Estimating the Impact of Oral MS Agents

A new Sermo Event™ Report polled 300 US Neurologists to assess physician perception of FDA’s “refuse to file” (RTF) letter on EMD Serono’s Cladribine tablets and its impact, if any, on Novartis’ oral MS agent in development; Fingolimod. Cladribine is expected to be one of the first oral agents to be approved for the treatment of relapsing and remitting multiple sclerosis.

According to the report, most Neurologists are optimistic for an oral MS agent and believe Cladribine will be approved. Physicians also indicate that patients are eagerly awaiting an oral agent even if it comes with higher side effects. However, the majority of Neurologists express the need for more long-term safety data and are apprehensive to increase adoption after deaths from PML associated with Tysabri.

Highlights of key findings include:

• The opportunity for oral MS drugs remains significant. Patients are aware of both new agents and are asking about their progress.
• Success at promoting early adoption of both drugs will likely be driven by educating physicians around safety profiles.
• Neurologists are closely following the clinical trials and appear to distinguish between Fingolimod and Cladribine.

The report covers a variety of areas, including:

• Anticipated physician prescribing and usage patterns.
• Physician perception of the RTF letter on Cladribine and the impact, if any, on Fingolimod.
• Necessary safety-data required by physicians before adopting Cladribine.

If approved, would you prescribe cladribine at launch?