Sunday, Jun 2, 2019
South San Francisco, CA -- June 2, 2019 --
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.
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.
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.
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.
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