Merck receives Complete Response Letter from FDA for Zetia (ezetimibe) and Vytorin (ezetimibe and simvastatin)
The company is reviewing the letter and will determine next steps.
Merck (MSD) has announced that FDA has issued a Complete Response Letter regarding Merck's Supplemental New Drug Applications for Zetia and Vytorin for the reduction of the risk of cardiovascular events (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina, or need for revascularization) in patients with coronary heart disease. The applications were based on the results of IMPROVE-IT (IMProved Reduction of Outcomes: Vytorin Efficacy International Trial). Merck is reviewing the letter and will determine next steps.
Zetia and Vytorin are indicated for use along with a healthy diet to reduce elevated LDL cholesterol in patients with hyperlipidemia. The effect of Zetia on cardiovascular morbidity and mortality has not been determined. Vytorin contains two active ingredients: ezetimibe and simvastatin. No incremental benefit of Vytorin on cardiovascular morbidity and mortality over and above that demonstrated for simvastatin has been established.
Related News
-
News PSCI Welcomes Delpharm, Samsung Biologics, and Suven as First Supplier Partners
The pharmaceutical industry continues to evolve with an increasing focus on responsible sourcing, sustainability, and collaboration across the supply chain. Under a new model to recognise suppliers within the pharmaceutical and healthcare industry that... -
News Drug prices agreed upon as part of the US Inflation Reduction Act
The Inflation Reduction Act brought into constitution by the Biden administation in 2022, which proposed a drug price negotiation between the government and pharmaceutical companies, has reached it's first agreement. -
.png)
News Eisai Alzheimer’s drug authorised in UK but still faces obstacles
In partnership with BioArctic AB, pharmaceutical company Eisai has been granted Marketing Authorisation by the Medicines and Healthcare products Regulatory Agency (MHRA) for its Alzheimer’s disease drug product Leqembi. -
News Eli Lilly's weight loss drugs removed from the FDA's shortage list
The US FDA have recently updated their drug shortage list. The recently released list shows that all dosage forms of Eli Lilly's weight-loss drug Zepbound and their diabetes drug Mounjaro are now available. -
News Global advancements in the diagnosis and treatment of rare diseases: Rare Disease Day 2024
Rare Diseases Day is celebrated on the 29th February 2024 and represents the plight of rare disease patients to gain diagnosis and access to suitable treatment. -
News Pharmaceutical industry supports COP28 health stance in joint statement
As COP28 takes place over this week in Dubai, UAE, several bodies in the pharmaceutical and health industries have come together to announce support of key movements in sustainability in the sector, and to recognise sustainability as a health issue.&nb... -
News Biden backs Cold-War measures to shore-up medical supply chains
In a recent strategy to combat rising inflation and the cost of living crisis, President Joe Biden has invoked a Cold War-era act to increase investment in a selection of medicines and supplies. -
News CPHI Podcast Series: What does the changing US Pharma market mean for industry and patients alike?
In this week's episode of the CPHI Podcast Series Lucy Chard, Digital Editor for CPHI Online is joined by James Manser to discuss the political and market changes in the US pharma field.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance