Genentech Gains FDA Approval for New Subcutaneous Formulation of Actemra®
for Use in Adult Patients Living With Moderately to Severely Active
*This is the sixth FDA approval for Actemra in four years, following
previous approvals for the treatment of adults with moderately to severely
active rheumatoid arthritis and children two years of age and older with
active polyarticular juvenile idiopathic arthritis and systemic juvenile
*Actemra is now approved as a subcutaneous formulation to treat adult
patients with moderately to severely active rheumatoid arthritis who have
used one or more disease-modifying antirheumatic drugs, such as
methotrexate, that did not provide enough relief.
*Actemra is the first and only humanized interleukin-6 receptor-antagonist
monoclonal antibody approved by the FDA for both subcutaneous and
intravenous administration in rheumatoid arthritis.
SOUTH SAN FRANCISCO, Calif. -- October 21, 2013
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today
announced that the U.S. Food and Drug Administration (FDA) has approved a
subcutaneous (SC) formulation of Actemra^® (tocilizumab) for the treatment of
adults with moderately to severely active rheumatoid arthritis (RA) who have
used one or more disease-modifying antirheumatic drugs (DMARDs), such as
methotrexate (MTX), that did not provide enough relief. Like the intravenous
(IV) formulation, the SC formulation can be used both as a single-agent
therapy and in combination with MTX or other non-biologic DMARDs. The Actemra
pre-filled syringe (PFS) injection formulation will be available in November.
“People with moderately to severely active rheumatoid arthritis can suffer
irreversible joint damage that may be prevented by earlier treatment with a
medicine such as Actemra,” said Hal Barron, M.D., chief medical officer and
head, Global Product Development. “We're pleased that these patients will now
have the option of Actemra as a subcutaneous injection or an IV infusion.”
Actemra, originally approved by the FDA as an IV medicine in 2010, is the
first and only humanized interleukin-6 (IL-6) receptor-antagonist monoclonal
antibody approved by the FDA for both SC and IV administration.
“Because some patients prefer a subcutaneous injection, it is important for
physicians to have this new option,” said Alan J. Kivitz, M.D., FACR,
President of Altoona Center for Clinical Research, Duncansville, Pa.^1 “In
clinical trials, Actemra was shown to be effective and have a consistent
safety profile – with the exception of injection site reactions for the
subcutaneous formulation – when administered either intravenously or
subcutaneously and may be used with or without methotrexate.”
The approval is based on data from the Phase III clinical trials SUMMACTA and
BREVACTA. For Actemra SC, the FDA recommended dosage is 162 mg administered
subcutaneously every other week, followed by an increase to 162 mg every week
based on clinical response for patients less than 100 kg (220 lbs) in weight.
For patients at or above 100 kg (220 lbs), the dosing is 162 mg administered
subcutaneously every week.
SUMMACTA is a randomized, double-blind, active-controlled, parallel-group,
multicenter study with a double-blind period of 24 weeks in 1,262 patients
with moderately to severely active RA. SUMMACTA demonstrated comparable
efficacy (non-inferiority) of the SC formulation of Actemra 162 mg given
weekly plus DMARDs compared to 8 mg/kg of Actemra given intravenously every
four weeks plus DMARDs in patients with moderately to severely active RA in
the DMARD-IR population (20 percent of whom had inadequate response to
anti-tumor necrosis factor [anti-TNF] therapy). A similar proportion of RA
patients in each group experienced at least a 20 percent improvement in tender
and swollen joints (American College of Rheumatology [ACR] 20 response) at
Week 24 (69 percent with Actemra SC formulation vs. 73 percent with Actemra
Analysis of safety at Week 24 showed that the adverse event profile of the SC
and IV groups were comparable, except for SC injection site reactions.
BREVACTA is a randomized, double-blind, parallel-group study of Actemra SC
versus placebo SC in combination with traditional DMARDs in patients with
moderately to severely active RA who had an inadequate response to DMARD
therapy. In the study, 656 patients were randomly assigned in a 2:1 ratio to
two treatment groups receiving Actemra SC every two weeks administered with a
PFS and placebo SC every two weeks with a PFS. All patients continued their
background DMARD therapy.
Results from BREVACTA showed RA patients who received the SC formulation of
Actemra every two weeks plus DMARDs were significantly more likely to have
achieved ACR20 response than those given placebo SC plus DMARDs at 24 weeks
(61 percent vs. 32 percent, respectively). At Week 24, significantly less
structural joint damage progression was observed in patients receiving Actemra
SC plus DMARDs compared to placebo plus DMARDs as assessed radiographically
and expressed as a change from baseline in the van der Heijde modified total
Sharp score (mTSS) (mean change from baseline in mTSS of 0.62 vs. 1.23,
respectively, with an adjusted mean difference of -0.60 [-1.1, -0.1]). No new
clinically meaningful safety signals for Actemra, except SC injection site
reactions, were observed in this study.
