NICE has issued final guidance recommending Lucentis (ranibizumab) as a treatment for visual problems caused by macular oedema.

The injectable Novartis drug is recommended as a treatment for macular oedema caused by central retinal vein occlusion (RVO), or by branch RVO where laser treatment has failed or is not suitable.

NICE recommends the drug should only be prescribed under the terms of the patient access scheme agreed by Novartis with the Department of Health.

Macular oedema occurs when fluid collects in the central area of the retina, harming the ability to see detail and colour.

The condition is associated with increased production by damaged cells of vascular endothelial growth factor (VEGF), which worsens the leakage of fluid.

The underlying cause of macular oedema is often RVO, risk factors for which include advanced age, high blood pressure and diabetes.

Lucentis, the only anti-VEGF drug currently licensed in the UK for treatment of RVO, can reduce oedema and limit (or even reverse) visual loss.

Professor Carole Longson, Director of the Health Technology Evaluation Centre at NICE, said: “Macular oedema can cause blurred vision or a sensitivity to light, both of which can be very frightening and can significantly affect a person’s everyday life. These symptoms can come on suddenly, and if left untreated can cause blindness.

“NICE is, therefore, pleased to recommend ranibizumab in people with CRVO and some people with BRVO, following the submission of a patient access scheme, which makes the treatment more cost-effective.”

Novartis commented that the NICE announcement was “an important and long-awaited milestone in the management of this common eye disease.”

Jetrea (ocriplasmin), a drug used to help prevent sight loss through vitreomacular traction (VMT), has been launched in the UK.

The launch by Alcon, a division of Novartis, represents the drug’s first entry into the European market.

Developed by Belgian company ThromboGenics, Jetrea could help to save the sight of over 250,000 patients in Europe.

Alcon has entered into a partnership with ThromboGenics to sell Jetrea outside the US.

The manufacturer has now received two €45m milestone payments from Alcon: one for the drug’s EU approval and one for its first sale in the UK.

Jetrea is currently undergoing NICE appraisal, with guidance expected near the end of 2013.

VMT is a progressive age-related condition in which the vitreous humour becomes too strongly attached to the retina, eventually tearing it.

Administered by a single injection, Jetrea (an enzyme suspension) breaks down the protein fibres that cause traction on the retina. It can prevent damage to the retina or stop existing damage from becoming worse.

The only current treatment is late-stage surgery to repair a damaged retina, but this is often too late to save the patient’s sight.

“The launch of Jetrea in Europe by Alcon so shortly after gaining European approval is testimony of our joint commitment to ensuring patients in Europe have access to this innovative drug as soon as possible,” said Dr Patrik De Haes, CEO of ThromboGenics.

“We expect that Alcon will roll out Jetrea into other European markets in the coming months and are working with our partner to ensure that all the support for physicians, payers and patients is fully in place.”

NICE has recommended Lucentis (ranibizumab) for the treatment of visual impairment due to Retinal Vein Occlusion (RVO).

In a Final Appraisal Determination, the last stage before published guidance, NICE approved the Novartis drug for use in patients with either central or branch RVO where laser treatment is not suitable.

The recommendation means that Lucentis has NICE recommendation for the three leading causes of disease-related blindness: wet AMD, diabetic retinopathy and RVO.

Lucentis is the only anti-VEGF (vascular endothelial growth factor) drug licensed to treat RVO. VEGF is produced excessively by damaged retinal cells and triggers further cell damage.

About 17,000 people each year in the UK are diagnosed with RVO, and final NICE guidance recommending Lucentis would mean the drug became available to many of these patients.

Injected into the eye, Lucentis can be administered at a personalised dosage level. Clinical trials have shown that it can achieve significant and lasting improvements in vision-related functions.

Ian Pearce, Consultant Ophthalmologist and Vitreo-Retinal Surgeon at Royal Liverpool Hospital, described the NICE decision as “great news” for people with RVO, whose quality of life is often significantly affected by the disease.

