Phase III Results Showed omalizumab Significantly Reduced Disease Severity
in Patients with a Chronic Form of Hives who Failed Standard Therapy
Study Published in NEJM Today and Presented Tomorrow at AAAAI Annual Meeting
2013 AAAAI Annual Meeting
SOUTH SAN FRANCISCO, Calif. -- February 24, 2013
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today
announced results from a Phase III trial, ASTERIA II, which demonstrated that
omalizumab met its primary endpoint in patients with moderate to severe
chronic idiopathic urticaria (CIU), who remained symptomatic despite treatment
with approved H1 antihistamine doses^1. The data were published today in the
New England Journal of Medicine and will be presented tomorrow at the American
Academy of Allergy, Asthma and Immunology (AAAAI) Annual Meeting in San
CIU, also referred to as chronic spontaneous urticaria (CSU) outside the
United States, is a skin condition characterized by red, swollen, itchy hives
on the skin^2,3 and is diagnosed when hives spontaneously present and reoccur
for more than six weeks^2. Angioedema, or swelling of the deep layers of skin,
is common in patients with CIU^4,5. ^ At any given time, the prevalence of CIU
is approximately 0.5 percent to 1 percent worldwide^4,5. Currently, H1
antihistamines are the only approved therapy for patients suffering from CIU.
"We are pleased with the results of the ASTERIA II study, as people with
chronic idiopathic urticaria unresponsive to H1 antihistamines need new
treatment options,” said Hal Barron, M.D., chief medical officer and head of
Global Product Development. “We look forward to sharing the results of two
additional Phase III omalizumab CIU studies at upcoming medical meetings this
Genentech plans to file a supplemental biologics license application (sBLA)
with the U.S. Food and Drug Administration (FDA) for omalizumab in CIU later
this year. The ASTERIA II data are the first Phase III results to be presented
from the omalizumab clinical trial program in CIU, which also includes two
additional Phase III studies (GLACIAL and ASTERIA I) investigating the
efficacy and safety profile of omalizumab over 24-week treatment duration.
The primary endpoint was measured using a 21-point scale known as a weekly
Itch Severity Score (ISS)^1. Patients used an electronic diary to report their
daily itch severity (0=none, 1=mild, 2=moderate, and 3=severe), with potential
weekly scores ranging from 0–21^1. Three dose groups were chosen and compared
to a placebo group. The study met its primary endpoint in two of the three
dose groups studied, showing that omalizumab administered every four weeks led
to significant improvement in the mean weekly ISS from baseline (approximately
14 in all treatment groups) at Week 12.
The improvements were 8.1 to 9.8 in two of the dose groups, respectively
compared to a 5.1 improvement in patients on placebo. One of the dose groups
studied did not demonstrate statistical significance compared to placebo for
the primary endpoint. The incidence and severity of adverse events (AEs) was
similar across treatment groups^1.
All eight pre-specified secondary endpoints in the ASTERIA II trial were met
for the two dose groups that met the primary endpoint, except for one dose
group that did not show a significant difference from placebo in the
proportion of angioedema-free days from Week 4 to Week 12 of therapy^1. ^
Patient response, as measured by the median time to Minimally Important
Difference (MID) in itch severity score, a secondary endpoint, occurred at
week one with omalizumab compared with four weeks in the placebo group^1.
Nine patients experienced serious adverse events (SAEs): two patients in the
placebo group reported SAEs of pneumonia and hemorrhoids; in the three
omalizumab dose groups, seven patients reported SAEs of angioedema (two),
urticaria, idiopathic urticaria (two), melanoma in situ (onset stage of skin
cancer), nephrolithiasis (kidney stones), tonsillectomy, and melena (black
blood in stool). No SAEs were suspected to be caused by the study drug or led
to withdrawal from treatment^1. No deaths were reported during the study^1.
About ASTERIA II
ASTERIA II was a Phase III, global, multicenter, randomized, double-blind,
placebo-controlled study evaluating the efficacy and safety profile of
omalizumab compared with placebo in 323 patients 12 to 75 years of age with
moderate to severe CIU who were receiving H1 antihistamine therapy at approved
doses. Patients were randomized to three omalizumab dose groups or placebo,
given every four weeks, for a total of three doses within a 12-week treatment
In addition to the primary endpoint, the study had eight pre-specified
secondary endpoints: Change from baseline in weekly urticaria activity score
(UAS7) at Week 12; Change from baseline in weekly number of hives score at
Week 12; Time to MID (MID=5) response in weekly itch severity score by Week
12; Proportion of patients with UAS7 ≤ 6 at Week 12; Change from baseline in
overall dermatology life quality index (DLQI) at Week 12; Proportion of
angioedema-free days from Week 4 to Week 12; Proportion of patients with MID
response in weekly itch at Week 12; Change from baseline in size of largest
hives score at Week 12.
Omalizumab is jointly developed by Genentech under an agreement with Novartis
Pharma AG and is co-marketed in the United States with Novartis
XOLAIR is not indicated for Chronic Idiopathic Urticaria.
