NICE has recommended the use of Eliquis (apixaban) as a treatment option for the NHS for the prevention of stroke and systemic embolism in some people with non-valvular atrial fibrillation (AF) in final guidance.

The recommendation came after NICE’s Appraisal Committee concluded Eliquis was more clinical effective than warfarin in reducing stroke and systemic embolism.

Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said that patients would benefit using the convenient treatment “because it doesn’t require such regular monitoring and dose adjustments.”

Eliquis, which only received its license for this indication in November 2012, is an orally administered anticoagulant that helps prevent the blood from clotting.

AF is the most common irregular heart beat. People with the condition are at a higher risk of developing blood clots and subsequent stroke. Existing therapies, such as warfarin, substantially reduces the risk of stroke.

“Many people with the condition find it difficult to comply with the most commonly used antithrombotic, warfarin, because, among other things, its use requires regular monitoring of the blood’s clotting properties and dose adjustments which can cause disruption and inconvenience,” said Professor Longson.

“From the evidence submitted, the Committee concluded that Eliquis was more clinically effective than warfarin for the primary efficacy outcome of reducing stroke and systemic embolism. The Committee also noted that treatment with Eliquis resulted in fewer bleeding events than warfarin, including a reduced rate of intracranial bleeding. The Committee recognised that intracranial bleeding has a high mortality rate and a large impact on a person’s quality of life, and is the most feared bleeding outcome for people taking any type of anticoagulant.”

The Scottish Medicines Consortium (SMC) has accepted Eliquis (apixaban) for prevention of strokes in patients with atrial fibrillation (AF).

The drug, produced by Pfizer and Bristol-Myers Squibb (BMS), has also been provisionally recommended by NICE.

Its use in Scotland with AF patients over 40 is predicted to prevent nearly 1,000 strokes and over 300 deaths per year.

Following its EMA approval in November 2012, the SMC has accepted Eliquis for prevention of strokes in patients with non-valvular AF who have one or more risk factors (e.g. hypertension, diabetes).

Based on recent clinical trials, the SMC said Eliquis was superior to warfarin in preventing strokes and was associated with fewer major bleeds.

It also requires no monitoring and dosage adjustment, thus reducing the cost of treatment and avoiding the risks associated with poor monitoring.

AF affects over 60,000 people in Scotland over the age of 40. It causes a fivefold increase in stroke risk, resulting in 7% of all strokes. Strokes due to AF are more severe, and more likely to recur, than strokes with other causes.

Difficulties in setting the dosage of warfarin, the standard anticoagulant, mean that fewer than half of Scottish AF patients at high risk of stroke are receiving it.

Dr Derek Connelly, Consultant Cardiologist at the Royal Infirmary, Glasgow, said: “The SMC acceptance of apixaban is an important step forward for patients with atrial fibrillation in Scotland. The availability of a new treatment option that does not require [clotting time] monitoring may help decrease the impact atrial fibrillation has on the quality of life of patients, their families and carers.”

According to Amadou Diarra, BMS General Manager, UK and Ireland, the risk of stroke in patients with non-valvular AF is “a serious public health concern” that Eliquis can help to address.

NICE has provisionally recommended Eliquis in the same indication, with final guidance expected shortly.

The alliance between BMS and Pfizer to develop drugs against cardiovascular disease began in 2007.

The Atrial Fibrillation Association has welcomed NICE’s recommendation in final draft guidance of Eliquis (apixaban) for the prevention of stroke and systemic embolism in certain people with non-valvular atrial fibrillation.

NICE’s independent Appraisal Committee concluded the convenient drug was more clinically effective than warfarin and resulted in fewer bleeding events.

Trudie Lobban MBE, founder and CEO of the charity Atrial Fibrillation Association, said NICE’s decision is “excellent news for patients” with AF in England and Wales.

Eliquis’ recommendation follows the recent recommendations by the Institute of Xarelto (rivaroxaban) and Pradaxa (dabigatran etexilate) for the same indication.

“Having the choice of effective new treatments which do not require INR monitoring can help reduce the impact that atrial fibrillation has on patients, their families and carers,” said Trudie Lobban.