“Ranibizumab is an established and well-tolerated treatment which when used to treat RVO can lead to rapid and significant gains in vision,” he said. “The impact of this cannot be underestimated as it can make the difference in a person’s ability to carry out everyday tasks such as reading and driving.”

Lucentis was developed by Genentech and Novartis in partnership. Genentech markets the drug in the US, while Novartis markets it in the rest of the world.

Pharmaceutical companies Otsuka and Lundbeck have expanded their collaboration to include the promotion of schizophrenia drug Abilify (aripiprazole) in 14 EU countries from 1 April.

The two companies will co-promote Abilify, which is currently marketed by Otsuka, in the UK and six other European countries.

Lundbeck will promote the antipsychotic drug in Ireland and six other EU countries.

The collaboration covers all forms of Abilify that are available: three oral formulations and the rapid intramuscular injectable version.

Abilify is now the biggest-selling drug in the US, despite the limited incidence of schizophrenia (an estimated 1% of the population).

Otsuka and Lundbeck will jointly promote Abilify in Denmark, Finland, Germany, Italy, Spain, Sweden and the UK, while Lundbeck will promote it in Austria, Belgium, Ireland, the Netherlands, Poland, Portugal and Romania.

Taro Iwamoto, President of Otsuka, said: “The agreement will further strengthen the Abilify brand in Europe and also position Otsuka and Lundbeck to successfully develop and launch up to five more new products there.”

The partners are about to launch a new monthly injectable version, Abilify Maintena, in the US, and submitted it to for EMA approval in December 2012.

Ulf Wiinberg, CEO of Lundbeck, commented: “Abilify Maintena represents a treatment option for patients and their physicians and caregivers seeking an alternative long-term maintenance treatment for schizophrenia, and we are pleased to join Otsuka in launching this first product as part of our extensive global alliance.”

Aripiprazole is a partial D2 dopamine receptor agonist that has been shown to reduce the risk of relapses in people suffering from schizophrenia.

Otsuka and Lundbeck signed an agreement to collaborate in the development and promotion of drugs to treat central nervous system disorders in November 2011.

A new injectable drug has been approved for use in the EU to help control type 2 diabetes, alongside basal insulin or oral medication.

Lyxumia (lixisenatide) from Sanofi is the first once-daily prandial GLP-1 receptor agonist, a drug that stimulates the pancreas to produce more insulin during meals.

Licensed by Sanofi from Danish biotechnology company Zealand Pharma, Lyxumia can improve blood glucose control by reducing the ‘peaks’ induced by meals.

It is indicated for adjunctive use together with basal insulin or an oral glucose-reducing drug when these alone do not deliver effective control.

The approval was based on the GetGoal clinical trial programme, which involved more than 5,000 patients with type 2 diabetes and showed that Lyxumia achieved a marked post-prandial reduction in blood glucose and a significant long-term HbA1c reduction.

It also helped to reduce body weight, and its side-effects (nausea and vomiting) were short-lived. Risk of hypoglycaemia was limited.

“Patients with Type 2 diabetes are not all alike,” said Dr Filip K. Knop of Gentofte Hospital, University of Copenhagen. “One issue is that patients treated with basal insulin often move away from their target HbA1c despite well-controlled fasting plasma glucose.

“Adding a short-acting GLP-1 receptor agonist with a pronounced effect on post-prandial glucose, like once-daily Lyxumia, may be a good way of getting these patients back at target without increasing the risk of hypoglycaemia.”

Lyxumia is a glucagon-like peptide-1 receptor agonist (GLP-1 RA): it enhances the action of GLP-1, a naturally occurring peptide hormone that is released while eating a meal and stimulates insulin secretion by pancreatic cells.

Sanofi has in-licensed the drug from Zealand Pharma, who will receive low double-digit percentage royalties on global sales.

An established blood cancer drug is now available in a subcutaneous form, cutting the administration time from two hours to five minutes.

