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Xolair (Omalizumab) Significantly Reduced Nasal Polyps and Congestion Symptoms in Adults with Chronic Rhinosinusitis with Nasal Polyps in Two Phase III Studies

– 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
urticaria.

“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
cavity.

Additional findings from these trials will be presented at an upcoming
scientific congress.

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.

About Xolair

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
cascade.

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
societies.

Xolair U.S. Indication

Xolair for subcutaneous use is an injectable prescription medicine
approved by the FDA to treat:

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:

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:

Patients must tell their healthcare provider about all the medicines
they take
, including prescription and over-the-counter medicines,
vitamins, or herbal supplements.

Receiving Xolair

Possible Side Effects of Xolair

Xolair may cause serious side effects, including:

The most common side effects of Xolair:

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.

About Genentech

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.

Contacts

Media Contact:
Andrew Villani, (650) 467-6800

Advocacy Contact:
Jocelyn Ashford, (650) 866-7579

Investor Contact:
Loren Kalm, (650) 225-3217
Karl Mahler, 011
41 61 687 8503

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