Final draft guidance states that Eliquis can be considered a treatment option on the NHS in accordance with its licensed indications if informed discussions about the risks and benefits of the drug compared with warfarin, Xarelto and Pradaxa are conducted.

Eliquis, which only received its license for the indication in November 2012, is co-marketed by Bristol-Myers Squibb and Pfizer.

Amadou Diarra, Vice-President, BMS UK and Ireland, said the “fast-tracked recommendation” by NICE highlights the value of the drug as a cost-effective treatment. “We look forward to working with the NHS and other partners to ensure that, where clinically appropriate, patients are provided with rapid access to apixaban, which has been shown to prevent strokes, reduce bleeds and be potentially life-saving compared to the current standard of care, warfarin.”

A new drug for stroke prevention that offers a safer and more effective alternative to warfarin has been launched in the UK.

Eliquis (apixaban) from BMS and Pfizer is available for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) and one or more risk factors such as diabetes or advanced age.

Whereas patients treated with warfarin risk serious side-effects and need frequent dosage adjustment, Eliquis is taken (in tablet form) in one of two approved doses.

AF affects 1.2 million people and causes 12,500 strokes every year in the UK.

Clinical trials have shown that Eliquis is more effective than warfarin in preventing strokes and causes less bleeding, as well as presenting less challenge in terms of monitoring.

The ARISTOTLE trial evaluated apixaban versus warfarin in 18,201 patients with non-valvular AF who were suitable for warfarin. Professor John McMurray of the Institute of Cardiovascular & Medical Sciences, University of Glasgow, said that in the study “apixaban has demonstrated superiority in the reduction of stroke and systemic embolism over warfarin together with a significant reduction in major bleeding.”

In addition, he noted, “apixaban was better tolerated than warfarin, with fewer people stopping treatment.”

Trudie Lobban, CEO of the Atrial Fibrillation Association, added: “Patients being treated with warfarin have to undergo regular blood tests. Having the choice of effective new treatments which do not require monitoring provides the option to tailor therapy to the individual patient.

“This could also help to reduce the burden on the NHS to monitor INR and the associated impact on patients, their families and carers.”

BMS developed Eliquis, and since 2007 has worked in partnership with Pfizer to promote and sell the drug.

A new drug for stroke prevention that offers a safer and more effective alternative to warfarin has been launched in the UK.

Eliquis (apixaban) from Bristol-Myers Squibb (BMS) and Pfizer is available for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) and one or more risk factors such as diabetes or advanced age.

Whereas patients treated with warfarin risk serious side-effects and need frequent dosage adjustment, Eliquis is taken (in tablet form) in one of two approved doses.

AF affects 1.2 million people and causes 12,500 strokes every year in the UK.

Clinical trials have shown that Eliquis is more effective than warfarin in preventing strokes and causes less bleeding, as well as presenting less challenge in terms of monitoring.

The ARISTOTLE trial evaluated apixaban versus warfarin in 18,201 patients with non-valvular AF who were suitable for warfarin. Professor John McMurray of the Institute of Cardiovascular & Medical Sciences, University of Glasgow, said that in the study “apixaban has demonstrated superiority in the reduction of stroke and systemic embolism over warfarin together with a significant reduction in major bleeding.”

In addition, he noted, “apixaban was better tolerated than warfarin, with fewer people stopping treatment.”

Trudie Lobban, CEO of the Atrial Fibrillation Association, added: “Patients being treated with warfarin have to undergo regular blood tests. Having the choice of effective new treatments which do not require monitoring provides the option to tailor therapy to the individual patient.

“This could also help to reduce the burden on the NHS to monitor INR and the associated impact on patients, their families and carers.”

BMS developed Eliquis, and since 2007 has worked in partnership with Pfizer to promote and sell the drug.

Bristol-Myers Squibb’s anti-platelet therapy Plavix (clopidogrel) has become the latest blockbuster to lose patent protection in the US.

A mainstay of heart disease treatment since 1997, Plavix faces immediate generic competition from Cardinal Health.

BMS, who markets Plavix in partnership with Sanofi, has said it will cease promoting the drug immediately following patent expiry.

Used together with aspirin, Plavix is the standard blood-thinning therapy for people who have suffered a heart attack.

