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Friday, April 18, 2014 1:27 AM | MS Karen Volg link

Slowing Down Primary Progressive Multiple Sclerosis Disability Progression Worth Safety Risks For New Drugs, Say Surveyed U.S. Neurologists




Photo Credit: Designua/Shutterstock

Photo Credit: Designua/Shutterstock



According to a recent wide-ranging survey among U.S.0based neurologists who treat Multiple Sclerosis, the consensus among the physicianpopulation is that doctors would be willing to accept a certain level of risk in new therapies for treating Primary Progressive Multiple Sclerosis if the drugs were proven to effectively reduce disability progression.


The survey, Chronic-Progressive Multiple Sclerosis: Amid Substantial Unmet Need, What Magnitude of Efficacy and Safety Do Neurologists and Payers Expect of a First-To-Market Therapy for Primary-Progressive Multiple Sclerosis?, which was conducted by Decision Resources Group (DRG) using a proprietary conjoint analysis tool, revealed that, among hypothetical therapies assessed in the study, neurologists are clearly calling for newtherapeutic alternatives to Teva’s Copaxone. While Copaxone is often used by doctors as a therapy for Primary Progressive Multiple Sclerosis (PPMS), the neurologists implied in their responses that they would trade the safety of Copaxone for a new drug that features improved efficacy in treating the disease progression, even if there are increased life-threatening health risks associated with a new drug. 


The new insights reveal that there continues to be significant unmet needs in drug development for types of MS other than its most common form, relapsing-remitting, which features a collection of disease modifying and interferon-based drugs commonly used to slow down its progression into secondary progressive multiple sclerosis (SPMS). PPMS differs from relapsing-remitting, in that those who develop PPMS from the onset of being diagnosed with Multiple Sclerosis see a steady, constant acceleration of symptoms and brain atrophy, as opposed to the “ups and downs” associated with relapsing-remitting. Because the progression of symptoms and rapid loss of quality of life in PPMS is so palpable, that doctors are seeking out new ways to slow down the disease’s progression for their patients.


For their part, Teva would appear to agree, in that the drug maker is currently working on an emerging MS treatment called Nerventra — a promising Multiple Sclerosis treatment that, while not yet studied in PPMS patients, shows enough preliminary efficacy that the neurologists surveyed in the DGR study say that the drug would find application in 24 percent of the currently treated PP-MS patient population. The particular interest in Nerventra stems from the fact that the drug offers a key ingredient in treating Multiple Sclerosis — a putative neuroprotective effect — and has also shown a benign safety profile to date. Together with a patient-friendly once-daily oral administration, medical practitioners are clearly seeing it as a potential next-generation therapy for primary progressive Multiple Sclerosis.



Emma McFadden, Ph.D., an analyst for Decision Resources Group, commented that, “Data suggest that surveyed U.S. managed care organization pharmacy directors are highly receptive to novel PP-MS therapies offering even modest improvements over Copaxone on disability progression. However, they are sensitive to the risk profile of such agents when making formulary decisions, with few willing to reimburse a therapy with greater than one percent risk of serious adverse events. This reluctance is likely owing to the high costs which can be incurred by riskier therapies, such as by the need for patient monitoring and potential hospitalization.” Dr. McFadden went on to add that, “If proven effective in their respective ongoing PP-MS clinical trials, Novartis’s Gilenya and Roche/Genentech’s ocrelizumab both have considerable market potential. Even prior to the availability of PP-MS clinical data, surveyed U.S. neurologists indicate that they would prescribe these therapies to 20 percent of their currently treated PP-MS patients.”


Given this key finding among the neurology community, it stands to reason that drug developers such as Teva will move as quickly as possible to find new, viable treatments to curtail the progression of PPMS.