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FDA approves Ocrevus (Ocrelizumab)
Tuesday, Mar 28, 2017
FDA Approves Genentech’s OCREVUS™ (Ocrelizumab) For Relapsing and Primary Progressive Forms of Multiple Sclerosis
First and only approved disease-modifying therapy for primary progressive form of multiple sclerosis (PPMS) – one of the most disabling forms of multiple sclerosis (MS).
An important new treatment option for people with relapsing forms of multiple sclerosis (RMS) demonstrating superior efficacy on the three major markers of disease activity compared with Rebif®.
A favorable benefit-risk profile demonstrated in three large Phase III studies with a diverse patient population, including those early in the disease.
South San Francisco, CA -- March 28, 2017 --
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) approved OCREVUS™ (ocrelizumab) as the first and only medicine for both relapsing and primary progressive forms of multiple sclerosis. The majority of people with MS have a relapsing form or primary progressive MS at diagnosis.
“The FDA’s approval of OCREVUS is the beginning of a new era for the MS community and represents a significant scientific advance with this first-in-class B cell targeted therapy,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “Until now, no FDA-approved treatment has been available to the primary progressive MS community, and some people with relapsing forms of MS continue to experience disease activity and disability progression despite available therapies. We believe OCREVUS, given every six months, has the potential to change the disease course for people with MS, and we are committed to helping those who can benefit gain access to our medicine.”
In two identical RMS Phase III studies (OPERA I and OPERA II), OCREVUS demonstrated superior efficacy on the three major markers of disease activity by reducing relapses per year by nearly half, slowing the worsening of disability and significantly reducing MRI lesions compared with Rebif® (high-dose interferon beta-1a) over the two-year controlled treatment period. A similar proportion of people in the OCREVUS group experienced a low rate of serious adverse events and serious infections compared with people in the high-dose interferon beta-1a group in the RMS studies.*
In a separate PPMS Phase III study (ORATORIO), OCREVUS was the first and only treatment to significantly slow disability progression and reduce signs of disease activity in the brain (MRI lesions) compared with placebo with a median follow-up of three years. A similar proportion of people in the OCREVUS group experienced adverse events and a low rate of serious adverse events compared with people in the placebo group in the PPMS study.*
The most common side effects associated with OCREVUS in all Phase III studies included infusion reactions and upper respiratory tract infections, which were mostly mild to moderate in severity. Results from these three Phase III studies were recently published in the January 19, 2017 issue of the New England Journal of Medicine (NEJM).
“This is an exciting day for everyone touched by MS, a disease that strikes in the prime of a person’s life when she or he may be starting a career or family,” said June Halper, MSN, APN-C, MSCN, FAAN, chief executive officer at the Consortium for MS Centers. “We have eagerly awaited the FDA approval of OCREVUS because it not only offers a new, highly efficacious treatment option for people with relapsing multiple sclerosis, but it is also the first disease-modifying therapy indicated for primary progressive multiple sclerosis, a highly disabling type of this chronic disease. For many people living with MS, this FDA approval is a source of hope.”
*OCREVUS will be available to people in the U.S. within two weeks. Genentech is committed to helping people access the medicines they are prescribed and will be offering comprehensive services for people prescribed OCREVUS to help minimize barriers to access and reimbursement. Patients can call 1-844-OCREVUS for more information. For people who qualify, Genentech plans to offer patient assistance programs through Genentech Access Solutions. More information is also available at (866) 4ACCESS/(866) 422-2377 or http://www.Genentech-Access.com.
The OCREVUS Marketing Authorization Application (MAA) has also been validated by the European Medicines Agency (EMA) and is currently under review.
About the OPERA I and OPERA II studies in relapsing forms of MS
OPERA I and OPERA II are Phase III, randomized, double-blind, double-dummy, global multi-center studies evaluating the efficacy and safety of OCREVUS (600 mg administered by intravenous infusion every six months) compared with interferon beta-1a (44 mcg administered by subcutaneous injection three times per week) in 1,656 people with relapsing forms of MS. In these studies, relapsing MS (RMS) was defined as relapsing-remitting MS (RRMS) and secondary progressive MS (SPMS) with relapses.
