UK Centres of Excellence planned for rare disease

by JoelLane 29. February 2012 12:13

Pf NHS News Three NHS Centres of Excellence for the diagnosis and treatment of Behçet’s Disease (BD), a rare immune disorder, will be commissioned in April 2012.

The centres, located at Bart’s and the London Hospital, Birmingham City Hospital and Aintree University Hospital in Liverpool, will centralise drug budgets and co-ordinate treatment for the condition nationwide.

While fewer than 1,000 people in the UK suffer from BD, the new centres will provide a model for the treatment of rare diseases through multi-drug therapy.

The contract follows a successful bid by the Behçet’s Syndrome Society together with multi-disciplinary clinical teams from each hospital.

Behçet’s (pronounced Betjets) Disease is a chronic condition caused by disturbances in the immune system. Common symptoms include headaches, mouth and genital ulcers, eye inflammation and arthritis.

Symptomatic BD-related therapies include analgesics, topical steroids, NSAIDs and beta-blockers. Systemic therapies include immunosuppressants and cytotoxic drugs, as well as new biologic agents.

The centralisation of the drug budget for BD patients will ensure timely access to high-cost drugs. The centres will also provide a platform for research into new therapies for the condition.

Professor Robert J. Moots, who will lead the Liverpool centre, commented: “As cure is currently not possible, the strategy for treating BD today is to suppress disease activity as much as possible without the patients paying the price of unacceptable side-effects. This means the doctor choosing from a wide armamentarium of drugs, to tailor therapy at the right time to the right person.

“It is essential that such treatment is led by a specialist with expertise not only in BD, but also in the delivery of such medications – and often, the best care is provided by a team of specialists who are each able to bring their particular expertise with the patient at the centre.”

EMA reviews NSAIDs safety

by emma 24. October 2011 13:30

Pf Industry News

The EMA has started a new review of the cardiovascular safety of non-selective NSAIDS (non-steroidal anti-inflammatory drugs).

The CHMP’s previous opinion of NSAIDs in 2006 was positive, but a small possibility of an increased risk of thrombotic events such as heart attack or stroke could not be excluded, particularly involving high doses and long-term treatment with NSAIDs.

The CHMP will update its opinion in light of recently published evidence from the independent research project Safety Of non-Steroidal anti-inflammatory drugs (SOS) funded by the European Commission.

NSAIDS have been subject to several European reviews in relation to gastrointestinal and cardiovascular safety and the occurrence of serious skin reactions since the CHMP’s 2006 opinion.

It will review the results thoroughly, together with other available clinical research data, to distinguish the need to update the CHMP’s 2006 opinion.

Painkillers linked to heart attack and stroke

by emma 3. October 2011 17:13

Pf product news

Popular painkillers or non-steroidal, anti-flammatory drugs (NSAIDs) can increase the risk of heart attack or stroke by a third, a study has found.

Researchers from the NHS, Hull York Medical School (HYMS), and the Institute for Clinical Evaluative Sciences in Canada found that patients with heart problems who used NSAIDs, including diclofenac and indomethacin, had a significantly higher risk of serious cardiovascular events compared to patients who did not.

Dr Patricia McGettigan, lead researcher of the study at HYMS said: “NSAIDs provide pain relief for millions of patients with chronic inflammatory disorders. The cardiovascular risk is well described but often overlooked.”

Even OTC drugs such as diclofenac were linked to serious cardiovascular risks, however, other common NSAIDs, including naproxen and low doses of ibuprofen do not appear to increase any risks.

The team of researchers based its results after reviewing 51 large scale studies of NSAIDs conducted in Europe, USA, Canada and Australia.

Dr McGettigan commented: “In choosing which one of the many available NSAIDs to use, patients and doctors would benefit from knowledge of the balance between benefit and harm for individual NSAIDs.”

Many people use NSAIDs in both OTC and prescription form for pain relief and for their anti-inflammatory effects to treat pains and aches.

In 2010, GPs prescribed 17 million NSAIDs in England alone, accounting for one in three people in the country. Of these, nearly 6 million were for diclofenac, 5 million were for ibuprofen and 3 million for naproxen, all of which can be bought without prescription.

PLx appoints new chairman

by emma 9. August 2011 14:12

Pf industry news

PLx Pharma has appointed Michael J. Valentino as Chairman of its Board of Directors.

Mr Valentino has previously worked for Adams Respiratory Therapeutics, Novartis AG and Warner Lambert.

Ron Zimmerman, President and CEO of PLx Pharma, said: “Mike’s exceptional industry and commercialisation experience with a range of OTC and Rx drug products will be extremely valuable”.

PLx is a pharmaceutical company developing gastrointestinal (GI) safer formulations of proven non-steroidal anti-inflammatory drugs (NSAIDs) including aspirin, ibuprofen and indomethacin for over-the-counter and prescription markets.

European approval for childhood arthritis drug

by emma 3. August 2011 13:37

Pf product news

Roche’s RoActemra has been approved in Europe for the treatment of Systemic Juvenile Idiopathic Arthritis (sJIA).

The medicine is intended to treat patients two years of age and older who have responded inadequately to previous therapy with NSAIDS and systemic corticosteroids.

RoActemra is known as Actemra outside of Europe can be prescribed alone or in combination with methotrexate.

Hal Barron, Chief Medical Officer and Head of Global Product Development at Roche, stated: “RoACTEMRA is the first and only biological treatment to demonstrate significant efficacy in this patient population and offers physicians a new option for this extremely difficult to treat disease.”

sJIA is the rarest form of Juvenile Idiopathic Arthritis (JIA), also known as Juvenile Rheumatoid Arthritis (JRA). The disease affects about 10-20% of children with JIA, with the peak age of developing sJIA being between 18 months and two years of age, although the disease can persist into adulthood. 

Roche is a biotechnology company with focus on pharmaceuticals and diagnostics. The organisation manufactures medicines to be used in areas of oncology, virology, inflammation, metabolism and CNS.

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