- Systemic sclerosis affects
approximately 75,000 to 100,000 people in the U.S. and has highest
mortality rate of any autoimmune rheumatic disease1,2
- There is no FDA-approved therapy for
the rare disease1
- Genentech initiates Phase III clinical
trial
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX:
RHHBY), today announced that the U.S. Food and Drug Administration
(FDA) has granted Breakthrough Therapy Designation status to
Actemra® (tocilizumab) for systemic sclerosis, also known as
scleroderma.1 This designation is intended to expedite the
development and review of medicines with early signals of potential
clinical benefit in serious diseases and to help ensure patients
have access to them as soon as possible. Genentech has also
initiated a Phase III study in systemic sclerosis (NCT02453256), a
disease for which there are inadequate treatment options.3,4
“The development of Actemra in systemic sclerosis represents our
commitment to severe rheumatic diseases,” said Sandra Horning,
M.D., chief medical officer and head of Global Product Development.
“This Breakthrough Therapy Designation underscores the unmet need
in systemic sclerosis and the potential of Actemra to help patients
with this debilitating autoimmune disorder.”
Actemra in systemic sclerosis
Systemic sclerosis is a rare, chronic disorder characterized by
blood vessel abnormalities, as well as degenerative changes and
scarring in the skin, joints, and internal organs.4 The disease
affects approximately 75,000 to 100,000 people in the United
States. More than 75 percent of systemic sclerosis patients are
women, primarily aged 30 to 50.1 Systemic sclerosis has the highest
mortality of any autoimmune rheumatic disease.2
There is currently no FDA-approved treatment for systemic
sclerosis. There are treatments for some aspects of this disease,
but none are used to stop or reverse the key symptom of skin
thickening and hardening.1
The Breakthrough Therapy Designation for Actemra was granted
based on data from the Phase II faSScinate study. Forty-eight week
data will be presented as an oral presentation in Rome at EULAR
2015 (abstract number: OP0054; presentation date: Thursday, June
11, 2015).5 While the primary endpoint of improvement in skin
thickening at 24 weeks – as assessed by the Rodnan skin score – was
not met, a meaningful trend was observed. In this second part of
the study, there was continued improvement in skin thickening
between weeks 24 and 48.5 The overall adverse event profile between
both groups was comparable.5 The extent and severity of skin
thickness correlates to disease worsening, increased disability and
decreased survival.6,7 Based on these Phase II results and the
unmet need in patients with systemic sclerosis, Genentech initiated
a multicenter, randomized, double-blind, placebo-controlled Phase
III trial (NCT02453256).
About Actemra
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
subcutaneous 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 these
infections.
Actemra can cause other serious side effects. These
include:
- stomach tears
- 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 levels
- 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 should tell their doctor if they are allergic to
Actemra or if they have had a bad reaction to Actemra
previously.
Common side effects:
Patients should 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)
- Headache
- Increased blood pressure (also called
hypertension)
- Injection site reactions
Actemra & pregnancy:
Patients should 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. Genentech has
a registry for pregnant women who take Actemra. The purpose of this
registry is to check the health of the pregnant mother and her
baby. If a patient is pregnant or becomes pregnant while taking
Actemra, she should talk to her healthcare provider about how she
can join this pregnancy registry or she may contact the registry at
1-877-311-8972 to enroll.
Patients should tell their doctor right away if they are
experiencing any side effects. Report side effects to the FDA at
1-800-FDA-1088 or http://www.FDA.gov/medwatch.
Call Genentech at 1-888-835-2555.
Please visit http://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
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, California.
For additional information about the company, please
visit http://www.gene.com.
References
1 The American College of Rheumatology. Scleroderma (also known
as systemic sclerosis). Available at:
https://www.rheumatology.org/Practice/Clinical/Patients/Diseases_And_Conditions/Scleroderma_(also_known_as_systemic_sclerosis).
[Last accessed: June 3, 2015]
2 Khanna D, Denton CP. Evidence-based management of rapidly
progressing systemic sclerosis. Best Pract Res Clin Rheumatol 2010;
24: 387–400.
3 Krause L, et al. Nutritional status as marker for disease
activity and severity predicting mortality in patients with
systemic sclerosis. Ann Rheum Dis. 2010; 69: 1951–1957.
4 Hajj-ali R. Merck Manuals. Systemic Sclerosis. Available at:
http://www.merckmanuals.com/home/bone-joint-and-muscle-disorders/autoimmune-disorders-of-connective-tissue/systemic-sclerosis.
[Last accessed: May 13, 2015]
5 Khanna D, et al. Safety and efficacy of subcutaneous
tocilizumab in adults with systemic sclerosis: week 48 data from
the faSScinate trial. Oral presentation at EULAR, 2015. Abstract
number: OP0054. Presentation date: Thursday, June 11, 2015.
Presentation time: 10:35pm.
6 Clements PJ, et al. Skin thickness score as a predictor and
correlate of outcome in systemic sclerosis. Arth and Rheum. 2000;
43(11): 2445-2454.
7 Steen VD, Medsger Jr TA. Improvement in skin thickening in
systemic sclerosis associated with improved survival. Arth and
Rheum. 2001; 44(12): 2828-2835.
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version on businesswire.com: http://www.businesswire.com/news/home/20150610005206/en/
GenentechMedia Contact:Allison Neves, (650) 467-6800Investor
Contact:Stefan Foser, (650) 467-2016
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