New Repatha dose delivery option receives positive CHMP opinion
The new automated mini doser with prefilled cartridge is a hands-free device designed to provide 420 mg of Repatha in a single injection per administration.
Amgen has announced that the Committee for Medicinal Products for Human Use (CHMP) of the EMA has adopted a positive opinion for an extension to the marketing authorization of a new 420 mg single-dose delivery option for Repatha (evolocumab). The new automated mini doser (AMD) with prefilled cartridge is a hands-free device designed to provide 420 mg of Repatha in a single injection per administration. Repatha is a human monoclonal antibody that blocks a protein called proprotein convertase subtilisin/kexin type 9 (PCSK9), which inhibits the body's natural system for eliminating 'bad' cholesterol (low-density lipoprotein cholesterol or LDL-C) from the blood.
If approved by the European Commission (EC), Repatha would be the first PCSK9 inhibitor in Europe with the option of a single monthly injection. Repatha was the first PCSK9 inhibitor to gain marketing authorization in Europe as an every-two-week or monthly dosing regimen on 17 July 2015. Repatha AMD will be available in Europe during 2017 depending on reimbursement requirements.
"We are pleased to advance our new dosing administration option and look forward to continuing our work with regulators to bring it to patients in Europe," said Sean E. Harper, executive vice president of Research and Development at Amgen. "The approval of this delivery system will provide an alternative for patients who need the additional LDL lowering that Repatha can provide and are seeking less frequent administration."
In Europe, Repatha is approved as an adjunct to diet for the treatment of high cholesterol in combination with statins or other lipid-lowering therapies in patients unable to control their LDL-C with maximum tolerated statin doses, or alone or in combination with other lipid-lowering therapies in patients who are statin intolerant or for whom a statin is contraindicated. Repatha is also approved in combination with other lipid-lowering agents in patients with homozygous familial hypercholesterolemia (age 12 and over). The effect of Repatha on cardiovascular morbidity and mortality has not yet been determined. Top-line results from the approximately 27,500-patient event-driven FOURIER study are anticipated in first quarter of 2017.
The CHMP positive opinion will now be reviewed by the EC and if granted, the marketing authorization will be extended to include the 420 mg single injection in the 28 member countries of the European Union (EU), as well as Iceland, Lichtenstein and Norway.
CHMP's positive opinion follows the FDA's approval of the single 420 mg monthly injection option on 11 July 2016, as the Repatha Pushtronex system (on-body infusor with prefilled cartridge).
More than 60% of high-risk patients in Europe are still unable to adequately lower their LDL-C levels with statins or other currently approved lipid-lowering agents. Among very high-risk patients, the percentage is increased to more than 80%. The health care cost of cardiovascular disease (CVD) in the EU is approximately €106 billion per year.
Related News
-
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. -
News Which 10 drugs are open to price negotiation with Medicare in the USA?
The Centres for Medicare & Medicaid Services, under the Biden administration in the USA, has released a list of the 10 drugs that will be open to price negotiations as part of the new legislation under the Inflation Reduction Act (IRA). -
News 10 Major Drug Approvals So Far in 2023
Last year, 37 novel drugs were approved by the FDA, this was a high number for such a category, and covered many fields including oncology, demonstrating how promising further research is, and how it is only continuing to build. To date, there are alre... -
News Novartis agrees for copies to be made of cancer drug to reach poorer countries
Novartis signs agreement with MPP to have generics of it's leukemia drug made so that it can be more easily distributed to the world's poorer countries. -
News CPHI Podcast Series: outsourcing and manufacturing trends
Listen to the CPHI Podcast Series this June to hear Gil Roth of the PBOA speak with Digital Editor Lucy Chard about the biggest trends and topics to watch in pharma outsourcing and manufacturing at the minute. -
News New WHO health emergency guidelines expect full transparency from Big Pharma
The WHO are proposing a new set of pandemic guidelines to set out how future global health crises should be handled.
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