by IainBate
28. November 2012 12:25
Servier Laboratories’ heart-rate-lowing drug Procoralan (ivabradine) has been recommended as a treatment option for people with chronic heart failure in final guidance.
The treatment is recommended in patients with systolic dysfunction, who are in sinus rhythm and whose heart rate is 75 beats per minute or more and who have a have a left ventricular ejection fraction of 35% or less.
Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said “Procoralan has been shown to have a beneficial effect in reducing mortality and improving quality of life in people with some types of chronic heart failure.”
Heart failure affects approximately 900,000 people in the UK. The most common cause of heart failure is coronary heart disease.
The guidance also states that Procoralan should be taken in combination with standard therapy or when beta-blockers are contraindicated or not tolerated. Additionally, it must only be used after a stabilisation period of 4 weeks on optimised standard therapy.
“The Committee was mindful that there is robust evidence for the effectiveness of ACE inhibitors, beta-blockers and aldosterone antagonists that are used routinely in managing heart failure,” said Professor Longson.
“They concluded, therefore, that Procoralan could be considered a cost-effective use of NHS resources for treating chronic heart failure after optimal treatment with these drugs has been achieved and when patients are still symptomatic after receiving optimised initial therapies, or when beta-blockers are contraindicated or not tolerated by the patients.”
0f128877-f24c-4255-b7d0-8865f34649ff|0|.0
Tags: Servier Laboratories, Servier, Procoralan, ivabradine, chronic heart failure, NICE, NICE appraisal, NICE guidance, Professor Carole Longson, heart failure, ACE inhibitors, beta-blockers, aldosterone antagonists, NHS
Drugs
by IainBate
12. November 2012 14:21
Novartis expects its pharmaceutical division to have at least 14 ‘blockbuster’ products within the next five years.
The Group claims to lead the industry with the number of new approvals it has had globally since 2007 and expects the release of new products to be equally successful.
Joseph Jimenez, CEO of Novartis, said its “leading pipeline... positions us well for continued future growth.”
So far this year the company has received nine approvals or positive recommendations. It aims to build on this within the next 13 to 24 months with a further 11 pivotal trials, 11 filings and 10 regulatory decisions with various health authorities.
In addition, Novartis claims its pipeline boasts 139 projects in clinical development, including more than 73 New Molecular Entities across a multitude of disease areas.
It has highlighted compounds AIN457 from its oncology pipeline and LCZ696 and RLX030 for heart failure to create “significant newsflow” in the future. Also, Novartis claims compound QVA149 has the potential to become the “new standard of care for COPD”.
But within its oncology business is where the greatest growth is expected within the next five years. Novartis points towards its robust late-stage pipeline, which includes 13 new chemical entities and 19 new indications, to combat the upcoming patent expiry on Glivec.
These late-stage products are expected to contribute more than $1bn in sales by 2017, with Afinitor predicted to earn revenues of around $2bn in sales in advanced breast cancer alone in the same period.
358a310a-0a16-4b94-9ab8-8500897bd13e|0|.0
Tags: Novartis, Novartis Group, blockbuster, blockbuster brands, blockbuster drugs, Joseph Jimenez, health authorities, pipeline, Novartis pipeline, new molecular entities, clinical development, AIN457, oncology, heart failure, LCZ696, RLX030, QVA, COPD, Glivec, Afinitor
General
by IainBate
19. October 2012 15:04
NICE has confirmed its recommendation of Servier Laboratories’ Procoralan (ivabradine) for the treatment of chronic heart failure in final draft guidance.
The guidance states Procoralan should be taken in combination with standard therapy options or when beta-blockers are contraindicated or not tolerated – after a four week stabilisation period of standard therapy.
Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said the treatment “has been shown to have a beneficial effect in reducing mortality and improving quality of life in people with some types of chronic heart failure.”
Heart failure affects around 900,000 people in the UK. The most common cause of heart failure is coronary artery disease. The aim of treatment is to improve life expectancy and quality of life and to avoid patients being admitted to hospital.
“The Committee was mindful that there is robust evidence for the effectiveness of ACE inhibitors, beta-blockers and aldosterone antagonists that are used routinely in managing heart failure,” Professor Longson said.
“They concluded, therefore, that ivabradine could be considered a cost-effective use of NHS resources for treating chronic heart failure after optimal treatment with these drugs has been achieved and when patients are still symptomatic after receiving optimised initial therapies, or when beta-blockers are contraindicated or not tolerated by the patients.”
