The Scottish Medicines Consortium (SMC) has approved the use of RoActemra (tocilizumab) as a single therapy for rheumatoid arthritis (RA).

The Roche drug is an alternative to the standard therapy, methotrexate (MTX), which one-third of RA patients cannot tolerate.

The approval reflects the priority of helping patients to achieve remission from a chronic disease that damages the joints, leading to progressive disability.

Tocilizumab is a biological therapy: it targets specific chemical signals or receptor cells.

It has been found to offer remission rates four times better than the most prescribed alternative, adalimumab (Humira), and to offer a reduction in joint swelling and disability.

The drug is available in combination with MTX in England, but the Scottish decision represents its first approval as a monotherapy for RA.

An auto-immune disease, RA affects 646,000 people in the UK, causing disabling joint damage within a decade in 50% of cases.

Dr David Marshall, Consultant Rheumatologist at NHS Greater Glasgow & Clyde, said: “RA is a progressive disease which can lead to irreversible joint damage and disability. We need to treat patients as quickly and aggressively as possible, using the most efficacious treatments available.

“Remission in RA is achievable for many patients and this is what we should be aiming for. This news will make a real difference to the treatment of RA and to patients’ lives, who until now have had limited treatment options.”

Eisai has received recommendations from the European Medicines Agency (EMA) for two of its portfolio of anti-epilepsy drugs (AEDs).

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended extending the use of Zonegran (zonisamide) to a monotherapy for partial seizures in adults with newly diagnosed epilepsy.

It has also recommended the use of Fycompa (perampanel) as an adjunctive treatment of partial-onset seizures in patients with epilepsy aged 12 or older.

Epilepsy is a chronic brain disorder that affects an estimated six million people in Europe, and AEDs are a major strategic focus for Eisai in this market.

The recommendation of Zonegran as a monotherapy is important because patients with newly diagnosed epilepsy find combination therapies particularly difficult to tolerate.

Michel Baulac, Head of the Clinical Department at the Hospital de la Pitie-Salpetriere, Paris, France, said: “Monotherapy remains the optimal approach for managing patients with epilepsy. In addition to a good tolerability profile and to the absence of interaction with other drugs, in particular with oral contraceptives, zonisamide offers the added value of a once-daily dosing.”

Fycompa is a new option for the management of partial-onset epilepsy, as it selectively blocks a particular type of seizure-inducing neurotransmission.

“Improving seizure control is one of the most pressing unmet needs in epilepsy patients,” commented Professor Bernhard Steinhoff, Medical Director of the Epilepsy Center at Kehl-Kork, Germany. “Perampanel will be a completely new option for the adjunctive treatment of patients with uncontrolled seizures.”

Roche’s Zelboraf (vemurafenib) has been approved by the European Commission as a monotherapy for the treatment of adults with BRAF V600 mutation positive unresectable or metastatic melanoma.

The skin cancer treatment is the first and only personalised medicine that allows patients with BRAF V600 mutation-positive metastatic melanoma to live significantly longer.

Hal Barron, Chief Medical Officer and Head, Global Product Development, said the approval is “important news” as Zelboraf “significantly improves patient survival”.

Zelboraf is designed to target and inhibit mutated forms of BRAF found in approximately half of all cases of skin cancer.

In pivotal clinical trials, it demonstrated patient survival in previously untreated and treated those with advanced melanoma who tested positive for BRAF V600 mutations in Roche’s cobas 4800 BRAF V600 Mutation Test.

Data from the Phase III BRIM3 trial showed that the risk of death fell by 63% in people receiving Zelboraf compared to those receiving standard first-line treatment.

Post-hoc analysis of BRIM3 data with a follow-up compared to previous analyses also showed Zelboraf significantly improved survival by a median overall survival (OS) of 13.2 months compared to 9.6 months for chemotherapy.

Last year, the medication became the first and only personalised medicine approved by the FDA for the same indication. It has also recently been approved for use in Switzerland, Brazil, Israel, Canada and New Zealand.

Novartis’ Galvus (vildagliptin) has been approved for use by the European Commission for patients with type 2 diabetes who cannot take metformin, the current standard treatment.

The approval is based on data from clinical trials which assessed the drug as a monotherapy and found the treatment delivered improvements in glycaemic control, was generally well-tolerated and associated with a low risk of hypoglycaemia.

David Epstein, Head of Novartis, expects the brand to develop into a “blockbuster, we believe, quite soon”.

Galvus is already approved in the EU as an add-on treatment to metformin, sulphonylureas and thiazolidinediones. Towards the end of 2011, it received approval for patients with type 2 diabetes and moderate or severe renal impairment.

