Gilenia cuts relapse rates in MS patients

Novartis’ new oral multiple sclerosis treatment Gilenia has been shown to reduce relapse rates significantly in new trial data.

Data presented from the FREEDOMS study at the American Academy of Neurology on 13 April showed that Gilenia (fingolimod) reduced annual relapse rates by 62% in newly treated patients and 44% in previously treated patients.
 
In addition, at two years Gilenia delayed the progression of disability by 30% for patients on 0.5 mg compared to placebo.
 
"These findings reinforce the potential for Gilenia to be a breakthrough therapy option for physicians and people with relapsing forms of MS," said Trevor Mundel, MD, global head of development at Novartis.
 
Mundel continued: "The data demonstrate the effectiveness of Gilenia irrespective of treatment history, and further support both the sustained efficacy of Gilenia over two years and the potential benefits of switching from interferon beta-1a, a currently approved MS therapy, to Gilenia."
 
Novartis has submitted the 0.5 mg dose for regulatory approval in the US and EU as results from the studies indicates that this dose has the most favourable benefit/risk profile. Applications for regulatory approval for Gilenia 0.5 mg were submitted to the FDA and the EMA in December 2009.

In February 2010, the FDA granted Gilenia ‘priority review status’. Since Gilenia involves a NME, the FDA has required an Advisory Committee meeting on 10 June that will evaluate the risk-management programme that could result in the FDA extending its review at the end of the designated six-month period in June 2010.

Novartis has said that the brand name Gilenia has been provisionally approved by the FDA for use in connection with the product, but the product itself has not received marketing authorisation or NDA approval from any regulatory authorities.

MS treatment race

This data helps consolidate Novartis’ lead over Merck Serono’s MS treatment cladribine that received a ‘refuse to file’ notice last November. Merck has stated that it may re-submit the drug to the FDA as a new drug application in the immediate future.
 
Cladribine is already a licenced drug (brand name Leustat) indicated for the treatment of leukaemia as an intravenous infusion. Merck Serono has reformulated the drug into an oral version with a different dosing pattern for relapsing and remitting MS.
 
Both are hoped to become new treatments for MS that is currently treated by interferon beta injections that can cause patients highly adverse side effects.