Novartis announced that it filed its oral multiple sclerosis drug fingolimod with the FDA and European

Medicines Agency last month, and that Phase III data from two trials that were submitted in support of the applications were published in the NEJM on Wednesday.

The journal also published previously released findings from a study of Merck KGaA's oral drug cladribine. The results indicated that both drugs were effective at reducing relapses in patients with relapsing-remitting MS, however those taking the experimental compounds were also likely to have a higher risk of serious adverse events, including herpes infections.

The one-year TRANSFORMS study involved 1292 patients with relapsing-remitting MS who were randomised to receive one of two dosages of fingolimod daily, or Biogen Idec's Avonex (interferon beta-1a) once per week. Data showed that the annualised relapse rate was significantly lower in both groups receiving fingolimod, compared with the Avonex arm.

The NEJM also published full results from the two-year, placebo-controlled FREEDOMS trial of fingolimod, following Novartis' presentation of initial results in September. The trial involved 1272 patients with relapsing-remitting MS who received either one of two dosages of Novartis' oral drug daily, or placebo.

Data from the two-year, 1326-patient CLARITY study of Merck's cladribine, which were presented at a conference last April, showed that patients with relapsing-remitting MS who took either of two dosages of the investigational drug had a significantly lower annualised relapse rate, compared with those who received placebo. Each of cladribine arms was about half as likely to suffer a relapse, compared with the placebo group, data showed.

In an editorial in the journal, neurologist William Carroll wrote that "the studies...provide a new horizon for patients with relapsing-remitting multiple sclerosis and a welcome increase in the range of treatment options." He stated that both drugs are likely to be at least as effective as currently available injected therapies

.

Regarding the regulatory filings of fingolimod, Novartis' head of global drug development, Trevor Mundel, commented that he believes "almost certainly" that Novartis will have the first oral therapy to be approved in the US.

The FDA refused to accept Merck's cladribine filing in November, and the head of Merck's drug unit, Elmar Schnee, recently remarked that the agency had concerns about "tabulation" of the data that were included in the filing documents.