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The July 2023 cardiology month in review features a Class I recall from the FDA, the latest recommendation statement from the USPSTF, and an update on 3 agents in the pipeline.
Following June 2023, which featured 3 regulatory updates and a deep dive into a primary prevention subgroup from the CLEAR Outcomes trial, the cardiology community set a high bar for itself entering July 2023. Although it did not the same flurry of FDA news, the field of cardiology saw its fair share of relevant and impactful updates.
In this month in review, the editorial team of HCPLive Cardiology highlights our most popular stories and content from July 2023, which includes clinical trial updates on agents in the pipeline, new USPSTF guidelines, and an FDA recall of Impella pumps.
On July 27, 2023, the US Food and Drug Administration delivered an email announcing a Class I recall of all left-sided Impella blood pumps. The recall, which was launched by Abiomed, cites inadequate Instructions for Use as it pertains to precautions to take when treating patients who have undergone TAVR. The FDA underlined the product is not being removed from market and does not need to be returned.
According to the FDA, the potential damage to the motor’s impeller blades may occur if an Impella interacts with TAVR and this could result in pump failure. As of July 27, 2023, the FDA had received more than 30 complaints, including 4 deaths, related to the issue.
A new study from investigators in Italy is raising a red flag related to potential impact of alcohol consumption on blood pressure. With many conflicting reports on the effects of alcohol on cardiovascular and overall health, this study, which was an analysis of 7 international studies of healthy adults, suggest daily alcohol consumption was associated with increases in systolic and diastolic blood pressure over time. With more than 19,000 participants from the 7 trials, investigators purport finding “no beneficial effects” of low levels of alcohol consumption during the 5.3 median years of follow-up included in the study.
On July 18, 2023, the US Preventive Services Task Force released their latest recommendation statement, which addressed the benefits and harms of screening for lipid disorders in asymptomatic children and adolescents.
The organization’s first update on the subject in more than 6 years, the latest recommendation from the USPSTF reaffirms the organization’s 2016, with the group concluding the current evidence was insufficient to balance the benefits and harms of screen for this patient population.
Never ones to rest on their laurels, the field of cardiology is known for its continued pace towards advancement and optimal care. This was on display throughout July 2023, with clinical trial updates number of arenas. In this portion of our month in review, we highlight new data an RNA interference agent being examined for hypertension and a pair of agents in development for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM).
An RNA interference agent from Alnylam Pharmaceuticals Inc., zilebesiran made waves twice in late July, with the publishing of phase 1 data in the New England Journal of Medicine and, later, with the announcement of a strategic agreement with Roche to develop and commercialize the agent.
The trial published in NEJM was a phase 1 first-in-human, dose-escalation. Results of the study, which was designed as a 5-part trial, support advancement to phase 2 trials, with data providing insight into the tolerability and efficacy of the agent in people with hypertension.
The aforementioned trial of zilebesiran was not the only phase 1 data published in NEJM during the latter half of July. Joining the trial was a phase 1 trial of NI006, a recombinant human antibody designed to deplete amyloid deposits in ATTR-CM from Neurimmune AG.
A first-in-human investigation, the phase 1 trial consisting of 2 parts, the NI006-101 trial was designed with a 4-month, double-blind, placebo-controlled, international, multicenter, combined single-ascending-dose phase and an 8-month, multiple-ascending-dose, randomized clinical trial with an open-label extension phase. Results of the trial suggest use of NI006 was associated with possible reductions in NT-proBNP and troponin T levels without the presence of drug-related serious adverse events at 12 months among patients with wild-type or variant ATTR cardiomyopathy and chronic heart failure.
On July 17, 2023, BridgeBio Pharma announced positive 30-month data from their phase 3 study of acoramidis in ATTR-CM, clearing the way for regulatory submission of a New Drug Application (NDA) before the end of 2023. An investigational, next-generation, orally administered, highly potent, small molecule stabilizer of transthyretin, 30-month results of the ATTRibute-CM trial suggest use was associated with statistically significant improvement in the study’s primary endpoint and an 81% on-treatment survival rate, which correlated to an absolute risk reduction for mortality of 6.43% and a relative risk reduction of 25% compared to placebo therapy.