The recommendation means Procoralan can be supplied as an option for patients with systolic dysfunction, who are in sinus rhythm, whose heart rate is 75 beats per minute or more and who have a left ventricular ejection fraction of 35% or less.
5134f691-6aa4-4333-b8eb-bddd870b199b|1|4.0
Tags: NICE, NICE appraisal, NICE guidance, NICE recommendation, recommendation, final draft guidance, Servier Laboratories, Servier, Procoralan, ivabradine, chronic heart failure, chronic heart failure treatment, beta-blockers, Professor Carole Longson, heart failure, coronary artery disease, life expectancy, ACE inhibitors, aldosterone antagonists, NHS resources, systolic dysfunction, sinus rhythm, ventricular ejection fraction
News
by JoelLane
5. April 2012 15:57
Pfizer’s drug Inspra (eplerenone) has been licensed in the UK for treatment of patients with chronic heart failure (CHF).
The new indication follows evidence that Inspra can reduce the risk of death or hospitalisation from heart failure in the relevant patient group by 37%.
The drug, already licensed for treatment of heart failure after recent myocardial infarction, can now be used to improve CHF patients’ health at an earlier stage.
The addition of Inspra to standard therapy has been shown to offer an incremental cost of £3,534 per QALY gained – well below the £20,000 threshold accepted as good value by NICE.
CHF affects over 875,000 people in the UK, and one in three patients die within a year of diagnosis while the rest suffer frequent hospitalisations lasting an average of 11 days.
Inspra, a selective aldosterone antagonist and mineralocorticoid receptor antagonist, is now approved for use with standard therapy in adult patients with CHF and left ventricular systolic dysfunction (LVEF) up to 30%.
It was already indicated to treat patients with heart failure and LVEF up to 40% after recent myocardial infarction, alongside standard therapy.
The EMPHASIS-HF trial showed that adding Inspra to the patient’s regime reduced the risk of death from cardiovascular causes or a first hospitalisation for heart failure by 37%.
Professor Martin Cowie, Consultant Cardiologist at the Royal Brompton Hospital, London, commented: “Patients with chronic heart failure have a shorter life expectancy than patients with the most common types of cancer and can require frequent admission to hospital. These admissions account for the majority of the costs associated with treating CHF.
“New strategies that have the potential to reduce these costs, as well as extending patients’ lives, are particularly welcome during these times of increased financial pressure.”
d48e4f0d-ae02-4b08-8148-f3c8aee85c88|0|.0
Tags: Pfizer, Inspra, eplerenone, heart failure, chronic heart failure, CHF, hospitalisation, myocardial infarction, NICE, QALY, aldosterone antagonist, mineralocorticoid receptor antagonist, left ventricular systolic dysfunction, LVEF, EMPHASIS-HF, Professor Martin Cowie
News
by JoelLane
15. November 2011 15:04
Teva UK has launched two generic cardiac drugs in the UK: Valsartan tablets and capsules and Valsartan Hydrochlorothiazide (HCTZ) tablets.
Valsartan is a generic version of Novartis’ Diovan and Valsartan HCTZ of Novartis’ Co-Diovan.
Both drugs are indicated for treatment of heart failure, hypertension and recent myocardial infarction.
The two generics are available in the Teva 360 livery and can be purchased through Teva UK’s territory sales managers.
Kim Innes, Commercial Director at Teva, said: “As the leading generics company in the country and with the widest portfolio, Teva continues with strong product launches and patent expiries. We’ve already launched 19 products this year, including now eight day one patent expiries.”
Generic drugs, he said, can help pharmacies to increase their margins and keep costs down, and can save the NHS over £7 billion per year.
Teva UK is a leading UK pharmaceutical manufacturer with a presence in the generics, branded respiratory and hospital markets.
The company is part of the Israeli corporation Teva Pharmaceutical Industries, the world’s largest manufacturer of generic drugs.
bccdf787-b485-4457-903b-789211700618|0|.0
Tags: Teva UK, Teva, generic drugs, generics, Valsartan, Valsartan HCTZ, Novartis, Diovan, Co-Diovan, cardiac, heart failure, hypertension, myocardial infarction, Teva 360, Kim Innes
News
by emma
27. October 2011 16:11
Boston Scientific has launched the first iPad app to help healthcare professionals educate patients and carers about cardiovascular diseases and their treatment.
