Key Developments from 2024 and 2025 in the Hyperlipidemia Drug Market
Description: This article summarizes the most significant clinical trial results, regulatory actions, and strategic announcements that have shaped the market from late 2024 through 2025.
The period spanning late 2024 through 2025 has been marked by several significant milestones that are reshaping the competitive landscape of the Hyperlipidemia Drug Market. One of the most impactful was the positive outcome of Amgen's Phase 3 VESALIUS-CV trial for Repatha (evolocumab) in October 2025. This landmark study demonstrated the PCSK9 inhibitor's ability to reduce major adverse cardiovascular events in primary prevention, which is individuals without a prior heart attack or stroke, paving the way for wider clinical use.
On the pipeline front, March 2025 saw Eli Lilly & Company announce promising Phase 2 clinical data for lepodisiran, a small interference RNA (siRNA) therapy targeting Lipoprotein(a) [Lp(a)]. The drug demonstrated an outstanding reduction of approximately 94% in Lp(a) levels, positioning it as a potential breakthrough treatment for a high-risk population currently underserved by existing therapies. This success highlights the continued investment in RNA-based therapeutics.
In terms of strategic activity, the market witnessed key collaborations and acquisitions, such as Pfizer's October 2024 partnership with Sarepta Therapeutics to develop a new class of lipid-lowering agents based on gene-editing technology. Additionally, Sanofi S.A. started a new combination therapy with Praluent (Alirocumab) in November 2024 for patients with mixed hyperlipidemia. These developments underscore a strategic industry focus on combining potent mechanisms, leveraging genetic science, and enhancing treatment convenience.
<hr>
FAQs
What was a major regulatory development in 2024? In March 2024, the FDA granted approval for Praluent (Alirocumab) injections for use in pediatric patients with high cholesterol, allowing for earlier intervention in managing LDL-C levels.
What innovation is Merck & Co. contributing to the PCSK9 class? Merck's oral PCSK9 inhibitor, MK-0616, achieved late-stage success in 2025, offering a potential oral alternative to the current injectable PCSK9 biologics, which could significantly improve patient accessibility and adherence.