About the ORATORIO study in primary progressive MS
ORATORIO is a Phase III, randomized, double-blind, global multi-center study evaluating the efficacy and safety of OCREVUS (600 mg administered by intravenous infusion every six months; given as two 300 mg infusions two weeks apart) compared with placebo in 732 people with PPMS. The blinded treatment period of the ORATORIO study continued until all patients had received at least 120 weeks of either OCREVUS or placebo and a predefined number of confirmed disability progression (CDP) events was reached overall in the study.
A summary of the data from the OPERA I, OPERA II and ORATORIO studies that support this approval is below.
Key data in RMS patients treated with OCREVUS showed:
A 46 percent and 47 percent relative reduction in the annualized relapse rate (ARR) compared with interferon beta-1a over the two-year period in OPERA I and OPERA II, respectively (p < 0.0001 and p < 0.0001).
A 40 percent relative risk reduction in confirmed disability progression (CDP) sustained for 12 weeks compared with interferon beta-1a in a pooled analysis of OPERA I and OPERA II, as measured by the Expanded Disability Status Scale (EDSS) (p=0.0006).
A 94 percent and 95 percent relative reduction in the total number of T1 gadolinium-enhancing lesions compared with interferon beta-1a in OPERA I and OPERA II, respectively (p < 0.0001 and p < 0.0001).
A 77 percent and 83 percent relative reduction in the total number of new and/or enlarging T2 lesions compared with interferon beta-1a in OPERA I and OPERA II, respectively (p < 0.0001 and p < 0.0001).
Key data in PPMS patients treated with OCREVUS showed:
A 24 percent relative risk reduction in CDP sustained for at least 12 weeks compared with placebo, as measured by the EDSS (p=0.0321).
A -0.39 cm3 mean change in volume of brain hyperintense T2 lesions compared with a 0.79 cm3 mean change in volume of placebo-treated patients over 120 weeks (p < 0.0001).
A 25 percent relative risk reduction in the proportion of patients with 20 percent worsening of the timed 25-foot walk confirmed at 12 weeks.
The most common side effects associated with OCREVUS in all Phase III studies were infusion reactions and upper respiratory tract infections, which were mostly mild to moderate in severity. Potential serious side effects may include infusion reactions, infections and malignancies where only routine screening is required based on age and medical history.*
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FDA Approves Genentech’s OCREVUS™ (Ocrelizumab) For Relapsing and Primary Progressive Forms of Multiple Sclerosis
First and only approved disease-modifying therapy for primary progressive form of multiple sclerosis (PPMS) – one of the most disabling forms of multiple sclerosis (MS).
An important new treatment option for people with relapsing forms of multiple sclerosis (RMS) demonstrating superior efficacy on the three major markers of disease activity compared with Rebif®.
A favorable benefit-risk profile demonstrated in three large Phase III studies with a diverse patient population, including those early in the disease.
South San Francisco, CA -- March 28, 2017 --
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) approved OCREVUS™ (ocrelizumab) as the first and only medicine for both relapsing and primary progressive forms of multiple sclerosis. The majority of people with MS have a relapsing form or primary progressive MS at diagnosis.
“The FDA’s approval of OCREVUS is the beginning of a new era for the MS community and represents a significant scientific advance with this first-in-class B cell targeted therapy,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “Until now, no FDA-approved treatment has been available to the primary progressive MS community, and some people with relapsing forms of MS continue to experience disease activity and disability progression despite available therapies. We believe OCREVUS, given every six months, has the potential to change the disease course for people with MS, and we are committed to helping those who can benefit gain access to our medicine.”
In two identical RMS Phase III studies (OPERA I and OPERA II), OCREVUS demonstrated superior efficacy on the three major markers of disease activity by reducing relapses per year by nearly half, slowing the worsening of disability and significantly reducing MRI lesions compared with Rebif® (high-dose interferon beta-1a) over the two-year controlled treatment period. A similar proportion of people in the OCREVUS group experienced a low rate of serious adverse events and serious infections compared with people in the high-dose interferon beta-1a group in the RMS studies.*
In a separate PPMS Phase III study (ORATORIO), OCREVUS was the first and only treatment to significantly slow disability progression and reduce signs of disease activity in the brain (MRI lesions) compared with placebo with a median follow-up of three years. A similar proportion of people in the OCREVUS group experienced adverse events and a low rate of serious adverse events compared with people in the placebo group in the PPMS study.*
The most common side effects associated with OCREVUS in all Phase III studies included infusion reactions and upper respiratory tract infections, which were mostly mild to moderate in severity. Results from these three Phase III studies were recently published in the January 19, 2017 issue of the New England Journal of Medicine (NEJM).