CardioTeach, available free of charge, provides an overview of normal heart function and the therapy options for atrial and ventricular arrhythmias, coronary artery disease, heart failure, heart rhythm disorders and peripheral vascular disease.
The app’s accessible content and graphics (see picture) help the clinician to explain specific conditions and procedures used to treat them, helping patients and their families to make informed choices.
Healthcare providers can also use CardioTeach to mark up anatomical illustrations with cardiac devices, add notes to a page or attach graphics to an e-mail for the patient or carer.
The patient can receive personalised cardiovascular education anywhere, helping them to make decisions and understand compliance and adherence requirements.
“Most medical device apps are designed to educate physicians on a specific product or therapy, said Leslie Saxon, Chief of Cardiovascular Medicine at the University of Southern California. “CardioTeach is unique because it lets clinicians better educate patients about their overall heart and vascular health and available treatment options.”
He added that CardioTeach gives patients “something they can reference after they leave my office and when thinking about or explaining what went on during the office visit,” as well as helping patients and their families “educate themselves prior to and between visits.”
Kenneth Stein, Boston Scientific’s Chief Medical Officer for Cardiac Rhythm Management, commented: “A recent study shows that one in five physicians use a tablet computer in their practice. Creating an app that enables healthcare professionals to use this technology to enhance communication with patients and caregivers is a logical extension of our efforts to empower patients with information about Boston Scientific’s therapies.”
Based in Massachusetts, USA, Boston Scientific is a global supplier of interventional medical devices.
7f6a20a9-14b2-4350-aa0f-6a03ea2ff788|0|.0
Tags: heart disease, app, application, iPad app, healthcare professionals, HCP, patients, cardiovascular, treatment, CardioTeach, cardio teach, heart, therapy, options, atrial, ventricular, arrhythmias, coronary artery, heart failure, heart rhythm disorders, peripheral vascular disease, illustrations, cardiac devices, med tech, medtech, medical devices, Leslie Saxon, health, Kenneth Stein, Boston Scientific, CMO, Chief Medical Officer, Massachusetts, US, USA, computer, tablet
Medtech News
by emma
25. October 2011 16:03
The CHMP has concluded that available evidence does not suggest a link between the angiotensin II receptor antagonists (ARBs) and the occurrence of new cancers after a review.
The Italian Medicines Agency requested a review following the publication of a meta-analysis which showed an increased risk of cancers compared with placebo and other heart medicines.
All available data was analysed by the Committee but it says that evidence was weak and raised concerns about the possibility of publication bias which may have been used in the meta-analysis.
ARBs are used for the treatment of hypertension and also for heart failure and kidney disease in those with type II diabetes.
As part of the review, the CHMP analysed data from large population-based studies and additional meta-analysis that did not have the same methodological problems as the original which raised concerns with the Italian regulatory body. But again, the CHMP confirmed the results did not show an increased risk of cancer.
The EMA has confirmed, along with all medicines, it will continuously monitor the safety of ARBs.
f281808c-7d8e-438d-9eda-d4c37f1ac674|0|.0
Tags: ARBs, cancer, no link, CHMP, evidence, angiotension 2 receptor antagonists, new cancers, Italian Medicines Agency, review, meta analysis, cancer risk, risk of cancers, placebo, heart medicines, heart treatment, heart drug, ema, hypertension, heart failure, kidney failure
News
by emma
5. September 2011 12:22
A new “electronic nose” is being developed to be used in routine screenings to “smell” out chronic heart failure (CHF).
The project’s results demonstrated that the technology is able to diagnose heart failure non-invasively with almost 90% accuracy.
Vasileios Kechagias, investigator of the study at University Hospital Jena, in Germany, said: “The early detection of CHF through periodical screening facilitates early treatment application”.
The system consists of three thick-film metal oxide-based gas sensors with heater elements, with each sensor tailored to react with different odorant molecular types. Reactions between the sensor and molecules are caused by oxygen on the heated sensor surface, altering the free charge carrier concentrations, which change conductivity in the metal oxide layer.
During the trial, the electronic nose assigned 126 patients to one of three groups: no heart failure, compensated and decompensated, with 90% accuracy. Compensated heart failure reacts to treatment, whereas the decompensated version of the condition has no treatment and can cause such conditions as infections, arrhythmias and electrolyte disturbances.