The subcutaneous (SC) form of Roche’s MabThera (rituximab), used to treat non-Hodgkin lymphoma (NHL), could improve patient experience while freeing up time in chemotherapy suites.

MabThera SC uses a new biological technology from Halozyme that locally and reversibly breaks down sub-skin tissues.

The SABRINA phase III trial compared the effects of MabThera SC and MabThera IV in patients with previously untreated follicular lymphoma.

It proved the non-inferiority of MabThera SC, with an objective response rate (proportion of patients whose cancer shrinks by over 50%) of 90.5% for SC and 84.4% for IV.

Roche has applied to the European Medicines Authority (EMA) for an updated licence to allow NHL patients in the UK to receive MabThera SC.

MabThera IV is the standard treatment for NHL. In MabThera SC the drug is combined with the human enzyme hyaluronidase, which temporarily increases the penetrability of the tissue layer under the skin, allowing rapid absorption.

Dr Andrew Davies, Consultant in Medical Oncology at the University of Southampton, said: “This is a new formulation of a drug we are very familiar with and have been using for many years. In Southampton, we have observed a high degree of patient preference and satisfaction with this new formulation of rituximab.”

NHL is one of the most common cancers in elderly people; over 12,200 people are diagnosed with it each year in the UK.

Halozyme has four technology partnerships involving the use of hyaluronidase to facilitate SC injections. Its partnership with Roche has also produced an SC version of Herceptin.

The company’s other partnerships to exploit this technology are with Baxter Healthcare, ViroPharma and Intrexon.

The controversy over whether Avastin can replace Lucentis as a treatment for wet AMD has intensified following the publication of a major clinical study.

The CATT study, a head-to-head comparison of the two injectable drugs, suggests that Avastin is comparable to the more expensive Lucentis in terms of clinical efficacy.

However, the study also highlights that Avastin may increase the risk of major adverse events such as blood clots and congestive heart failure.

Roche’s Avastin (bevacizumab) is not licensed for treatment of the eye disorder wet AMD, which affects many elderly people, in Europe or the USA.

However, its off-label use has become widespread because it is much cheaper than the standard treatment, Roche’s Lucentis (ranibizumab) – which is marketed outside the US by Novartis.

In the UK, Lucentis (which costs £890 per dose) is the only NICE-approved treatment for wet AMD, but some PCTs recommend the use of Avastin (at £50–100 per dose) to save money.

Novartis is currently seeking a judicial review of the recommendation of Avastin for wet AMD by one PCT cluster.

The two-year Comparison of Age-related macular degeneration Treatment Trials (CATT), carried out by the National Eye Institute in the US, has concluded that both drugs offer “robust and lasting” improvements in vision.

However, those patients taking Avastin show a higher incidence of serious adverse events (40%) than those taking Lucentis (32%). The high figures reflect the median age (over 80) of the study participants.

The adverse events recorded include arterial and venous blood clots, haemorrhagic stroke, congestive heart failure and vascular death

The study authors concluded: “The choice of drug and dosing regimen for patients must balance the comparable effects on vision, the possibility of true differences in adverse events, and the fortyfold difference in cost per dose.”

However, Novartis has drawn attention to the adverse event data, arguing that “it would be inappropriate to advocate use of unlicensed bevacizumab for wet AMD, on the basis of these trials,” and further noting that of the two drugs, only Lucentis was specifically designed for use in the eye.

A US consumer group has called on the FDA to withdraw its approval of Novo Nordisk’s injectable diabetes drug Victoza on safety grounds.

Public Citizen cited evidence that Victoza is associated with increased rates of pancreatitis and kidney failure, as well as causing thyroid cancers in rodents.

Novo Nordisk commented that the evidence cited in the petition is adequately covered by Victoza’s label.

The FDA approved Victoza in 2010 against the recommendation of three staff scientists, the consumer group claimed.

One of them, Dr Karen Mahoney, wrote in an FDA memo: “The need for new therapies for Type 2 diabetes is not so urgent that one must tolerate a significant degree of uncertainty regarding serious risk concerns.”