Last year it recorded sales of $677 million, an impressive increase of 66%, despite not being available in the USA. But it is the latest approval which has caused excitement at Novartis. The company estimates that more than 47 million Europeans have type 2 diabetes. It estimates this total will rise to 57 million people by 2030, with a quarter of these people unable to take metformin due to intolerance or contraindications.

Counterfeit and substandard antimalarial drugs are undermining the war against malaria in Africa, a new report has claimed.

Researchers from the Wellcome Trust-Mahosot Hospital-Oxford University Tropical Medicine Research Collaboration warned that drugs with incorrect doses, or with erroneous active ingredients, could increase drug resistance in malaria patients.

The report, which called for urgent action to save millions of lives worldwide, identified two problems: fake drugs being sold fraudulently, and substandard drugs arising from poor manufacturing.

The recommended antimalarial drugs are artemisinin derivatives, used as monotherapy or in combination with other drugs.

The researchers gathered medication data from 11 nations in Africa between 2002 and 2010.

They identified many drugs used to treat malaria that contained erroneous active ingredients, treating the symptoms but not the disease itself.

In addition, they identified drugs with small quantities of the correct active ingredient – sufficient to pass chemical tests, but more likely to cause resistance to artemisinin without benefiting the patient.

Some of the fake antimalarials were traced to China.

Study leader Dr Paul Newton said: “Malaria can be readily treated with the right drugs of good quality, but poor-quality medicines – as well as increasing mortality and morbidity – risk exacerbating the economic and social impact of malaria. Worse still, they encourage drug resistance, potentially resulting in the failure of artemisinin treatments. Failure to take action will put at risk the lives of millions of people, particularly children and pregnant women.”

He also recommended that clinicians fighting malaria rely exclusively on combination therapies, which are harder to counterfeit.

“This research is very worrying and should act as an early warning,” said Dr Jimmy Whitworth, Head of International Activities at the Wellcome Trust. “We have already begun to see the emergence of drug-resistant malaria parasites in South-East Asia; substandard and counterfeit antimalarials and the availability of artemisinin monotherapies threaten to lead to the spread of drug resistance in Africa. If this happens, the effect could be devastating on efforts to control malaria in Africa."

Malaria caused approximately 781,000 deaths worldwide in 2009, according to the World Malaria Report 2010.

A combination of a branded drug from Boehringer Ingelheim and Eli Lilly and a drug widely available in generic form has been shown in a phase III trial to be effective in treating type 2 diabetes.

Boehringer and Lilly’s Trajenta (linagliptin) in combination with metformin was shown to be more effective in controlling blood glucose levels than metformin alone.

Metformin, a successful glucophage drug for control of type 2 diabetes, was developed by Bristol-Myers Squibb and is now available in multiple branded and generic formulations.

Both drugs are used as monotherapies for type 2 diabetes in the UK, and some doctors already prescribe them together; but the new findings are likely to make the combination a standard treatment option.

The 24-week trial, part of a wider phase III study of the combination, showed that poorly controlled patients who received both drugs achieved an average reduction of 3.7% in HbA1c.

The drug combination was well tolerated, with only 9% of patients suffering side-effects and only 1.5% suffering hypoglycaemic events.

A previous one-year monotherapy trial had shown Trajenta to be of similar efficacy to glimepiride but with a significantly lower risk of side-effects, hypoglycaemic events and weight gain.

Trajenta is also the only approved diabetes medication with no need for dose adjustment in adult patients.

Professor Klaus Dugi, Corporate Senior VP of Medicine at Boehringer Ingelheim, said: “Many patients with high HbA1c levels require more than metformin alone to reach their blood glucose targets. Linagliptin can support patients with type 2 diabetes to effectively manage their condition.”

GlaxoSmithKline’s breast cancer drug Tyverb (lapatinib) has failed to show a significant increase in disease-free survival (DFS) when used alone in patients with early-stage HER2-positive breast cancer.

The results of the TEACH phase III clinical trial mean that Tyverb (known as Tykerb in the US) is unlikely to succeed as a monotherapy in this indication, though it will continue to be used in combination therapy.

The TEACH trial established that 13% of patients treated with Tyverb following initial surgery or chemotherapy for breast cancer achieved DFS after four years, compared to 17% on placebo.

The trial did not compare Tyverb with Roche’s breast cancer drug Herceptin (trastuzumab). The two drugs were approved by the FDA for use in combination in 2007, and in that indication earned GSK $360 million in 2010.

However, whereas Herceptin has proved successful as a monotherapy, Tyverb has not. In September, GSK abandoned the monotherapy arm of another trial (ALTTO) after concluding that Tyverb was less effective in treating early-stage breast cancer than Herceptin alone.

The TEACH trial is still expected to support the use of Tyverb in combination with Herceptin.

