– The Phase III POLYP 1 and POLYP 2 studies of Xolair in adults with
chronic rhinosinusitis with nasal polyps (CRSwNP) with inadequate
response to intranasal corticosteroids met both co-primary endpoints and
key secondary endpoints –
– In both studies, Xolair showed a safety profile consistent with
previous FDA-approved indications –
– CRSwNP impacts up to 4 percent of people worldwide, and the
prevalence increases with age –
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY),
today announced positive topline data from two Phase III multicenter
studies evaluating Xolair® (omalizumab) for the treatment of
adults with chronic rhinosinusitis with nasal polyps (CRSwNP) who have
not adequately responded to intranasal corticosteroids. The POLYP 1 and
POLYP 2 Phase III trials met both co-primary endpoints and key secondary
endpoints. Xolair, an injectable biologic medicine designed to target
and block immunoglobulin E (IgE), was shown to be well tolerated and the
safety profile was consistent with that observed in previous studies in
people with moderate to severe allergic asthma and chronic idiopathic
“The results from these pivotal studies provided further support that
IgE plays a role in inflammatory and respiratory conditions, and showed
that Xolair reduced the size of nasal polyps and associated symptoms
that impact these patients’ quality of life,” said Sandra Horning, M.D.,
chief medical officer and head of Global Product Development. “We plan
to discuss these results with the FDA with the goal of bringing this new
treatment option as soon as possible to people who do not experience
relief with the current standard of care.”
The co-primary endpoints of POLYP 1 and POLYP 2 were change from
baseline in Nasal Polyp Score (NPS) and change from baseline in average
daily Nasal Congestion Score (NCS) over 24 weeks. Xolair demonstrated
statistically significant and clinically relevant improvements in both
of these co-primary outcomes. Patients enrolled in the study included
those with and without a history of surgery.
Key secondary endpoints were met, including improvement in smell,
post-nasal drip (posterior rhinorrhea score), runny nose (anterior
rhinorrhea score) and the Sino-Nasal Outcome Test-22 (SNOT-22)
health-related quality of life assessment.
CRSwNP is the inflammation of the nose and paranasal sinuses with the
presence of nasal polyps on the lining of the nasal sinuses or nasal
Additional findings from these trials will be presented at an upcoming
About POLYP 1 and POLYP 2
POLYP 1 and POLYP 2 are replicate Phase III studies designed to
determine the efficacy and safety of Xolair compared with placebo in
adult patients with CRSwNP who have had an inadequate response to
standard of care treatment. Both trials were randomized, multicenter,
double-blind and placebo-controlled. POLYP 1 involved 138 patients, and
POLYP 2 involved 127 patients. The primary outcomes for both trials were
change from baseline in average daily Nasal Congestion Score at week 24,
and change from baseline in Nasal Polyp Score to week 24. Patients in
the studies were administered either Xolair or placebo by subcutaneous
injection every two to four weeks.
About Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
Chronic rhinosinusitis with nasal polyps (CRSwNP) is the inflammation of
the nose and paranasal sinuses with the presence of noncancerous lesions
(nasal polyps) on the lining of the nasal sinuses or nasal cavity. It is
possible to have a single polyp or several and the size of the polyps
can vary from microscopic to several centimeters. Symptoms can include
nasal blockage/obstruction, nasal congestion, nasal discharge, facial
pain/pressure and reduction in or loss of smell. CRSwNP is diagnosed by
physical examination with endoscopy. The condition is associated with
asthma and aspirin sensitivity.
Xolair is the only approved antibody designed to target and block
immunoglobulin E (IgE). By reducing free IgE, down-regulating
high-affinity IgE receptors and limiting mast cell degranulation, Xolair
minimizes the release of mediators throughout the allergic inflammatory
In the U.S., Genentech and Novartis Pharmaceuticals Corporation work
together to develop and co-promote Xolair. Genentech is a leading
biotechnology company that discovers, develops, manufacturers and
commercializes medicines to treat patients with serious or
life-threatening medical conditions. Novartis Pharmaceuticals
Corporation is an affiliate of Novartis which provides innovative
healthcare solutions that address the evolving needs of patients and
Xolair U.S. Indication
Xolair for subcutaneous use is an injectable prescription medicine
approved by the FDA to treat:
Moderate to severe persistent asthma in patients six years of age or
older whose asthma symptoms are not controlled by asthma medicines
called inhaled corticosteroids. A skin or blood test is performed to
see if a patient has allergies to year-round allergens.
Chronic idiopathic urticaria (CIU; chronic hives without a known
cause) in patients 12 years of age and older who continue to have
hives that are not controlled by H1 antihistamine treatment.
Xolair is not used to treat other allergic conditions, other forms of
urticaria, acute bronchospasm or status asthmaticus.
