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Posted by on Jan 26, 2009 in Neurology, Pharma

The MS Holy Grail: It’s a Horse Race for FDA Submission of Oral Agent

The MS Holy Grail: It’s a Horse Race for FDA Submission of Oral Agent


Something to blog about other than the Pfizer-Wyeth merger/acquisition:

Merck KGaA and its Merck Serono division will submit phase 3 data to the FDA in mid-2009 for the fast-track approval of oral cladribine in patients with relapsing-remitting multiple sclerosis (RRMS). The companies issued a press release on Friday, describing favorable 2-year data from an extension phase of a pivotal phase 3 trial, CLARITY.

In the 2-year, randomized, double-blind international study (N = 1326), the annualized relapse rate (the primary endpoint) with various cladribine regimens was approximately 60% lower than that with placebo (P < .001). Secondary endpoints of the study, including a reduction of MRI lesion activity, relapse-free rates, and disability progression were also significantly lower with cladribine.

Cladribine-specific adverse events included the expected lymphopenia. In addition, 4 cases of cancerearly-stage cervical, melanoma, ovarian, and pancreaticoccurred in RRMS patients who received cladribine, reports today’s Bloomberg. Nevertheless, completion rates in the study were very high: 90% of cladribine-treated patients and 87% of placebo-treated patients.

Currently available, FDA-approved disease-modifying medications for RRMS must be administered by injection. These include a subcutaneous formulation of interferon beta for multiple sclerosis, Rebif, which is marketed by Merck Serono. Cladribine, a purine analog, has been marketed as the injectable Leustatin by Ortho-Biotech since 1993 for the treatment of hairy cell leukemia. Nonproprietary formulations are available from Bedford and Abraxis, according to the FDA web site.

Novel oral compounds in phase 3 development for MS include fumerate (Fumaderm or BG-12; Biogen Idec), fingolimod (Novartis), laquinimod (Teva), and teriflunomide (sanofi-aventis).

CLARITY = CLAdribine Tablets Treating MS OrallY.

bmartin (1127 Posts)

A native East Tennessean, Barbara Martin is a formerly practicing, board-certified neurologist who received her BS (psychology, summa cum laude) and MD from Duke University before completing her postgraduate training (internship, residency, fellowship) at the Hospital of the University of Pennsylvania in Philadelphia. She has worked in academia, private practice, medical publishing, drug market research, and continuing medical education (CME). For the last 3 years, she has worked in a freelance capacity as a medical writer, analyst, and consultant. Follow Dr. Barbara Martin on and Twitter.