The European Commission has approved the use of Abbott’s Humira (adalimumab) for the treatment of moderately to severely active ulcerative colitis (UC) in adults.

The approval sees Humira become the first and only self-injectable biologic therapy for UC in adults who have failed to respond to conventional therapy.

Marco Greco, Chairman of the European Federation of Crohn’s & Ulcerative Colitis Associations, said the approval “represents an important new therapeutic option”.

Humira is already indicated for the treatment of several other inflammatory diseases. Dr John Leonard, Senior Vice President, Pharmaceuticals R&D, Abbott, says the latest indication highlights the treatment’s usefulness.

He commented: “The approval of Humira for the treatment of moderately to severely active ulcerative colitis further demonstrates Humira’s versatility in treating a wide range of immune-mediated inflammatory diseases”.

UC is a chronic inflammatory bowel disease that causes ulcers in the colon and may eventually lead to life-threatening complications. Around 1.2 million Europeans suffer with UC.

“Having one more option to treat this disease provides new hope that some patients will be able to achieve remission of their disease,” said Marco Greco.

The approval of Humira – which was first approved in the EU in 2003 for the treatment of rheumatoid arthritis – was based on two Phase III global trials including more than 800 patients.

The European Commission has granted marketing authorisation to Byetta (exenatide twice-daily) as an adjunctive therapy to basal insulin in adults with type 2 diabetes who have not achieved adequate glycaemic control.

The authorisation for adults who have not responded to metformin and/or Actos follows clinical trial data which showed Byetta helped reduced glucose levels and reduce patients’ weight.

Dr Christian Weyer, Senior Vice President, R&D, Amylin Pharmaceuticals, said the decision “provides a new option” for patients who are not “achieving treatment goals”.

Byetta, the first glucagon-like peptide-1 (GLP-1) receptor agonist to be approved by the FDA for the treatment of type 2 diabetes, has been used by more than 1.8 million patients globally since its introduction.

In the main, double-blind, 30-week clinical trials, submitted to the EC, Byetta demonstrated a statistically significant reduction of hypoglycaemia compared to placebo. Participants who added Byetta to their insulin glargine regimen also saw their weight decrease by an average of four pounds.

“In a clinical trial, patients using fixed-dose Byetta with titrated basal insulin achieved better postprandial and overall glycaemic control, without weight gain or an increased risk of hypoglycaemia, compared to patients using titrated basal insulin without Byetta,” said Dr Weyer.

Roche has launched its skin cancer drug Zelboraf (vemurafenib) in the UK for adults with unresectable or metastatic melanoma who test positive for the BRAF V600 genetic mutation.

The treatment was licensed by the European Commission last month for use as a single-agent therapy after it demonstrated in clinical trials that patients lived an average of 13.2 months longer than with standard chemotherapy.

Professor Alan Ashworth, CEO, Institute of Cancer Research, said it was pleasing that patients would be able to benefit from the personalised medicine.

Alongside Zelboraf, Roche has also launched a companion biomarker test to identify patients who could benefit from the advanced melanoma treatment.

In clinical trials conducted in the UK, patients with BRAF-mutant advanced cancers were shown to be almost nine times more likely to respond to Zelboraf than to standard chemotherapy.

The FDA approved the use of the cancer drug for a similar indication in August 2011. NICE is currently appraising the treatment with guidance expected to be issued in October.

Analysts have already predicted that annual sales of the drug may reach up to $1.5bn.

Janssen has launched a new partnership with Bupa Home Healthcare to support patients with chronic genotype-1 hepatitis C using Incivo (telaprevir).

The MYINCIVO Support Programme aims to increase adherence awareness through SMS text reminders, health coaching and advice from healthcare professionals.

Dr Peter Barnes, Medical Director at Janssen, says the programme has been created to help with the “challenging” and “significant commitment” needed by patients using hep C treatments.

During the development of the support programme, Janssen worked closely with Bupa Home Healthcare, healthcare professionals and patient support groups.

The confidential personalised programmes have been established to complement existing care provided by a patient’s specialist nurse or doctor and helps maintain continuity of care and support.

Patients have access to confidential advice and support to help them adhere to prescription guidelines and help maintain their health, stay motivated and be in control whilst undertaking treatment. Patients’ partners, carers and family members can also access the tailor-made programmes.

Confidential advice and support is available 24 hours a day, seven days a week, to support patients, carers or family members when they require assistance.

Dr Mehmood Syed, Medical Director at Bupa Home Healthcare, said that increasing “better health outcomes” for patients “is at the heart of this programme”.

“We want to empower patients so that they have more control over their health as well as provide them with dedicated medical expertise and support when they need it,” he said.

It’s estimated there are between 216,000 and 466,000 individuals who are chronically infected with hepatitis C in the UK.

Janssen’s Incivo received approval for use in combination with peginterferon alfa and ribavirin from the European Commission in September 2011.

Before the introduction of protease inhibitors, of which Incivo is the latest, treatment for genotype-1 chronic hep C cleared the virus in only around half of patients, leaving the other half without a successful outcome after 12 months of treatment.

Incivo has been shown in clinical trials to be more effective than standard treatment options in all genotype-1 patient types. In fact, the addition of Incivo to existing current standard treatment cleared the virus in a significantly greater number of patients who were previously untreated.

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.

The CHMP has adopted a positive opinion on MSD’s Remicade (infliximab) for the treatment of severely active ulcerative colitis (UC) in youngsters aged between 6 to 17 years old.

The Committee recommends the monoclonal antibody for those who have had an inadequate response to conventional therapy, or who are intolerant to medical contraindications for such therapies after a Phase III study demonstrated its efficacy.

Rupert Vessey, Senior Vice President, Research Laboratories, Merck, says the positive opinion is “encouraging news and a significant step” for younger patients in Europe.

If the medication if subsequently approved by the European Commission, it will be the first and only biologic therapy approved in the EU for the treatment of paediatric UC.

Paediatric UC is a debilitating condition that causes inflammation and painful swelling of the inner lining of the large intestine.

In clinical trials, Remicade demonstrated its efficacy in a Phase III, 54 week study in 60 youngsters diagnosed with moderately to severe active UC who had experienced an inadequate response to conventional therapies. In March 2006, it was approved in the EU for the treatment of moderately to severely active UC in adults.

Remicade also approved for use in Europe for:

• Severe, active Crohn’s disease in adult patients
• Fistulising, active Crohn’s disease in adult patients
• Rheumatoid Arthritis (in combination with methotrexate)
• in adult patients with active Rheumatoid Arthritis
• Severe, active ankylosing spondylitis in adult patients
• Active and progressive psoriatic arthritis in adults
• Moderate-to-severe plaque PsO in adults
• Moderately-to-severely active UC in adults
• Severe, active Crohn’s disease in paediatric patients aged 6 to 17 years old.

A decision from the European Commission on the CHMP’s recommendation is expected during the first quarter of 2012.