April 23, 2018
· Four years of continuous treatment with OCREVUS showed a sustained reduction in underlying disease activity in relapsing MS (RMS) in analysis from the open-label extension period
· Additional analyses show OCREVUS delayed cognitive decline and improved cognitive function in RMS, as measured by Symbol Digit Modalities Test
· OCREVUS reduced the presence of nerve damage and inflammation biomarkers in people with RMS shown in interim data from a Phase III study
· New safety data are consistent with OCREVUS’ favorable benefit-risk profile for both RMS and primary progressive MS
· Over 40,000 patients treated with OCREVUS globally
SOUTH SAN FRANCISCO, Calif. – April 23,
2018 – Genentech, a
member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that
new OCREVUS (ocrelizumab) data were presented at the 70th
American Academy of Neurology (AAN) Annual Meeting from April 21-27 in Los
Angeles, California. The data
showcase the efficacy of OCREVUS in relapsing multiple sclerosis (RMS) through
several measures of underlying disease activity and disability progression,
including magnetic resonance imaging (MRI), cognitive function, and spinal
fluid biomarkers of inflammation and neurodegeneration. New safety data
remain consistent with OCREVUS’ favorable benefit-risk profile in both
relapsing and primary progressive multiple sclerosis (PPMS).
2018 – Genentech, a
member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that
new OCREVUS (ocrelizumab) data were presented at the 70th
American Academy of Neurology (AAN) Annual Meeting from April 21-27 in Los
Angeles, California. The data
showcase the efficacy of OCREVUS in relapsing multiple sclerosis (RMS) through
several measures of underlying disease activity and disability progression,
including magnetic resonance imaging (MRI), cognitive function, and spinal
fluid biomarkers of inflammation and neurodegeneration. New safety data
remain consistent with OCREVUS’ favorable benefit-risk profile in both
relapsing and primary progressive multiple sclerosis (PPMS).
“The OCREVUS
data shared at AAN show the impact of this targeted B cell therapy on slowing
disability progression in MS, and further support the approach of early
treatment. In the extension studies, patients who received OCREVUS continuously
experienced less disease progression than those who began treatment at a later
time point,” said Stephen Hauser, M.D., chair of the Scientific Steering
Committee of the OPERA studies, director of the Weill Institute for
Neurosciences and chair of the Department of Neurology at the University of
California, San Francisco. “It is encouraging that with up to four years of
data, we continue to see a robust effect and a consistent safety profile.”
data shared at AAN show the impact of this targeted B cell therapy on slowing
disability progression in MS, and further support the approach of early
treatment. In the extension studies, patients who received OCREVUS continuously
experienced less disease progression than those who began treatment at a later
time point,” said Stephen Hauser, M.D., chair of the Scientific Steering
Committee of the OPERA studies, director of the Weill Institute for
Neurosciences and chair of the Department of Neurology at the University of
California, San Francisco. “It is encouraging that with up to four years of
data, we continue to see a robust effect and a consistent safety profile.”
After four years
of continuous treatment, the benefits of OCREVUS in reducing underlying disease
activity in RMS were sustained, as shown in a platform presentation measuring
brain MRI activity through the randomized and open-label extension (OLE) periods
of the Phase III studies. Patients who stayed on OCREVUS maintained low numbers
of T1 gadolinium-enhancing (T1Gd+) lesions (0.017 pre-OLE to 0.17 T1Gd+ lesions
per scan at year four [year two of the OLE phase]) and new/enlarging T2 (N/ET2)
lesions [0.052 pre-OLE to 0.080 N/ET2 lesions per scan] through year two of the
OLE phase. Patients who switched from Rebif® (interferon beta-1a) to
OCREVUS at the start of the OLE period had a near-complete silencing of T1Gd+
lesions per scan at one and two years (0.476 pre-OLE to 0.007 and 0.004 T1Gd+
lesions per scan), as well as an 85 and 97 percent decrease in N/ET2 lesions
per scan at years one and two, respectively (2.159 pre-OLE to 0.333 and 0.063
N/ET2 lesions per scan).
of continuous treatment, the benefits of OCREVUS in reducing underlying disease
activity in RMS were sustained, as shown in a platform presentation measuring
brain MRI activity through the randomized and open-label extension (OLE) periods
of the Phase III studies. Patients who stayed on OCREVUS maintained low numbers
of T1 gadolinium-enhancing (T1Gd+) lesions (0.017 pre-OLE to 0.17 T1Gd+ lesions
per scan at year four [year two of the OLE phase]) and new/enlarging T2 (N/ET2)
lesions [0.052 pre-OLE to 0.080 N/ET2 lesions per scan] through year two of the
OLE phase. Patients who switched from Rebif® (interferon beta-1a) to
OCREVUS at the start of the OLE period had a near-complete silencing of T1Gd+
lesions per scan at one and two years (0.476 pre-OLE to 0.007 and 0.004 T1Gd+
lesions per scan), as well as an 85 and 97 percent decrease in N/ET2 lesions
per scan at years one and two, respectively (2.159 pre-OLE to 0.333 and 0.063
N/ET2 lesions per scan).
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