Important Safety Information
The most important information patients should know about Xolair is
that a severe allergic reaction called anaphylaxis can happen when a
patient receives Xolair. The reaction can occur after the first dose, or
after many doses. It may also occur right after a Xolair injection or
days later. Anaphylaxis is a life-threatening condition and can lead to
death. Patients must go to the nearest emergency room right away if they
have any of these symptoms of an allergic reaction:
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
The patient’s healthcare provider will monitor the patient closely for
symptoms of an allergic reaction while they are receiving Xolair and for
a period of time after the patient’s injection. The patient’s healthcare
provider should talk to the patient about getting medical treatment if
they have symptoms of an allergic reaction after leaving the healthcare
provider’s office or treatment center.
Patients must not receive Xolair if they are allergic to
omalizumab or any of the ingredients.
Before receiving Xolair, patients must tell their healthcare provider
about all of their medical conditions, including if they:
have a latex allergy or any other allergies (such as food allergy or
seasonal allergies). The needle cap on the Xolair prefilled syringe
may contain latex.
- have sudden breathing problems (bronchospasm)
- have ever had a severe allergic reaction called anaphylaxis
- have or have had a parasitic infection
- have or have had cancer
are pregnant or plan to become pregnant. It is not known if Xolair may
harm a patient’s unborn baby.
are breastfeeding or plan to breastfeed. It is not known if Xolair
passes into breast milk. Talk with your healthcare provider about the
best way to feed your baby while you receive Xolair.
Patients must tell their healthcare provider about all the medicines
they take, including prescription and over-the-counter medicines,
vitamins, or herbal supplements.
Xolair should be given by a healthcare provider in a healthcare
Xolair is given in 1 or more injections under the skin
(subcutaneous), 1 time every 2 or 4 weeks.
In asthma patients, a blood test for a substance called IgE must be
performed prior to starting Xolair to determine the appropriate dose
and dosing frequency.
In patients with chronic hives, a blood test is not necessary to
determine the dose or dosing frequency.
Patients must not decrease or stop taking any of their other asthma or
hive medicine unless their healthcare providers tell them to.
Patients may not see improvement in their symptoms right away after
Possible Side Effects of Xolair
Xolair may cause serious side effects, including:
See, “What is the most important information I should know about
Xolair” in the Xolair Medication Guide at http://www.xolair.com regarding
the risk of anaphylaxis.
Cancer. Cases of cancer were observed in some people who
Inflammation of your blood vessels. Rarely, this can happen in
people with asthma who receive Xolair. This usually, but not always,
happens in people who also take a steroid medicine by mouth that is
being stopped or the dose is being lowered. It is not known whether
this is caused by Xolair. Tell your healthcare provider right away if
you have rash; chest pain; shortness of breath; or a feeling of pins
and needles or numbness of your arms or legs.
Fever, muscle aches, and rash. Some people who take Xolair get
these symptoms 1 to 5 days after receiving a Xolair injection. If a
patient has any of these symptoms, they must tell their healthcare
Parasitic infection. Some people who are at a high risk for
parasite (worm) infections, get a parasite infection after receiving
Xolair. The patient’s healthcare provider can test the patient’s stool
to check if they have a parasite infection.
Heart and circulation problems. Some people who receive Xolair
have had chest pain, heart attack, blood clots in the lungs or legs,
or temporary symptoms of weakness on one side of the body, slurred
speech, or altered vision. It is not known whether these are caused by
The most common side effects of Xolair:
In adults and children 12 years of age and older with asthma: pain
especially in the arms and legs, dizziness, feeling tired, skin rash,
bone fractures and pain or discomfort of the ears.
In children 6 to less than 12 years of age with asthma: common
cold symptoms, headache, fever, sore throat, pain or discomfort of
your ear, abdominal pain, nausea, vomiting and nose bleeds.
In people with chronic idiopathic urticaria: nausea,
headaches, swelling of the inside of the nose, throat or sinuses,
cough, joint pain and upper respiratory tract infection.
These are not all the possible side effects of Xolair. Patients should
call their doctor for medical advice about side effects.
Report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch.
Report side effects to Genentech at (888) 835-2555 or Novartis
Pharmaceuticals Corporation at 888-669-6682.
Please see full Prescribing Information, including Medication Guide
at http://www.xolair.com for
additional Important Safety Information.
Founded more than 40 years ago, Genentech is a leading biotechnology
company that discovers, develops, manufactures and commercializes
medicines to treat patients with serious and 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.
Andrew Villani, (650) 467-6800
Jocelyn Ashford, (650) 866-7579
Loren Kalm, (650) 225-3217
Karl Mahler, 011
41 61 687 8503