Novartis announces FDA approval of Xolair® (omalizumab) prefilled syringe formulation
Sep 28, 2018
Xolair, the only biologic approved for both allergic asthma and chronic idiopathic urticaria indications, is now also approved in a prefilled syringe (PFS) formulation
More than 330,000 patients have been treated with Xolair in the last 15 years
The 75 mg/0.5 mL and 150 mg/1 mL single-dose prefilled syringes are expected to be available by the end of 2018
EAST HANOVER, N.J., September 28, 2018 – Novartis announced today that the US Food and Drug Administration (FDA) has approved 75 mg/0.5 mL and 150 mg/1 mL single-dose prefilled syringes (PFS) for Xolair® (omalizumab) as an additional formulation for both allergic asthma and chronic idiopathic urticaria (CIU) indications2. The new Xolair PFS formulation is expected to be available by the end of this year for the first time in the US. Xolair is currently available in a 150 mg single-dose vial with lyophilized, sterile powder for reconstitution.
“The approval of Xolair prefilled syringe is part of our continuing commitment to people with allergic asthma and CIU,” said Fabrice Chouraqui, US President of Novartis Pharmaceuticals Corporation. “We’re reimagining medicine with meaningful therapies and various delivery systems to meet the evolving needs of healthcare professionals and patients.”
The Xolair PFS eliminates the need for healthcare providers to procure Sterile Water for Injection (SWFI) and reconstitute Xolair before administering the medicine.
Xolair is approved for the treatment of moderate to severe persistent allergic asthma in patients six years of age or older whose asthma symptoms are not controlled by inhaled corticosteroids, and for CIU in patients 12 years of age and older who continue to have hives that are not controlled by H1 antihistamines2. Over 330,000 people in the US have been treated with Xolair since its initial approval for patients 12 years and older with allergic asthma in 20031.
About Allergic Asthma and Chronic Idiopathic Urticaria Asthma is a serious and chronic lung disease affecting an estimated 26 million people in the US3,4. It causes swelling and narrowing of the airways, making breathing difficult. Allergic asthma, the most common form of asthma, accounts for approximately 60% of asthma cases in adults5,6.
Chronic Idiopathic Urticaria (CIU) is a skin condition that can cause hives and severe itch that can last many months and years7. CIU is characterized by hives that spontaneously occur without an identifiable cause, and recur for six weeks or more8. It is estimated that approximately 1.5 million people in the US have CIU7,9.
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 US, Novartis Pharmaceuticals Corporation and Genentech work together to develop and co-promote Xolair. Novartis Pharmaceuticals Corporation is an affiliate of Novartis which provides innovative healthcare solutions that address the evolving needs of patients and societies. Genentech is a leading biotechnology company that discovers, develops, manufacturers and commercializes medicines to treat patients with serious or life-threatening medical conditions.
Xolair US 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.
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 is 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.
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About Novartis Located in East Hanover, NJ, Novartis Pharmaceuticals Corporation is an affiliate of Novartis which provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has leading positions globally in each of these areas. In 2017, the Group achieved net sales of USD 49.1 billion, while R&D throughout the Group amounted to approximately USD 9.0 billion. Novartis Group companies employ approximately 125,000 full-time-equivalent associates. Novartis products are sold in approximately 155 countries around the world. For more information, please visit http://www.novartis.com.