Novartis Pharmaceuticals UK Ltd.
Novartis Communications UK
Frimley
United Kingdom
http://www.novartis.co.uk
MEDIA RELEASE • MEDIA RELEASE • MEDIA RELEASE
For medical, consumer and industry health media only
Embargoed until 06:15 GMT, Tuesday 21 April 2015
New data analysis confirms patients treated with once daily pill Gilenya
(fingolimod) are nearly six times more likely to achieve no evidence of
disease activity (NEDA) across four key measures versus placebo

A new subgroup analysis from the pivotal FREEDOMS/FREEDOMS II studies has
confirmed that fingolimod-treated patients were nearly six-times more likely to
achieve no evidence of disease activity (NEDA4) than placebo1

Analysis confirms the efficacy of fingolimod across four key measures of disease
activity in MS - relapse, disability progression, MRI lesions and brain volume loss1

NEDA4 is a new treatment goal achieved when a patient has no relapses, no new
MRI lesions, no MS-related brain volume loss and no disability progression1
Frimley, 21 April 2015 – A new analysis from pivotal phase III studies for once daily pill
Gilenya (fingolimod) has confirmed that people with highly active relapsing multiple
sclerosis (RRMS) treated with fingolimod were nearly six times more likely to achieve no
evidence of disease activity across four key measures compared to placebo over two
years.1 The analysis was presented today at the 67th American Academy of Neurology
(AAN) Annual Meeting in Washington, DC, USA.
No evidence of disease activity (NEDA) is a new treatment goal that reflects a shift in
expectations to a more complete response to disease modifying therapies (DMTs), such
as fingolimod.1,2 NEDA4 incorporates normalised brain volume loss as its fourth
component, in addition to relapse reduction, MRI and disability progression.1 NEDA4 is
achieved when a patient has no relapses, no new MRI lesions, no MS-related brain
volume loss and no disability progression.1
The analysis from the pivotal phase III FREEDOMS and FREEDOMS II studies set out to
examine the impact of fingolimod treatment on NEDA4 outcomes in patients with high
disease activity, despite prior use of a DMT.1 The results showed that fingolimod-treated
patients were almost six times more likely to achieve NEDA4 status (no relapses, no new
MRI lesions, no MS-related brain volume loss and no disability progression) compared to
patients treated with placebo.1
According to Professor Gavin Giovannoni, Chair of Neurology, Barts and The London
School of Medicine and Dentistry and Barts Health NHS Trust: “The realisation that
multiple sclerosis affects cognition very early on in the course of the disease, before
physical disability becomes apparent, stresses the importance of treatments that don't just
reduce relapses and new lesion formation on MRI but which also reduce accelerated brain
volume loss. It is therefore very reassuring to note that people with highly-active relapsingGIL15-E003
Date of preparation: April 2015
remitting MS are nearly six times more likely to achieve NEDA4 on fingolimod compared
to placebo. NEDA4 is new treatment target of no evident disease activity that incorporates
‘normalised’ brain volume loss as its fourth component, in addition to relapse reduction,
MRI and disability progression."
The results from this new analysis confirmed:1
 20.5% of patients treated with fingolimod (n=218) achieved NEDA4 status compared
to 3.9% in the placebo group (n=229)
 Comparing between the two treatment arms, the odds ratio for achieving NEDA4
status was 6.35 (95%CI 3.02, 13.35) favouring fingolimod (p<0.0001)
The concept of NEDA is well established in other conditions such as rheumatoid arthritis,
where the aim is to treat people as soon as possible after diagnosis to prevent a build-up
of symptoms, rapidly switching to more effective drugs when there is no response to first
line treatments.2
The new analysis presented at AAN follows a series of recent decisions by the European
Commission, Scottish Medicines Consortium (SMC) and NHS England to extend the use
of fingolimod to a wider group of people since its original licence in 2011.3,4,5
To date, more than 100,000 people worldwide have been treated with fingolimod in clinical
trials and in the post-marketing setting. Fingolimod has been approved in 80 countries.6
-ENDS-
Notes to editors
 MS is the most common neurological condition affecting young adults in the UK
 It is estimated that 100,000 people in the UK have MS - relapsing remitting MS
(RRMS) is the most common form, affecting 85% of people7,8
 On 9 June 2014, the European Commission recommended the expanded use of
fingolimod for adult patients with highly active relapsing remitting multiple sclerosis3
o The indication expansion gave clinicians the flexibility to use fingolimod in
patients needing to switch from interferons as well as glatiramer acetate and
other disease modifying treatments (DMTs)
o Prior to the indication expansion, fingolimod was limited for use in those
patients with highly active RRMS not responding to an interferon
 On 18 June 2014, NHS England published new guidance to allow a switch to
fingolimod for those patients with highly active RRMS who meet the following criteria:4
o Patients who have an unchanged or increased relapse rate or ongoing severe
relapses compared with the previous year despite treatment with beta
interferon or glatiramer acetate
o As an alternative to monthly infusion natalizumab for those patients receiving
natalizumab who are at high risk of developing progressive multifocal
leukoencephalopathy (PML) as defined by the following:
- JCV exposure indicated by anti-JCV antibody positive status
- Receiving an immunosuppressant prior to receiving natalizumab
- Natalizumab treatment duration of >2 years
 On 13 October 2014, the Scottish Medicines Consortium (SMC) recommended
expanded use of fingolimod for people with a severe form of relapsing remitting
multiple sclerosis - known as rapidly evolving severe relapsing remitting MS (RES
RRMS). This was the first time an oral treatment was made available as a first line
treatment option for people with this severe form of MS9
GIL15-E003
Date of preparation: April 2015

