial, showing that its fish oil-derived Vascepa had little impact on serum biomarkers.
Commercial-stage pharmaceuticals company Amarin Corporation released disappointing post hoc data from a sub-study of the REDUCE-IT trial, showing that its fish oil-derived Vascepa (icosapent ethyl) had little impact on serum biomarkers for atherosclerotic disease in statin-treated patients.
The findings, published Tuesday in the journal Circulation, revealed that over 12 and 24 months of follow-up, patients allocated to the Vascepa arm saw very little changes in the serum concentrations of homocysteine, lipoprotein(a), oxidized low-density lipoprotein cholesterol, interleukin-6, lipoprotein-associated phospholipase A2, high-sensitivity C-reactive protein and interleukin-1β.
During this time, however, patients assigned to the mineral oil comparator group saw a marked rise in these biomarkers, mainly accounting for the end-of-study between-group treatment differences.
Though the paper’s authors indicate that the impact of these findings on the observed risk reductions in the overall REDUCE-IT trial remains uncertain, some experts have already raised questions about the drug’s efficacy.
Conducted over seven years and across 11 countries, REDUCE-IT evaluated the efficacy and safety of Vascepa in more than 8,000 adult patients whose serum levels of LDL-C had been controlled using statins. Though participants also had background cardiovascular risk factors, REDUCE-IT found that Vascepa could reduce the risk of major adverse cardiovascular events by 25%.
“While exploratory biomarker sub-analyses are interesting scientifically, what is most clear and important clinically are the cardiovascular outcomes results seen in the REDUCE-IT trial overall,” Nabil Abadir, MB. CH.B., chief medical officer of Amarin, said in a statement. “As we know, the REDUCE-IT trial demonstrated the clear risk reduction benefits of icosapent ethyl in reducing cardiovascular events among patients most at risk for cardiovascular disease, especially those with prior cardiovascular events such as heart attack or coronary revascularization procedures.”
Amarin’s stocks took a hit for the third session in a row after the disappointing findings went live. This comes after the company announced a series of job cuts in early June, reducing its pre-pandemic U.S. headcount by some 90% in order to save $100 million in operational costs.
Joining Amarin is Las Vegas-based Secura Bio. The company’s drug Copiktra (duvelisib) was flagged yesterday by the U.S. Food and Drug Administration to possibly increase the risk of death.
The regulatory body approved Copiktra in 2018 for the treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma in adults who had previously received and failed at least two lines of therapy. At the time, information regarding the drug’s safety and death risk was sparse. Five-year follow-up data for the phase III DUO trial revealed the elevated death risk with Copiktra as compared with the monoclonal body ofatumumab.
“We are notifying the public of these risks and are continuing to evaluate the safety of Copiktra,” the FDA wrote in its Drug Safety Communication. “We plan to hold a future public meeting to discuss the findings from the clinical trial and whether Copiktra should continue to be prescribed for patients.” The FDA’s recent advisory also noted that Copiktra is also possibly linked to a higher risk of serious side effects such as infections, intestinal and lung inflammation, skin reactions, and diarrhea.
DUO is a randomized, open-label trial that enrolled over 300 patients who either failed or were refractory to prior therapy. The trial was designed to evaluate the safety and efficacy of Copiktra, which blocks signals that enable cancer cells to multiply.
The FDA will provide more details once available. In the meantime, patients are advised to refer to their healthcare professionals for questions and concerns.