The product earned BMS $7.1bn in 2011, a third of the company’s revenue.

BMS has decided not to follow the example of Pfizer, who promoted Lipitor extensively for six months after its US patent expiry, because the usual six-month exclusivity to one generic supplier will not apply.

The reason is that the first authorised supplier of generic clopidogrel, Apotex, forfeited its exclusivity period due to unlicensed sales in 2006.

As a result, seven companies have already received tentative approval to sell generic clopidogrel in the US. Cardinal Health plans a next-day launch. A spokesman for Sun Pharmaceutical Industries said the company would lose no time: “I would not be surprised if there was a stopwatch involved.”

BMS’s 2011 annual report predicted “a rapid, precipitous and material decline in Plavix net sales” following expiry of its US patent.

The company has developed a new blood-thinning drug, Eliquis, in partnership with Pfizer. Its FDA approval for stroke prevention is expected in June.

The FDA has delayed making a decision on whether to approve the use of Eliquis (apixaban) for the prevention of stroke and systemic embolism in patients with atrial fibrillation.

Further data supplied by Pfizer and Bristol-Myers Squibb on patient trials after the original application will take an additional three months to review, the Agency has said.

Pfizer and BMS said in a joint statement they will continue to work closely with FDA during the review period.

Eliquis is not yet approved in any country for the prevention of stroke and systemic embolism in patients with atrial fibrillation.

It faces competition from Boehringer’s Pradaxa (dabigatran) and J&J’s Xarelto (rivaroxaban) for the indication.

Industry analysts predict all three have the potential to become ‘blockbuster’ brands as doctors and patients search for an alternative to warfarin.

Eliquis was approved in May 2011 by the European Union as a treatment option for the prevention of blood clots in patients who have undergone hip or knee replacement surgery.

BernsteinResearch analyst Dr Timothy Anderson forecasts total sales of Eliquis to reach $395 million this year, rising to $2.5 billion in 2015 and $3.7 billion by 2020.

Pfizer, the world’s largest pharmaceutical company, has declared financial results for 2011 indicating that its new products largely compensated for its loss of exclusivity on Lipitor and other ‘blockbuster’ drugs.

The company declared a full-year revenue increase of 1% for 2011, reflecting an operational decline of only 2% ($1.6bn) despite losing $5bn of its former market share through patent expiry.

The results were described by Pfizer Chairman Ian Read (pictured) as showing the company’s “new direction and focus” with a strong pipeline and a more “results-driven” R&D programme.

Pfizer’s full-year revenues for 2011 were $67.4bn compared to 2010’s $67.1bn, reflecting an operational decline of $1.6bn. Its US revenues were $26.9bn, down 7% from 2010. Its international revenues were $40.5 billion, 6% above the 2010 figure, reflecting 1% operational growth and a 5% positive impact of foreign exchange. Pfizer’s international revenues represented 60% of the total in 2011, compared with 57% in 2010.

The company’s Primary Care unit saw growth in sales of Celebrex, Lyrica, Pristiq and Spiriva balancing losses from patent expiries: Lipitor and Caduet in the US in November 2011, Lipitor in other developed markets over 2010, and Aricept in the US in November 2010. These losses of exclusivity cost the unit $775m (13%) relative to the last quarter of 2010.

The Specialty Care unit saw growth in Enbrel in developed markets and Prevenar in Japan. In the US, revenues from Prevnar 13 were lower than in 2010 due to a successful vaccination programme that year. The patent expiries of Vfend and Xalatan in the US cost the unit $205m, 5% of fourth-quarter 2010 revenues.

The Emerging Markets unit saw volume growth more than offset by the negative impact of foreign exchange and increased price pressures, as well as the patent expiry of Lipitor in Brazil and Mexico in 2010. Patent expiries cost the unit $29m, 1% of the fourth-quarter 2010 figure.

The Established Products unit suffered from the patent expiries of Effexor XR, Protonix and Zosyn in the US, which cost the unit $208m (9% relative to fourth-quarter 2010). It also suffered from multi-source generic competition to Aricept in the US. These losses were partially offset by $150m from the addition of legacy King products, as well as by foreign exchange and by the licensing of Watson Pharmaceuticals to sell the authorised generic version of Lipitor in the US.

