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 Women in Pharma: Moving beyond discussions and into best practice at CPHI Milan
In this second CPHI Milan special of our monthly series, we cover the key takeaways from the Diversity & Wellbeing track held on October 10, 2024. -
News AstraZeneca invests in AI collaboration for cancer drug trials
The British-Swedish pharmaceutical giant is partnering with biotechnology firm Immunai Inc to increase the efficiency of some cancer drug trials. -
News Ozempic and Wegovy prices questioned as Novo Nordisk faces US Senate hearing
The CEO of Novo Nordisk was grilled during a US Senate committee hearing on September 24, 2024, in which the exorbitant prices of the Danish company’s blockbuster drugs Ozempic and Wegovy were called into question. -
News The BIOSECURE Act: implications for the pharma supply chain
On September 9, 2024, the US House of Representatives voted to pass the bill titled the BIOSECURE Act (the Act), which lists several Chinese companies in the pharmaceutical supply chain. The Act will prohibit American companies from contracting or doin... -
News On Track at CPHI Milan: Thermo Fisher Scientific Track Sponsor interview
With CPHI Milan just around the corner, we sat down with some of the sponsors for this year’s conference tracks to discuss the most pressing topics in pharma. -
News CPHI Milan Speaker Spotlight: Pharma Manufacturing and Localisation in Africa
In the run-up to CPHI Milan, we sit down with some of the experts and thought-leaders speaking at this year’s conferences. -
News US BIOSECURE Act passed by US House of Representatives
The controversial act, which has already impacted several foreign companies operating in the US, was passed by the House of Representatives on September 9, 2024. It is now headed for the US Senate before it can be signed into law by President Joe Biden... -
News Eli Lilly licenses rheumatoid arthritis manufacturing in Africa
American pharmaceutical company Eli Lilly has signed a partnership with Egyptian organisation Eva Pharma to localise manufacturing of rheumatoid arthritis treatments in Africa.
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