John Walsh, MD, on the FDA Acceptance of NDA for Cladribine Tablets for MS


The vice president of US Medical Affairs in Neurology & Immunology at EMD Serono discussed the potential for the oral multiple sclerosis therapy.

Dr John Walsh

John Walsh, MD, the vice president of US Medical Affairs in Neurology & Immunology at EMD Serono

John Walsh, MD

On July 30, the FDA accepted a New Drug Application (NDA) for cladribine tablets for the treatment of patients with relapsing forms of multiple sclerosis (MS).

This news came 7 years after the agency sent a Complete Response Letter to the therapy’s developer, EMD Serono, citing a lack of data informing the FDA about the safety risks and overall risk-benefit profile. Since, the therapy has received approval in a multitude of countries, tallying 38 total approvals as of the NDA.

Now, across a group of studies supplementing the new application, the therapy was shown to reduce the rate of annualized relapse, increase the relapse-free rate, reduce the risk of clinically definite MS, and reduce the risk of relapse in patients already being treated with interferon ß.

In total, the clinical trial program in which the therapy was assessed consisted of 5 studies: the phase II CLARITY, CLARITY EXT, and ORACLE studies; the phase II ONWARD study; and the long-term follow-up PREMIERE trial. The program included 12,000 patient-years of data from more than 2700 patients, with a total of follow-up of up to 10 years for some patients.

In an exclusive interview with NeurologyLive, John Walsh, MD, the vice president of US Medical Affairs in Neurology & Immunology at EMD Serono, noted that the company is looking forward to working with the FDA to possibly bring this investigational treatment to patients and physicians in the United States.

NeurologyLive: What do these cladribine tablets offer patients—and physicians—that makes them a better option?

John Walsh, MD: While there are a number of treatments currently approved for relapsing forms of MS, treatment options with infrequent oral dosing regimens are limited. If approved, cladribine tablets would offer appropriate patients a relatively short-term (for a maximum of 20 days of dosing over 2 years) oral dosing option, which may help lower the treatment burden for patients.

Could you reflect on some of the key data from the phase III program investigating cladribine? Are there any takeaways or focus points that perhaps haven’t been given the attention they could be?

JW: Cladribine tablets were studied in a 2-year placebo-controlled study—CLARITY&mdash;where a relative reduction of 58% was observed for the annualized relapse rate vs. placebo (P <.001) and a 90% relative reduction in the mean number of T1 Gd+ lesions after 96 weeks.

Lymphopenia was the most common adverse event, occurring in 20% of patients in the CLARITY trial.

What sort of needs could be met by this treatment for patients with MS, and are there patients you believe would benefit the most?

JW: Because MS is a highly complex disease, there is still a need for additional treatment options, and EMD Serono is committed to researching new therapeutic options that may benefit people with different needs and at different points in their treatment journey. If approved, Cladribine tablets could be an additional oral treatment option offering a potential new treatment paradigm for patients with relapsing forms of MS.

Is there anything else that neurologists should know about this therapy?

JW: Most available MS therapies require continued, regular dosing of the medication. Cladribine tablets have a proposed dosing of a maximum of 20 days over 2 years with no additional dosing required in years 3 and 4.


FDA Accepts File for Cladribine Tablets as Potential Treatment for Relapsing Forms of Multiple Sclerosis [press release]. Rockland, MA: EMD Serono; July 30, 2018. Accessed July 31, 2018.

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