Gilenya (fingolimod) has become the first pill-based treatment for highly active relapsing-remitting multiple sclerosis (RRMS) recommended on the NHS after being backed in final guidance by NICE.

NICE had originally failed to recommend the pill in draft guidance but reconsidered its decision after Novartis and clinicians provided additional information and analysis on the effectiveness of the medication.

Professor Carole Longson, Director of the Health Technology Evaluation Centre at NICE, says the convenient treatment “is a valuable new therapy” for patients with RRMS.

RRMS is estimated to affect around 27,500 people in England and Wales and is the most common type of multiple sclerosis. Treatments to manage relapses are usually administered by injection.

NICE now specifically recommends the “innovative” treatment for adults who have an unchanged or increased relapse rate or ongoing severe relapses compared to the previous year, despite treatment.

But NICE states the recommendation only applies if Novartis provides Gilenya under the proposed terms in its confidential Patient Access Scheme it agreed with the DH.

“We are pleased to recommend fingolimod as a treatment option for the specific patient population for whom it has been demonstrated to be cost effective, providing Novartis applies its proposed discount,” said Professor Longson. “Multiple sclerosis can be a disabling condition and so we hope that this novel treatment will help to reduce relapses for these people.”

The treatment recently had its label updated to include new prescribing guidelines after the EMA and FDA raised concerns over cardiovascular events in certain patients.

Multiple sclerosis (MS) treatment Gilenya (fingolimod) has had its prescribing information updated after discussions with the EMA and the FDA.

Novartis has agreed to the updates to provide healthcare professionals with further guidance on initiating its use in patients with MS after reviews by both health regulators following cardiovascular concerns in certain patients.

Patients starting the use of Gilenya should have an electrocardiogram (ECG) and blood pressure measurement prior to the first dose with regular updates and continuous ECG monitoring for a minimum of six hours afterwards.

The CHMP has now confirmed a positive benefit-risk profile for the once-daily oral medication following the label change.

“We believe that Gilenya is a valuable treatment option for many patients with relapsing-remitting MS, and we welcome the confirmation of the positive benefit-risk profile of the drug which also supports our continued belief of the blockbuster potential of Gilenya,” said David Epstein, Division Head of Novartis Pharmaceuticals.

In additional, the label update in the EU also cautions against Gilenya’s use in patients who may be less tolerant of it or are more likely to develop a significantly slowed or abnormal heart rate because of certain underlying conditions or concomitant medications.

In the EU, Gileyna is approved for people with highly active relapsing-remitting MS despite treatment with beta interferon, or in patients with rapidly evolving severe relapsing-remitting MS.

The CHMP’s labelling recommendations will be reviewed by the European Commission with a final decision expected in June 2012.

The EMA has started a review into the benefits and risks of Novartis’ Gilenya (fingolimod) following concerns into cardiovascular effects in patients after the first dose.

The review begun after reports of heart problems in patients taking the multiple-sclerosis medication, as well as the unexpected death of one individual in the US less than 24 hours after taking the medication.

A further six unexplained deaths after treatment with Gilenya began have also been reported. Three of these were due to heart attack and one after the disruption of the heart rhythm. The EMA says it is not yet clear if these were caused by the medication or not.

The CHMP expects to complete the review by March 2012.

Gilenya has been authorised for use in the European Union since March 2011 for the treatment of patients with relapsing-remitting multiple sclerosis whose disease has failed to respond to a beta-interferon or is severe and getting worse rapidly. It has been used worldwide by more than 30,000 patients.

Doctors have now been advised to closely monitor patients after the first dose of the treatment has been administered. The medication’s product information does include recommendations for healthcare professionals to observe for signs and symptoms related to its side-effects for at least six hours after the first dose has been taken. The EMA says it was also aware of the risk of patients developing a slow heart rate after the first dose had been taken when it was authorised.

Novartis is cooperating with the review and has committed to supplying the CHMP with the results of its own investigations into the cardiovascular effects of Gilenya.

Novartis has received the thumbs up for Gilenya (fingolimod) and Lucentis (ranibizumab) in Europe.

The European Commission has granted approval for Gilenya as a disease modifying therapy for relapsing-remitting multiple sclerosis (RRMS).

The CHMP has also given a positive opinion on Lucentis to treat visually impaired patients due to macular oedema secondary to retinal vein occlusion (RVO).

David Epstein, Head of Novartis Pharmaceuticals (pictured), said the company was “dedicated to bringing innovative new treatments to patients where there is significant unmet need” and was pleased with both decisions.

The convenient Gilenya capsule 0.5 mg daily has been granted approval for patients with RRMS patients despite treatment with beta interferon, or in patients with rapidly evolving severe RRMS.

Its approval was based on the largest clinical trial program submitted to date for a new MS drug. Data from the studies showed significant efficacy in reducing relapse, the risk of disability progression, and the number of brain lesions detected by magnetic resonance imaging (MRI).

Professor Hans-Peter Hartung, Professor and Chairman, Dept. of Neurology, Heinrich-Heine University, Germany, says Gilenya’s approval is “an important step forward” for patients.

Lucentis’ positive opinion was also based on data from two Phase III studies in patients with Branch RVO (BRAVO) and Central RVO (CRUISE). Studies showed that nearly 60% of BRVO and almost half (48%) of CRVO patients treated with monthly Lucentis gained at least 15 letters of visual acuity at six months, compared with 29% and 17% of those treated according to current standard practice, respectively.

“If approved, Lucentis would be the first anti-VEGF therapy licensed for the treatment of RVO in Europe,” said David Epstein.

“This would be in addition to the Lucentis approvals for patients with wet age related macular degeneration and patients with vision loss due to diabetic macular edema.”

Lucentis is currently licensed in more than 85 countries for the treatment of wet age-related macular degeneration (AMD) and in the European Union for visual impairment due to diabetic macular edema.