“Today’s announcement marks an important milestone for NewAmsterdam, the HeFH community, and CVD more broadly,” said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam. “Despite the widespread availability of lipid lowering therapies, CVD-related deaths have risen and patients remain above LDL-C targets. Patients and their doctors need additional options. We are very excited about the results from our BROOKLYN trial and believe they support obicetrapib’s potential to significantly reduce LDL-C in a challenging patient population, over a duration of one year. Adverse events and discontinuations due to side effects were similar to placebo, consistent with what was observed in Phase 2 studies. In the safety population, there was also no increase in blood pressure, nor any difference from placebo in liver enzymes, hs-CRP, or renal function. We look forward to building on these results with topline data from BROADWAY expected in the fourth quarter of 2024, and topline data from TANDEM expected in the first quarter of 2025.”
“The data announced today are another indication of obicetrapib’s potential to significantly reduce LDL-C in HeFH patients, a population already on multiple lipid-lowering therapies. I am incredibly encouraged by these results, which suggest that obicetrapib, if approved, has the potential to be a new oral option for a difficult-to-treat patient population and am excited to be a partner with the NewAmsterdam team on the remainder of the obicetrapib pivotal program,” said Stephen Nicholls, M.B.B.S., Ph.D., Director, Monash Victorian Heart Institute and Professor of Cardiology, Monash University.
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