TITUSVILLE - The Janssen Pharmaceutical Companies of
Ponesimod is an investigational selective sphingosine-1-phosphate receptor 1 (S1P1) modulator that inhibits S1P protein activity and in so doing is believed to reduce the number of circulating lymphocytes that can cross the blood-brain barrier. In patients with MS, the movement of immune cells into the brain damages myelin, the protective sheath that insulates nerve cells. Damage to myelin slows or halts nerve conduction, producing the neurologic signs and symptoms of MS.i
'Nearly 1 million people over the age of 18 in the
The NDA is based on the head-to-head OPTIMUM Phase 3 study, which showed superior efficacy of ponesimod 20 mg on the primary endpoint of reduced annualized relapse rate (ARR), as well as most secondary endpoints, compared to Aubagio (teriflunomide) 14 mg in adults with relapsing MS.
At week 108, a highly statistically significant reduction of 30.5 percent on ARR was observed with ponesimod when compared to Aubagio. Additionally, a statistically significant reduction of fatigue symptoms and a 56 percent reduction on combined unique active lesions (CUALs) in the brain were observed with ponesimod compared to Aubagio. The safety profile observed for ponesimod was consistent with previous studies of ponesimod and the known safety profile for other S1P receptor modulators.
'What's interesting about MS is that symptoms are not always visible. Fatigue is one of the most common and debilitating symptoms of MS and yet, it's one of the most challenging to manage and treat,' said
The clinical study data that supports this filing was presented in
About Multiple Sclerosis (MS)
MS is a chronic autoimmune inflammatory disease of the central nervous system affecting 2.3 million people worldwide,iv with females more impacted than males.v The disease is characterized by demyelinationii and axonal loss leading to neurological impairment and severe disability.vi Relapsing forms of MS, which make up 85 percent of all MS cases, include clinically isolated syndrome, relapsing-remitting MS and active secondary progressive MS.vii In addition to the debilitating neurological symptoms of the disease, patients often also suffer from 'hidden symptoms,' namely fatigue and depression, both of which are major contributors to the reduced quality of life.viii Fatigue is one of the most common symptoms of MS, occurring in about 80 percent of people.ix
Relapses are defined as new, worsening or recurrent neurological symptoms that last for more than 24 hours with the absence of fever or infections. Relapses may be fully resolved over days or weeks or lead to persistent residual deficits and accumulation of disability.x
About the Janssen Pharmaceutical Companies of
At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of
Cautions Concerning Forward-Looking Statements
This press release contains 'forward-looking statements' as defined in the Private Securities Litigation Reform Act of 1995 regarding ponesimod. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of
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