The sensor is simply placed on the arm much like a blood pressure monitor for three minutes at a time and then analyses for heart failure markers.
Heart failure is a common, costly and potentially deadly condition. Approximate 2% of adults suffer from the condition in developed countries, and increases to 6% in adults over the age of 65.
Scientists say more research is required, but ultimately hope to create a rapid, minimally invasive method to screen, diagnose and monitor compensated heart failure.
e77244e5-4cc9-4492-acd9-6f8ba2c0dfb0|0|.0
Tags: electronic nose, heart failure, CHF, chronic, screening, smell, sniff, detect, medical technology, medtech, med tech, med tech business, medtechbusiness, medtech business, medical news, health, healthcare, health care, technology, Vasileios Kechagias, Germany, diagnostics, diagnose, diagnosis, medical device, patient, compensated, decompensated, sensor, sense
Medtech News
by emma
2. September 2011 12:47
Leicester University has developed a new ‘Star Trek-style’ medical suite to help diagnose hospital patients with potentially serious diseases.
The £1 million ‘sick bay’ aims to assess patients more quickly, reducing the number of time-consuming and uncomfortable blood tests.
Professor Paul Monks, who helped develop the new facility, said: “We want to free doctors to actually treat patients and this technology enhances that ability.”
The medical bed assimilates the “ultimate non-invasive diagnostics”, which Star Trek fans will recognise, said Professor Monks.
“Dr McCoy in Star Trek had a tricorder that he waved over the patients to help diagnose diseases.”
Professor Tim Coats, a consultant at the hospital, said that the non-invasive technology uses one group of instruments to analyse the patient's breath, while a second group uses imaging originally intended for exploring the surface of Mars, while a third looks inside the body to measure blood flow.
The new high-tech facility has taken three years to develop, and promises to improve detection of serious diseases such as cancer, heart failure and infections. Professor Monks said: “We’ve shown that it can detect lung cancer quite early.”
Leicester Royal Infirmary plans to use the new equipment within two weeks in its Accident and Emergency department.
5aa580fa-73ea-4b57-86ee-c3262b1c9fbc|0|.0
Tags: innovation news, medtech, medical devices, medical technology, medtechbusiness, medtech business, medical, technology, health, healthcare, health care, Leicester, university, doctor, patient, Star Trek, sci-fi, space, medical suite, medical bed, sick bay, diagnostics, diagnose, diagnosis, hospital, royal infirmary, Paul Monks, facility, treatment, time consuming, disease, Tim Coats, machine, machinery, equipment, high tech, cancer, lung cancer, heart failure, infections
Medtech News
by emma
24. August 2011 16:59
NICE has failed to recommend Orencia (abatacept) as a second-line treatment for people with rheumatoid arthritis in final guidance.
Both NICE and Orencia’s manufacturer Bristol-Myers Squibb agreed the treatment would not be cost-effective when compared with several other recommended options.
Professor Carole Longson, Health Technology Evaluation Centre Director at NICE, says other recommended treatments offer better value for money as second-line options.
No appeals where received against the Final Appraisal Document released last month.
BMS had asked that Orencia be compared against another recommended option Remicade (infliximab), the only other recommended intravenous treatment options.
But NICE’s independent Appraisal Committee did not consider this to be a relevant comparison since the route of administration rarely determines which drug to prescribe.
The Committee also considered whether Orencia could be a cost-effective treatment option for those with a TNF inhibitor was contraindicated because of congestive heart failure. However, it did not consider it appropriate to provide a second recommendation given there was no evidence of how much clinical benefit the drug may provide in this group of people.
Humira, Enbrel, Cimzia, plus Remicade, and most recently Simponi have all been recommended as treatment options for second-line use on the NHS.
2fc49cc5-5734-4628-9c9f-6a6d9c77d46e|0|.0
Tags: Orencia, NICE, RA, abatacept, treatment, drug, medicine, medication, prescription, pharma, pharmafield, pharmaceuticals, pharma field, pharmaceuticalfield, pharmaceutical field, Pf, pharma news UK, rheumatoid arthritis, Bristol-Myers Squibb, BMS, cost-effective, Carole Longson, health, healthcare, health care, Remicade, infliximab, Appraisal Committee, TNF, inhibitor, heart failure, recommendation, NHS, Humira, Enbrel, Cimzia, Simponi
News