Pfizer reduced its total costs, excluding the impact of foreign exchange, by 5% relative to fourth-quarter 2010. This was achieved through cost-reduction and productivity initiatives, particularly in R&D, as well as reductions in the US field force and in marketing spend.

Ian Read, Pfizer’s Chairman and CEO, said: “Overall, 2011 was a year of setting new direction and focus for Pfizer. I am pleased with our 2011 financial performance, which was achieved in the face of a challenging global market and product losses of exclusivity of approximately $5 billion.

“In 2011, we advanced our pipeline and improved the rigour and productivity of our R&D efforts, while also changing the culture within the R&D organisation to be more accountable and results-driven. With the steady cadence of new product launches, marketing submissions and approvals, and positive late-stage clinical data presentations, we are clearly seeing the benefits of our investments and new approach.

“Prevnar/Prevenar 13 for adults, tofacitinib, Xalkori, Inlyta (axitinib) and Eliquis are well positioned to be important new product opportunities that may enhance the performance of our business. Additionally, we have a next wave of compounds that have shown promise in early and mid-stage studies, and we look forward to progressing them through the pipeline.”

Looking to 2012, he concluded: “We will continue to fix the innovative core in order to enhance our post-proof-of-concept portfolio of compounds in high-priority disease areas and successfully launch additional novel products. I look forward to continuing the significant progress we’ve made.”

Bristol-Myers Squibb saw net sales increase 7% to $5.5 billion in the final quarter of 2011, and record annual sales up 9% to $21.2bn.

Sales in the US increased 8% to $3.6bn with international sales also up by 4% after Onglyza, Sprycel, Orencia and Baraclude all saw revenue increase in the quarter.

Lamberto Andreotti, Chief Executive Officer, BMS, said the “solid financial results” conclude a “very good year” for the New York-based biopharmaceutical company.

But the company expects global sales in 2012 to fall to between $17.2bn and $18.2bn after the exclusivity of Avapro expires in March and Plavix expires in May.

In the final quarter of 2011, gross margin as a percentage of net sales improved by nearly three-quarters (74.9%). R&D costs remained flat at a $1bn with marketing, selling and administrative functions also slightly over a billion pound. Advertising and product promotion increased slightly in Q4 to $285m.

Global sales between October and December were led by Onglyza – which saw sales increase in the quarter by 110%. Sprycel saw sales rise by 34%, Orencia by 27% and Baraclude by a fifth. Skin cancer treatment Yervoy also generated sales of $144m.

The year concluded with BMS receiving approval for Yervoy and for kidney transplant drug Nulojix in the US and Europe, and for Eliquis in Europe for the prevention of venous thromboembolic events.

“Our delivery of several important new products to patients, the ability of our productive R&D organisation to build an innovative and diverse pipeline, and our continued commitment to business development gives us confidence in our future,” said Lamberto Andreotti.

Eliquis (apixaban) has been recommended in final NICE guidance as a treatment option for the prevention of venous thromboembolism (VTE) in adults who have undergone planned total hip replacement or total knee replacement surgery.

The treatment, which was launched in the UK in September 2011, was fast-tracked by NICE after the convenient drug was proven to help prevent blood clots.

Professor Carole Longson, NICE Health Technology Evaluation Centre Director, says that Eliquis “has been shown to be a clinically and cost effective option”.

Hip and knee replacement surgery has a high risk of VTE developing and patients require effective treatment to prevent potentially fatal clots forming. Without the use of suitable medication, the incidence of deep vein thrombosis ranges from 41% to 85% after elective knee surgery and to 42% to 57% after elective hip surgery.

“VTE is often difficult to spot because patients may not always have symptoms to give a warning,” said Professor Longson. “Even if a blood clot does not come loose, it can still cause long-term damage to the veins – for example, ‘post-thrombotic syndrome’ may develop up to two years following DVT, causing chronic swelling and ulceration of the legs. We are therefore pleased to be able to recommend its use (Eliquis) in the NHS in England and Wales alongside other effective treatments already approved by NICE.”

Eliquis was also approved for the same indication by The Scottish Medicines Consortium (SMC) in December 2011.