The FDA had noted that Victoza caused thyroid tumours in rats and mice. The product label states that it is “unknown” whether the drug could have a similar effect in humans, and recommends that patients with a family history of thyroid cancer should avoid the drug.

Similarly, Victoza’s label refers to the increased risk of pancreatitis and to certain incidents of kidney failure.

Public Citizen noted that in the first 17 months of Victoza’s use, the FDA received 200 reports of patients diagnosed with pancreatitis. The group estimated that only 10% of actual cases were reported.

Novo Nordisk said the FDA’s approval was based on extensive studies involving more than 4,000 patients, and that since then the company “has continued to work closely with the FDA and the medical community to monitor the benefits and appropriate use” of the drug.

Novo Nordisk’s Chief Science Officer, Mads Krogsgaard Thomsen, commented that the rodent studies were of no relevance to human patients. “We do not expect any consequences for Victoza from Public Citizen’s petition,” he said.

GlaxoSmithKline (GSK) has reported successful phase III trials of its new diabetes drug albiglutide, which it intends to file for regulatory approval.

The injectable drug, taken weekly, outperformed a rapid-acting insulin when used in combination with a daily insulin to manage type 2 diabetes.

Analysts predict the drug will earn GSK $250m per year by 2016 – not a potential ‘blockbuster’, but a robust product in the diabetes market.

Albiglutide – awaiting a new brand name after GSK dropped the name Syncria – is the latest product in the class of glucagon-like peptide-1 (GLP-1) diabetes drugs that includes Victoza from Novo Nordisk and Byetta from Amylin and Lilly.

GLP-1 drugs stimulate insulin release when glucose levels are high, a flexible property that makes them a potential alternative to insulin in patients with severe type 2 diabetes.

They have the further advantage of stimulating weight loss, which is of clinical value to most people with type 2 diabetes.

The first phase III trial of albiglutide, reported in November 2011, found it to be less effective than daily Victoza in reducing blood glucose levels – a disappointing result for GSK.

However, armed with top-line results from seven of eight phase III studies, GSK said that the cumulative data support an application for the drug’s approval as a treatment for type 2 diabetes.

One trial tested albiglutide against Lilly’s rapid-acting insulin Humalog when used in combination with Sanofi’s daily insulin Lantus.

The patients taking albiglutide experienced a 0.82 reduction in HbA1c, compared to 0.66 in the Humalog group. In addition, The albiglutide patients also lost an average of 0.73 kg in weight, whereas the Humalog patients gained 0.81 kg.

GSK expects to have all the data it needs to apply for regulatory approval by the end of 2012.

The European Medicines Agency (EMA) has recommended lifting the suspension of blood loss restricting medicine Trasylol (injectable aprotinin), denied EU marketing authorisation since 2008.

The review stated that the results of the BART study, on which the suspension was based, were unreliable and not supported by later studies.

The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that Trasylol’s benefits outweigh its risks in a more narrowly defined group of patients than before.

The review examined the benefits and risks of all antifibrinolytic drugs, which prevent excessive blood loss by helping to preserve blood clots.

Before its suspension in 2008, Bayer’s Trasylol was authorised in the EU for patients undergoing heart bypass surgery, reducing the risk of major bleeds.

The CHMP concluded that the drug has a positive benefit-risk balance in patients undergoing isolated heart bypass surgery who are at high risk of major blood loss.

Trasylol sales were suspended in May 2008 on the recommendation of the CHMP, following the preliminary results of the BART study with high-risk heart surgery patients, which appeared to show an increased death rate with Trasylol after 30 days relative to other medicines.

The current review compared the final results of the BART study with those of other clinical studies and wider research and clinical data. It concluded that the BART study did not take account of imbalances in the use of blood-thinning medicines such as heparin, and that its findings were not replicated in other studies.

The CHMP further recommended that doctors be warned of the importance of heparin, and that the use of Trasylol in the EU be monitored through a registry.