“This is an exciting day for everyone touched by MS, a disease that strikes in the prime of a person’s life when she or he may be starting a career or family,” said June Halper, MSN, APN-C, MSCN, FAAN, chief executive officer at the Consortium for MS Centers. “We have eagerly awaited the FDA approval of OCREVUS because it not only offers a new, highly efficacious treatment option for people with relapsing multiple sclerosis, but it is also the first disease-modifying therapy indicated for primary progressive multiple sclerosis, a highly disabling type of this chronic disease. For many people living with MS, this FDA approval is a source of hope.”
*OCREVUS will be available to people in the U.S. within two weeks. Genentech is committed to helping people access the medicines they are prescribed and will be offering comprehensive services for people prescribed OCREVUS to help minimize barriers to access and reimbursement. Patients can call 1-844-OCREVUS for more information. For people who qualify, Genentech plans to offer patient assistance programs through Genentech Access Solutions. More information is also available at (866) 4ACCESS/(866) 422-2377 or http://www.Genentech-Access.com.
The OCREVUS Marketing Authorization Application (MAA) has also been validated by the European Medicines Agency (EMA) and is currently under review.
About the OPERA I and OPERA II studies in relapsing forms of MS
OPERA I and OPERA II are Phase III, randomized, double-blind, double-dummy, global multi-center studies evaluating the efficacy and safety of OCREVUS (600 mg administered by intravenous infusion every six months) compared with interferon beta-1a (44 mcg administered by subcutaneous injection three times per week) in 1,656 people with relapsing forms of MS. In these studies, relapsing MS (RMS) was defined as relapsing-remitting MS (RRMS) and secondary progressive MS (SPMS) with relapses.
About the ORATORIO study in primary progressive MS
ORATORIO is a Phase III, randomized, double-blind, global multi-center study evaluating the efficacy and safety of OCREVUS (600 mg administered by intravenous infusion every six months; given as two 300 mg infusions two weeks apart) compared with placebo in 732 people with PPMS. The blinded treatment period of the ORATORIO study continued until all patients had received at least 120 weeks of either OCREVUS or placebo and a predefined number of confirmed disability progression (CDP) events was reached overall in the study.
A summary of the data from the OPERA I, OPERA II and ORATORIO studies that support this approval is below.
Key data in RMS patients treated with OCREVUS showed:
A 46 percent and 47 percent relative reduction in the annualized relapse rate (ARR) compared with interferon beta-1a over the two-year period in OPERA I and OPERA II, respectively (p < 0.0001 and p < 0.0001).
A 40 percent relative risk reduction in confirmed disability progression (CDP) sustained for 12 weeks compared with interferon beta-1a in a pooled analysis of OPERA I and OPERA II, as measured by the Expanded Disability Status Scale (EDSS) (p=0.0006).
A 94 percent and 95 percent relative reduction in the total number of T1 gadolinium-enhancing lesions compared with interferon beta-1a in OPERA I and OPERA II, respectively (p < 0.0001 and p < 0.0001).
A 77 percent and 83 percent relative reduction in the total number of new and/or enlarging T2 lesions compared with interferon beta-1a in OPERA I and OPERA II, respectively (p < 0.0001 and p < 0.0001).
Key data in PPMS patients treated with OCREVUS showed:
A 24 percent relative risk reduction in CDP sustained for at least 12 weeks compared with placebo, as measured by the EDSS (p=0.0321).
A -0.39 cm3 mean change in volume of brain hyperintense T2 lesions compared with a 0.79 cm3 mean change in volume of placebo-treated patients over 120 weeks (p < 0.0001).
A 25 percent relative risk reduction in the proportion of patients with 20 percent worsening of the timed 25-foot walk confirmed at 12 weeks.
The most common side effects associated with OCREVUS in all Phase III studies were infusion reactions and upper respiratory tract infections, which were mostly mild to moderate in severity. Potential serious side effects may include infusion reactions, infections and malignancies where only routine screening is required based on age and medical history.*
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