ANN ARBOR, Mich. - The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued positive opinions for the label update of two cholesterol-lowering medications, bempedoic acid and a fixed-dose combination of bempedoic acid and ezetimibe, as announced by Daiichi Sankyo Europe GmbH and Esperion (NASDAQ:ESPR) Therapeutics, Inc.
The CHMP's backing is for the drugs to be used as treatments to reduce low-density lipoprotein cholesterol (LDL-C) and cardiovascular risk in adults. The current label for bempedoic acid allows its use as an adjunct to diet in combination with other lipid-lowering therapies for patients who are either unable to reach LDL-C goals with the highest tolerated statin dose or are statin-intolerant.
The proposed label update would extend its indication to adults at high risk for or with established atherosclerotic cardiovascular disease to lower LDL-C levels further and reduce cardiovascular risk.
Similarly, the bempedoic acid/ezetimibe fixed-dose combination tablet is approved for use alongside a diet and statin therapy in adults who cannot meet LDL-C goals with statins and ezetimibe alone, or for those who are statin-intolerant. The updated label would also include its use in patients at high risk for or with established atherosclerotic cardiovascular disease.
The positive opinions from the CHMP are based on data from the Phase 3 CLEAR Outcomes trial, which involved 13,970 patients across 32 countries and demonstrated a 13% relative risk reduction in major adverse cardiovascular events. These findings support the expanded use of the medications to address unmet needs in cardiovascular care and prevention.
Oliver Appelhans, Head of Europe Specialty Division at Daiichi Sankyo Europe, emphasized the milestone's importance in improving treatment outcomes and meeting the needs of cardiovascular care in Europe. Sheldon Koenig, President and CEO of Esperion, also expressed enthusiasm for the CHMP's opinion, highlighting the global benefit of the bempedoic acid franchise in managing cardiovascular risk for patients with elevated LDL-C.
The European Commission is expected to make a final decision on the label update authorization applications in the first half of 2024. The CHMP is responsible for reviewing medical product applications based on scientific and clinical merit, and its positive opinion is a significant step toward the final decision by the European Commission.
This news is based on a press release statement from Daiichi Sankyo Europe GmbH and Esperion Therapeutics, Inc.
InvestingPro Insights
As Esperion Therapeutics, Inc. anticipates a decision from the European Commission on their cholesterol-lowering medications, the company's financial data reflects a dynamic market position. According to InvestingPro data, Esperion's market capitalization stands at approximately $401.56 million, indicating a mid-sized biopharmaceutical company. Despite some challenges, there has been a significant revenue growth in the last twelve months as of Q4 2023, with an increase of 54.14%, and an even more impressive quarterly revenue growth of 71.38% in Q4 2023.
One InvestingPro Tip notes that analysts expect sales growth in the current year, which could be influenced by the potential label update and its subsequent impact on the market reach of Esperion's products. On the flip side, the company has been grappling with weak gross profit margins, as evidenced by a negative gross profit margin of -11.21% in the same period.
The stock performance of Esperion has also been a mixed bag, with a large price uptick of 113.09% over the last six months, yet a 1-month price total return of -19.77%, reflecting recent market volatility. The InvestingPro platform offers a deeper dive into Esperion's financials and stock performance, with PRONEWS24 providing an additional 10% off a yearly or biyearly Pro and Pro+ subscription for users seeking comprehensive analysis.
With the European Commission's decision pending, the company's future profitability and stock performance are of keen interest to investors. For those looking to stay ahead, there are 6 additional InvestingPro Tips available on the InvestingPro platform, offering valuable insights into Esperion's financial health and stock potential.
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