ACR20 score represents a 20 percent reduction in tender and swollen joint
counts in addition to a corresponding improvement in three of the following
*Acute phase reactant (such as erythrocyte sedimentation rate)
*Patients Global Assessment of Disease Activity
*Physicians Global Assessment of Disease Activity
*Health Assessment Questionnaire (HAQ)
About Rheumatoid Arthritis
RA is an autoimmune disease estimated to affect approximately 1.3 million
adults in the United States.^2 Joints become chronically inflamed, painful and
swollen, and patients can become increasingly disabled as cartilage and bone
About Actemra^® (tocilizumab)
Actemra is the first humanized interleukin-6 (IL-6) receptor antagonist
approved for the treatment of adult patients with moderately to severely
active rheumatoid arthritis (RA) who have used one or more disease-modifying
antirheumatic drugs (DMARDs), such as methotrexate (MTX), that did not provide
enough relief. The extensive Actemra RA IV clinical development program
included five Phase III clinical studies and enrolled more than 4,000 people
with RA in 41 countries, including the United States. The Actemra RA SC
clinical development program included two Phase III clinical studies and
enrolled more than 1,800 people with RA in 33 countries, including the United
States. In addition, Actemra is also used as an IV formulation for patients
with active polyarticular juvenile idiopathic arthritis (PJIA) or systemic
juvenile idiopathic arthritis (SJIA) two years of age and older.
Actemra is intended for use under the guidance of a healthcare practitioner.
Important Safety Information
Actemra can cause serious side effects. Actemra changes the way a patient’s
immune system works. This can make a patient more likely to get infections or
make any current infection worse. Some people taking Actemra have died from
Actemra can cause other serious side effects. These include:
*changes in blood test results, including low neutrophil (white blood
cells) and platelet (platelets help the blood to clot) counts, and
increases in certain liver function test levels and blood cholesterol
*an increased risk of certain cancers by changing the way a patient’s
immune system works
*hepatitis B infection
*serious allergic reactions, including death. These may happen with Actemra
infusions or injections, even if they did not occur with an earlier
infusion or injection.
*nervous system problems
Patients must tell their doctor if they are allergic to Actemra or if they
have had a bad reaction to Actemra previously.
Common side effects:
Patients must tell their doctor if they have these or any other side effect
that bothers them or does not go away:
*Upper respiratory tract infections (like common cold and sinus infections)
*Increased blood pressure (also called hypertension)
*Injection site reactions
Actemra & pregnancy:
Patients must tell their doctor if they are planning to become pregnant, are
pregnant, plan to breast-feed, or are breast-feeding. The patient and their
doctor should decide if the patient will take Actemra or breast-feed. Patients
should not do both. If a patient is pregnant and taking Actemra, they must
join the pregnancy registry. To learn more, patients should call
1-877-311-8972 or talk to their doctor to register.
Patients must tell their doctor right away if they are experiencing any side
effects. Report side effects to the FDA at 1-800-FDA-1088 or
www.FDA.gov/medwatch. Call Genentech at 1-888-835-2555.
Please visit www.actemra.com for the full Prescribing Information, including
Boxed Warning and Medication Guide, for additional Important Safety
Information or call 1-800-ACTEMRA (228-3672).
Actemra is part of a co-development agreement with Chugai Pharmaceutical Co.
and has been approved in Japan since June 2005. Actemra is approved in the
European Union, where it is known as RoActemra, and several other countries,
including China, India, Brazil, Switzerland and Australia.
About Genentech Access Solutions
Genentech is committed to people having access to its medicines. Genentech
Access Solutions is a team of more than 350 Genentech employees who help those
who need medications. Knowledgeable and experienced specialists can help
patients and medical practices navigate the access and reimbursement process
and provide assistance to eligible patients in the United States who do not
have insurance coverage or who cannot afford their out-of-pocket co-pay costs.
For more information, please visit http://www.GenentechAccessSolutions.com.
Founded more than 35 years ago, Genentech is a leading biotechnology company
that discovers, develops, manufactures and commercializes medicines to treat
patients with serious or life-threatening medical conditions. The company, a
member of the Roche Group, has headquarters in South San Francisco, Calif. For
additional information about the company, please visit http://www.gene.com.
1. Barton, Jennifer. Patient Preferences and Satisfaction in the Treatment of
Rheumatoid Arthritis with Biologic Therapy. Patient Preference and Adherence.
2009; 3: 335-344. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2792871/.
Accessed July 19, 2013.
2. Arthritis Foundation. Available at: http://www.arthritis.org. Accessed July
Chris Vancheri, 650-467-6800
Thomas Kudsk Larsen, 650-467-2016
Karl Mahler, 011 41 61 687 8503
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