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reimbursement based on the potential role/use of this medicine in the

context of its national health system.

Tackling the root causes of CVD can help to stem the development of

such potentially fatal conditions. Through initiatives such as reducing

cholesterol and investing in new collaborative research opportunities, as

exemplified in Horizon 2020, the healthiness of the vascular biology of

EU citizens can be preserved, whilst reaping the benefits to the Union’s

labour market and economy, helping to ensure a healthy European society.

diminishes its ability to remove LDL-cholesterol

from the blood.

The efficacy of Repatha as a lipid-lowering

agent was assessed in nine trials (about 5,500

people) in patients with hypercholesterolaemia

and mixed dyslipidaemia, and in two studies

(about 250 people) in patients with

homozygous familial hypercholesterolaemia.

Repatha reduced LDL-cholesterol for both

patient groups, though available evidence does

not yet allow the longer term benefits of

Repatha for patients in reducing heart disease

or death from heart disease to be determined.

Repatha safety

The Committee for Medicinal Products for Human

Use (CHMP) also looked at safety information

from patients with hypercholesterolaemia and

mixed dyslipidaemia; over 6,000 patients were

followed for at least six months, and over 1,100

patients followed for at least two years. The CHMP

considered that the safety profile of Repatha is

acceptable, with few patients discontinuing

treatment or showing serious adverse effects. A

similar safety profile was observed in patients with

homozygous familial hypercholesterolaemia, and

further data will be collected to assess the

implications of very low cholesterol levels.

The opinion adopted by the CHMP at its May

meeting is an intermediary step on Repatha’s

path to patient access. The CHMP opinion will

now be sent to the European Commission for

the adoption of a decision on an EU-wide

marketing authorisation. Once a marketing

authorisation has been granted, each EU

member state will take a decision on price and



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H O R I Z O N 2 0 2 0 P R O J E C T S : P O R TA L



C A N C E R & C A R D I O V A S C U L A R D I S E A S E

Cardiovascular co-fund

The European Commission has defined the research into CVD as

‘fragmented’, with few countries having ‘specific programmes

dedicated to this field of research’. The EU institution believes that the

issues regarding cardiovascular research ‘can only be met by effective

co-operation at transnational level, avoiding the duplication of efforts,

ensuring the availability of critical mass, efficiently using available

resources, exchanging knowledge, producing more significant results

of higher quality and impact, and sharing data and infrastructures.’

Consequently the Commission, as part of Horizon 2020, launched the

€5m ‘ERA-NET: Cardiovascular disease’ research topic, as part of the

wider €29m Health Co-ordination Activities call. The call, part of the

Societal Challenges pillar, ran from July 2014 to February 2015 and

the Commission sought proposals that ‘should co-ordinate national

and regional programmes for research in the area of cardiovascular

research by implementing a transnational call with EU co-funding

resulting in grants to third parties’.

In addition, research bids were pursued that ‘also aimed at the better

collaboration and alignment of national programmes and activities and

should provide concrete plans for decreasing fragmentation, for data

sharing, for addressing hurdles for effective co-ordination, for involving

stakeholders and relevant existing initiatives’.

As a result of the call, the Commission anticipates a number of

impacts, notably increasing ‘funding of transnational collaborative

research projects’; ‘streamlining national or regional practices in

organising research funding’; the ‘identification of common research

priorities and research needs, also taking into account developments

on the international level where relevant’; and the ‘sharing of data

and knowledge’.

Two proposals were submitted to the Commission for this research

topic and as part of the wider call, it is expected that the first grant

agreements will be signed by mid-September.

Preventing the build-

up of fatty deposits in

the artery can also

help to inhibit CVD