Novartis’ bid to be the first firm to launch an oral treatment for multiple sclerosis has received a huge boost after a US advisory panel gave its backing to approval for fingolimod.

The US Food and Drug Administration’s Peripheral and Central Nervous System Drugs Advisory Committee has recommended approval of fingolimod, also known as FTY720 for the treatment of relapsing MS. The panel voted unanimously, 25 to 0, that fingolimod is safe and effective and then 21 to 3 (one member of the committee had to leave the meeting) that the drug could be used as a first-line treatment for MS. However the FDA had earlier rejected Novartis’ proposed name for the drug which was Gilenia.

The safety profile of FTY720 includes more than 4,500 patient years of experience, Novartis said, with some patients in their seventh year of treatment. In Phase III studies adverse events included transient, dose-related, generally asymptomatic heart rate reduction, blood pressure increase and macular oedema. A slight increase in lung infections (primarily bronchitis) was seen in patients treated with FTY720.

The committee recommended post-marketing collection of additional safety data and evaluation of a lower dose than the 0.5mg Novartis is proposing. However panellists said these studies do not need to be carried out before approval.

Trevor Mundel, head of R&D at Novartis Pharma, said the committee's positive vote affirms the favourable benefit/risk profile of FTY720 and “we will work closely with the FDA as it finalises its review of our New Drug Application”. He added that, if approved, fingolimod will “offer patients an effective treatment in the convenience of a pill and we look forward to making this innovative therapy available”.

FTY720 is the first in a new class of therapies called sphingosine1-phosphate receptor modulators, which work by retaining certain immune cells in the lymph nodes, preventing them from reaching the central nervous system and causing damage. Novartis noted that this lymphocyte retention is reversible, “allowing circulating lymphocytes to regain normal levels if treatment is stopped”.

MS experts seem happy with the panel’s recommendation, and Robert Lisak of the Wayne State University School of Medicine in Detroit, said “I would welcome having another treatment option for my patients, particularly an oral medication that might make it easier for people to get on and stay on therapy”. He added that taking a disease-modifying therapy “is the best way we have of reducing MS disease activity and future deterioration…however, we will need to monitor all new therapies for any long-term safety issues”.

Novartis’ share price is on the rise this morning and was up 3.5% to 55.75 Swiss francs at 10.30am (UK time). Investors clearly believe that the company is going to be the first to launch an MS pill, seeing as how Novartis’ main competitor, Merck KGaA, has only just resubmitted its pill, cladribine, with the FDA, seven months after receiving a 'refuse to file' letter from the agency.