Tag Archives: european medicines

Superbug drug given go ahead

A new drug that specifically targets hospital superbug Clostridium difficile while avoiding so-called “friendly” bacteria in the gut has been recommended by the European medicines supervisor.

It is hoped that Dificlir will improve the current treatment of the inflammation of the gut and severe diarrhoea caused by C. diff.

The European Medicines Agency (EMA) said the antibiotic should be authorised, a move they described as “a major step forward” in tackling the growing levels of resistance to available antibiotics across the European Union.

Infection with C. diff is a leading cause of disease in hospital, usually causing illness in patients who have been treated with other antibiotics, the EMA said.

Clostridium difficile

Clostridium difficile

But few acceptable treatments for C. diff are currently available, the agency added.

Because Dificlir targets C. diff specifically, its effect on other, beneficial bacteria in the gut is said to be minimal.


Dr Xavier Luria, the EMA’s head of safety and efficacy, said: “This is a promising step forward in the agency’s drive for addressing patients’ needs in infectious diseases.”

The drug is not currently licensed in the UK and is not used in British hospitals yet, the Medicines and Healthcare products Regulatory Agency said.

The European Commission will now make a decision on whether to authorise marketing of the drug.

New clot busting pill approved

A CLOT-busting pill that could prevent thousands of heart attack deaths has been approved for use on the NHS.

The 98p-a-day drug slashes the risk of a patient’s death after a heart attack by 21 per cent. It also reduces risk of subsequent cardiac arrest by 16 per cent.

Research has shown the drug, ticagrelor, works within 30 minutes and stops platelets in the blood forming into clots and causing heart attacks or strokes.

Experts say the treatment is the first advancement in the reduction of deaths in heart attack patients in 20 years.

Last year, the drug – brand name Brilinta – was licensed by the European Medicines Agency for use in combination with ­aspirin for adult patients who have suffered a heart attack or episode of unstable angina.

This meant it could be prescribed in the UK but at each individual primary care trust’s discretion and only specialist ­cardiologists could prescribe it to patients in hospital.

Blood clots

Blood clots

But NHS watchdog the National Institute for Health and Clinical Excellence has now ­rubber-stamped it. This means that within weeks ticagrelor has to be available across the country for patients from all doctors.

The drug, made by AstraZeneca, is the first in a new class of antiplatelet medicines to be given approval.

Around 162,000 people a year are admitted to hospital after suffering a heart attack. Of these, some will have another or die within six months.

In 2009, research showed that heart attack patients given ticagrelor were 21 per cent less likely to die compared with those given clopidogrel, the most commonly used anti-clotting medication.

Study results on more than 18,000 patients also showed the risk of further cardiac arrests dropped by 16 per cent for those taking the new pill.


Professor Kausik Ray, Professor of Cardiovascular Disease Prevention at St George’s Hospital NHS Trust Research Centre in London, described NICE’s recommendation as a “significant step forward for patients and doctors alike”.

Dr Carole Longson, NICE health technology evaluation director, said: “Although mortality from heart attack and other cardiovascular causes has declined, an increasingly ageing population, coupled with worrying trends in obesity and lifestyles involving less exercise, make management of acute coronary syndromes a continuing high priority.

“This draft guidance recognises the potential of ticagrelor in providing the NHS in England and Wales with another valuable tool to enable it to deal more effectively with the long-term management of heart problems.”

Professor Jeremy Pearson, associate medical director at the British Heart Foundation, said: “This is the beginning of a second generation of antiplatelet – or clot-busting – drugs.” He called ticagrelor “a welcome addition for heart patients, as it could help many avoid having second, more damaging heart attacks”.