On 14 April 2015, the Scottish Medicines Consortium (SMC) recommended the
expanded use of fingolimod to people with high disease activity despite treatment with
at least one disease modifying therapy.5
About Novartis
Novartis provides innovative healthcare solutions that address the evolving needs of
patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified
portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic
pharmaceuticals, preventive vaccines, over-the-counter and animal health products.
Novartis is the only global company with leading positions in these areas. In 2013, the
Group achieved net sales of USD 57.9 billion, while R&D throughout the Group amounted to
approximately USD 9.9 billion (USD 9.6 billion excluding impairment and amortization
charges). Novartis Group companies employ approximately 135,000 full-time-equivalent
associates and sell products in more than 150 countries around the world. For more
information, please visit http://www.novartis.com.
References
1. De Stefano N et al. Impact of fingolimod on achieving no evidence of disease activity and
worsening (NEDA)-4 in previously treated patients with high disease activity. Poster presented
at: 67th AAN Annual Meeting; April 18 – 25, 2015; Washington, DC. Poster Session III, P3.246.
2. No evidence of disease activity (NEDA) - new treatment goal. Last accessed April 2015.
http://www.mstrust.org.uk/news/article.jsp?id=5893.
3. European Commission. Community register of medicinal products for human use. Gilenya.
http://ec.europa.eu/health/documents/community-register/html/h677.html Last accessed 10
October 2014.
4. NHS England commissioning guideline for Gilenya. June 2014
5. Fingolimod guidance
https://www.scottishmedicines.org.uk/SMC_Advice/Advice/1038_15_fingolimod_Gilenya/fingoli
mod_Gilenya
6. Gilenya World Watch. http://www.gilenya-world-watch.com/English.html Last accessed 10
October 2014
7. MS Society website. http://www.mssociety.org.uk/what-is-ms/information-about-ms/about-ms.
Last accessed April 2014
8. MS Society website http://www.mssociety.org.uk/what-is-ms/types-of-ms/relapsing-remittingrrms Last accessed April 2015
9. SMC assessment of fingolimod (as hydrochloride), 0.5mg hard capsules (Gilenya®). October
2014.
Novartis Media Relations
Media contacts
Tessa Lush
Novartis Pharmaceuticals UK Ltd.
Tel: +44 1276 698 691 (Press Office)
Email: press.office@novartis.com
GIL15-E003
Siân Hurst
Aurora Healthcare Communications
Tel: +44 7949 733 493
Email: FTYteam@auroracomms.com
Date of preparation: April 2015