FDA Panel Backs Novartis Drug - Analyst Blog

Recently, Novartis’ (NVS) FTY720 (fingolimod) received a favorable recommendation from an advisory committee of the US Food and Drug Administration (FDA). The drug has been developed for the treatment of patients with relapsing multiple sclerosis (MS) orally. Although the FDA is not bound to follow the panel’s recommendation, it generally does so. 

We are pleased to note that the committee unanimously concluded that FTY720 (0.5 mg) demonstrated safety and effectiveness in treating relapsing remitting MS. 

Novartis submitted the application for regulatory approval of FTY720 to the FDA and European Medicines Agency (EMA) in December 2009. The FDA granted priority review status to the drug in February 2010, which reduced the standard 10-month review period to six months (June 2010). However, since the FDA asked for an advisory committee meeting, the review process has been extended by another three months till September 2010. 

In April 2010, Novartis presented positive data for FTY720 which showed the drug’s effectiveness irrespective of the treatment history of patients. It was observed that the drug reduced annual relapse rates (ARR) by 62% in treatment naïve patients compared to placebo, and by 44% for patients who have undergone treatment. 

Another study, conducted for over a period of one year, was aimed at evaluating the efficacy of FTY720 compared to Biogen Idec’s (BIIB) Avonex (injectable). It was observed that the drug reduced relapse rates by 52% compared to Avonex. 

MS is an inflammatory and neurodegenerative condition that affects almost 2.5 million people globally. However, the market is highly competitive with the presence of products such as Biogen’s Avonex ($2.3 billion in revenues in 2009) and Tysabri ($1.1 billion), Teva’s (TEVA) Copaxone ($2.8 billion) and Merck KGaA’s (MKGAF) Rebif (€1.5 billion). 

We believe a unanimous decision from the panel and encouraging data so far might fetch Novartis the approval from the FDA. If approved, FTY720 would potentially be the first oral therapy for treating relapsing MS.
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