Amgen Announces FDA Advisory Committee Meeting to Review Repatha (Evolocumab) as a Treatment for High Cholesterol
Amgen has announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the FDA will review data supporting the Company's Biologics License Application (BLA) for Repatha (evolocumab) for the treatment of high cholesterol at a meeting on 10 June 2015. Repatha is an investigational fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove low-density lipoprotein cholesterol (LDL-C), or "bad" cholesterol, from the blood.
"There is a critical need for additional treatment options for high-risk patients who are unable to control their high cholesterol with currently available therapies," said Sean E. Harper, executive vice president of R&D at Amgen. "We look forward to discussing the efficacy and safety data from our clinical program with the members of the Committee."
The EMDAC will review results from clinical trials in support of the BLA for Repatha, which is based on data from approximately 6,800 patients, including more than 4,500 patients with high cholesterol in 10 Phase III trials. The Phase 3 studies evaluated the safety and efficacy of Repatha in patients with elevated cholesterol, including patients on statins with or without other lipid-lowering therapies; patients who cannot tolerate statins; patients with heterozygous familial hypercholesterolemia (HeFH) and patients with homozygous familial hypercholesterolemia (HoFH), a rare and serious genetic disorder.
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of 27 August 2015, for the Repatha BLA.
Related News
-
News Pharmapack Awards 2024 Patient-Centric Design Award Winner – Dr Ferrer BioPharma
The 2024 Pharmapack Awards celebrated the best in innovation and design for the pharmaceutical packaging and drug delivery industry on January 24, 2024. -
News Women in Pharma: Minding the Gap at Pharmapack 2024
2024 marks the first year Pharmapack will host a Diversity track dedicated to bridging the gap within the pharmaceutical packaging and drug delivery sector. The track includes a panel discussion on 'Enabling Diversity in the Workplace,' focused... -
News Pharmapack Awards 2024 - Celebrating Packaging and Drug Delivery Innovation
The 2024 Pharmapack Innovation Awards ceremony celebrated the best in pharmaceutical packaging and drug delivery innovation at all levels. The awards were held on January 24, 2024 at the Paris Expo Porte de Versailles. -
News 2024 Pharma Industry Trends Outlook: Collaboration, Market Maturity, and Digital Futures
The annual CPHI Online 2024 Pharma Trends Outlook, in partnership with Arvato Systems, identifies 12 key industry trends shaping the life sciences industry in the coming year. -
News New Novo Nordisk AI hub for drug discovery to open in London, UK
Danish pharmaceutical giant Novo Nordisk will be opening an AI-based research facility in the heart of London to advance drug discovery operations. -
News BioNTech to begin mRNA vaccine manufacturing in Rwanda by 2025
German biotechnology company BioNTech has stated their intentions to begin production at their mRNA vaccine factory in Rwanda by 2025, which will mark the first foreign mRNA vaccine manufacturing site on the continent of Africa. -
News Women in Pharma: Looking back on 2023 and moving forward to 2024
In this monthly series, we interview women from across the pharmaceutical industry and supply chain to discuss the importance of gender diversity in healthcare, the workplace, and beyond. -
News CPHI Barcelona 2023: Partnering for Success – Managing Outsourcing Relationships to Optimise Manufacturing Operations
During CPHI Barcelona 2023, insightful content sessions offered attendees the chance to explore trending topics with expert speakers and panellists. Here, we summarise what the pharma industry and supply chain are talking about the most.
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