Tuesday, Dec 10, 2019

FDA Accepts Supplemental Biologics License Application for Xolair (Omalizumab) for the Treatment of Nasal Polyps

The submission is based on positive results from the Phase III POLYP 1 and POLYP 2 studies of Xolair in adults with chronic rhinosinusitis with nasal polyps with inadequate response to intranasal corticosteroids

If approved, Xolair would become the first antibody to help reduce the size of

nasal polyps and help improve symptoms through targeting and blocking immunoglobulin E

Frequently co-occurring with other respiratory conditions, nasal polyps is a chronic condition and causes a range of symptoms impacting patients’ lives including loss of sense of smell and nasal congestion

South San Francisco, CA -- December 10, 2019 --

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Xolair^® (omalizumab) for the treatment of nasal polyps in adult patients 18 years of age and older with inadequate response to intranasal corticosteroids. If approved, Xolair would become the first antibody to help reduce the size of nasal polyps and help improve symptoms through targeting and blocking immunoglobulin E (IgE). The FDA is expected to make a decision on approval for this indication by Q3 2020.

“Nasal polyps may limit patients’ ability to breathe and smell normally and causes other symptoms that can negatively impact their lives. There is a critical need for new treatment options for the millions of people living with this condition,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “Results from our two Phase III studies in nasal polyps add to our understanding of Xolair as a potential treatment option across allergic respiratory conditions and associated comorbidities.”

Nasal polyps is a common and potentially debilitating condition in adults, impacting 13 million people in the U.S. Currently, there are limited treatment options available and many patients opt for nasal surgery or systemic steroids, which often cannot effectively control symptoms over time due to nasal polyps regrowth. Nasal polyps presents as noncancerous lesions on the lining of the nasal sinuses or nasal cavity associated with irritation and inflammation, which can block normal airflow. Frequently co-occurring with other respiratory conditions, nasal polyps impacts approximately 45% of people with adult-onset asthma and approximately 30% of people with chronic rhinosinusitis, resulting in chronic rhinosinusitis with nasal polyps (CRSwNP) if the nasal polyps and sinusitis symptoms are present for 12 weeks or longer. After sinus surgery, nasal polyps recurs in up to 80% of people, with approximately 40% requiring at least one further surgery.

This sBLA is based on results from the Phase III POLYP 1 and POLYP 2 trials, which showed Xolair met both co-primary and multiple secondary endpoints in treating adult patients with CRSwNP who have not adequately responded to intranasal corticosteroids. The co-primary endpoints were change from baseline in Nasal Polyp Score (NPS) and change from baseline in average daily Nasal Congestion Score (NCS) at 24 weeks. Key secondary endpoints that were met included improvement in the Sino-Nasal Outcome Test-22 (SNOT-22) health-related quality of life assessment, improvement in sense of smell, post-nasal drip (posterior rhinorrhea), and runny nose (anterior rhinorrhea). The safety profile in these trials were consistent with the known safety profile for Xolair, with no new unexpected safety signals identified. Full results from the POLYP 1 and POLYP 2 studies were recently presented during an oral session at the 2019 American College of Allergy, Asthma and Immunology (ACAAI) Annual Meeting (abstract #D450).

Xolair is an injectable biologic medicine designed to target and block IgE. Xolair is currently approved for the treatment of moderate to severe persistent allergic asthma in people six years of age or older whose asthma symptoms are not controlled by inhaled corticosteroids, and for chronic idiopathic urticaria (CIU) in people 12 years of age and older who continue to have hives that are not controlled by H1 antihistamines. In the U.S., Genentech and Novartis Pharmaceuticals Corporation work together to develop and co-promote Xolair.

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 intranasal corticosteroids. Both trials were randomized, multicenter, double-blind and placebo-controlled. POLYP 1 included 138 patients and POLYP 2 included 127 patients. The co-primary outcomes for both trials were change from baseline to week 24 in average daily Nasal Congestion Score and Nasal Polyp Score. Patients in the studies were administered either Xolair or placebo by subcutaneous injection every two to four weeks in addition to background intranasal corticosteroid.

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.

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 breathing
• 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 trouble swallowing

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.

Receiving Xolair

• Xolair should be given by a healthcare provider in a healthcare setting.
• 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 Xolair treatment.

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 received Xolair.
• 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 provider.
• 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 Xolair.

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.

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.

# # #