“We are disappointed that the improvement in disease-free survival with lapatinib monotherapy in TEACH did not reach statistical significance,” said Rafael Amado, Senior VP of Oncology Development at GSK.

“Lapatinib combination therapy remains an important treatment option for patients with metastatic HER2-positive breast cancer whose disease has progressed on treatment with trastuzumab-based regimens.”

Halaven (eribulin) has not been recommended by the SMC as a treatment option for locally advanced or metastatic breast cancer on the NHS in Scotland.

The Consortium analysed data from Phase III trials which showed patients had 2.5 months additional survival compared to existing treatments, but considered Halaven too expensive.

Nick Burgin, European Director of Market Access, Eisai, says the company is “hugely disappointed” and plans a resubmission later in the year to “reverse this unfair decision”.

Eisai launched Halaven in the UK in April and claims the price of the drug in Scotland is at “the lowest anywhere in the world”.

The medication is a novel monotherapy treatment indicated for patients with locally advanced or metastatic breast cancer who have progressed after at least two chemotherapeutic regimens for advanced disease.

Eisai says it is the first single agent chemotherapy to demonstrate prolonged overall survival who have had prior anthracycline and taxane treatment.

During the appraisal, the Consortium analysed data from the EMBRACE trials which showed a median overall survival benefit of 13.2 months for patients receiving Halaven compared to 10.5 months for patients receiving a ‘treatment of physician’s choice’.

Andrew Wilson, Chief Executive of the UK Rarer Cancers Foundation, says the decision highlights the discrimination women north of the border currently face. “Scottish women with advanced breast cancer are currently prejudiced in Scotland as their chances of accessing a life extending cancer drug are now much lower than their neighbours in England”, he said.

“Our recent report ‘Nations Divided’ uncovered a profound difference in the availability of new cancer medicines between Scotland and England. Following the implementation of the Cancer Drug Fund (CDF) in England, patients in Scotland are now three times less likely than patients in England to receive the drugs that their clinician wishes to prescribe.”

Halaven is currently approved in the European Union, USA, Switzerland, Japan, and Singapore but recently failed a similar appraisal by NICE in draft guidance who raised concerns about the medication’s side effects.

Boehringer Ingelheim and Eli Lilly have launched Trajenta (linagliptin), a single dose, once-daily tablet for adults with type II diabetes mellitus (T2DM) in the UK.

Trajenta has been shown to deliver significant HbA1c reductions compared to placebo and was generally well tolerated in clinical trials involving more than 4,000 patients.

Professor Anthony Barnett, Consultant Physician and Emeritus Professor of Medicine, Heart of England NHS Foundation Trust and University of Birmingham, says its release is “an important advance in the management” of diabetes.

The drug is licensed for adults with T2MD as a monotherapy in patients inadequately controlled by diet and exercise alone, and for whom metformin is inappropriate due to intolerance, or contraindicated due to renal impairment.

It is also licensed in combination with metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control; and in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.

In clinical trials, a mean HbA1c reduction from baseline of 0.7% was sustained over 102 weeks as add on to metformin and a sulphonylurea in patients using Trajenta.

Around a third of people with diabetes are affected by chronic kidney disease. The convenient tablet is the only dipeptidyl peptidase-4 (DDP-4) inhibitor which is primarily excreted via the bile, and the first in this class licensed for use in T2DM, irrespective of degree of renal impairment.

“Linagliptin offers the benefits of the DPP-4 inhibitor class with good tolerability, weight neutrality and low risk of hypoglycaemia and the additional advantage of health professionals being able to prescribe without dose adjustment irrespective of the patient's renal function,” added Professor Anthony Barnett. “Renal impairment is common in people with type 2 diabetes so this latter point is extremely important.”

Roche’s Tarceva (erlotinib) has been granted a European licence as a first-line monotherapy for patients with an advanced form of non-small cell lung cancer (NSCLC) with a certain mutation.

The licence is based on Phase III trials which showed Tarceva nearly doubled the time patients lived without their disease progressing compared with chemotherapy.

Dr Liz Toy, Royal Devon and Exeter Foundation NHS Trust, says the new indication is “exciting news” for patients who may have an “enhanced response” using the treatment.

Tarceva is already approved for use in the UK for patients with advanced or metastatic NSCLC, irrespective of a patient’s epidermal growth factor receptor (EGFR) status.

Data from the two Phase III studies, EURTAC and OPTIMAL, investigated patients with an EGFR mutation and demonstrated that Tarceva significantly increased the time patients live without the cancer progressing.

“The European approval for Tarceva is good news for patients with a genetically distinct form of lung cancer because these patients may derive greater benefit when the medicine is used as an initial treatment,” said Hal Barron, Chief Medical Officer and Head, Global Product Development at Roche.

More than 39,000 new cases of lung cancer are diagnosed in Britain each year.