XOLAIR^® (omalizumab) for subcutaneous use is an injectable, prescription
medicine for patients 12 years of age and older. It is for patients with
moderate to severe persistent allergic asthma caused by year-round allergens
in the air. A skin or blood test is done to see if you have allergic asthma.
XOLAIR is for patients who are not controlled by asthma medicines called
XOLAIR helps reduce the number of asthma attacks in people with allergic
asthma who still have asthma symptoms even though they are taking inhaled
Important Limitations of Use
*XOLAIR has not been proven to work in other allergic conditions.
*XOLAIR is not a rescue medicine and should not be used to treat sudden
*XOLAIR should not be used in children under 12 years of age.
IMPORTANT SAFETY INFORMATION IN MODERATE TO SEVERE ALLERGIC ASTHMA
XOLAIR should always be injected in a doctor’s office. Patients should read
the Medication Guide before starting XOLAIR treatment and before each and
A severe allergic reaction called anaphylaxis has happened in some patients
after they received XOLAIR. Anaphylaxis is a life-threatening condition and
can lead to death. Patients must seek emergency medical treatment right away
if symptoms occur.
Signs and symptoms of anaphylaxis include:
*wheezing, shortness of breath, cough, chest tightness, or trouble
*low blood pressure, dizziness, fainting, rapid or weak heartbeat, anxiety,
or feeling of "impending doom"
*flushing, itching, hives, or feeling warm
*swelling of the throat or tongue, throat tightness, hoarse voice, or
Anaphylaxis from XOLAIR can happen:
*right after receiving a XOLAIR injection or hours later
*after any XOLAIR injection. Anaphylaxis has occurred after the first
XOLAIR injection or after many XOLAIR injections.
A patient’s healthcare provider should watch the patient for some time in the
office for signs or symptoms of anaphylaxis after injecting XOLAIR. If
patients have signs or symptoms of anaphylaxis, they must tell their
healthcare provider right away.
Patients must not receive XOLAIR if they have ever had an allergic reaction to
a XOLAIR injection. Patients should not use XOLAIR if they are allergic to any
of its ingredients.
In clinical studies, a variety of cancer types, including breast, skin,
prostate, and parotid (a type of salivary gland), were reported in more
patients who received XOLAIR than in patients who did not receive XOLAIR.
XOLAIR is not a rescue medicine and should not be used to treat sudden asthma
XOLAIR is not a substitute for the medicines patients are already taking.
Patients must not change or stop taking any of their other asthma medicines
unless their doctor tells them to do so.
Some patients on XOLAIR may have an abnormal increase in eosinophils (a type
of white blood cell) in the blood or tissues, sometimes causing an
inflammation of blood vessels, which can lead to rash, worsening of
respiratory symptoms, heart trouble, and/or nerve pain and weakness.
Joint inflammation or pain, rash, fever, and swollen lymph nodes have been
seen in some patients taking XOLAIR after the first or subsequent injections.
Patients should talk to their doctor if they have experienced any of these
signs and symptoms.
The most commonly seen side effects occurring more frequently in patients
receiving XOLAIR than in patients who received placebo (an injection with no
active medicine) were joint pain, pain (general), leg pain, tiredness
(fatigue), dizziness, fracture, arm pain, itching, inflammation of the skin,
In asthma studies, the most common side effects in patients, who either needed
to stop XOLAIR or needed medical attention, were injection site reaction,
viral infections, upper respiratory tract infection, sinusitis, headache, and
sore throat. These side effects were seen at similar rates in XOLAIR-treated
patients as in patients that did not receive XOLAIR.
There are other possible side effects with XOLAIR. Patients should talk to
their doctor for more information and if they have any questions about their
XOLAIR has not been studied in pregnant women. Pregnant women exposed to
XOLAIR are encouraged to enroll in the XOLAIR Pregnancy Exposure Registry.
Patients can get more information by calling 1-866-4XOLAIR (1-866-496-5247) or
by speaking with their doctor.
Please visit http://www.xolair.com for the full Prescribing Information,
including Boxed WARNINGS and Medication Guide for additional important safety
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1 Maurer M, Rosén K, Hsieh HJ, et al. Omalizumab for the treatment of chronic
idiopathic or spontaneous urticaria. NEJM 2013; DOI: 10.1056/NEJMoa1215372
2 Asthma and Allergy Foundation of America (AAFA) website. “Chronic Urticaria
(Hives).” http://www.aafa.org/display.cfm?id=9&sub=23&cont=328. Accessed
November 14, 2012.
3 American Academy of Allergy Asthma & Immunology (AAAAI) website. “Skin
Accessed November 14, 2012.
4 Maurer M, Weller K, Bindslev-Jensen C, et al. Unmet clinical needs in
chronic spontaneous urticaria. A GA2LEN task force report. Allergy 2011; 66:
5 Bernstein J, Moellman J. Emerging concepts in the diagnosis and treatment of
patients with undifferentiated angioedema. Int J Emerg Med 2012. 5: 39.
Chris Vancheri, 650-467-6800
Thomas Kudsk Larsen, 650-467-2016
Karl Mahler, 011 41 61 687 8503
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