FDA Approves Genentech’s Xolair (Omalizumab) Prefilled Syringe Formulation

– 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 –

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY),
announced today that the U.S. 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)
indications. The new Xolair PFS formulation is expected to be available
by the end of this year for the first time in the U.S. Xolair is
currently available in a 150 mg single-dose vial with lyophilized,
sterile powder for reconstitution.

“Xolair has long been an important treatment option for people with
allergic asthma and CIU,” said Sandra Horning, M.D., chief medical
officer and head of Global Product Development. “The prefilled syringe
formulation reflects our continued commitment to provide healthcare
professionals with choices to best support each patient’s unique needs.”

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 people six years of age or older whose asthma
symptoms are not controlled by inhaled corticosteroids, and for CIU in
people 12 years of age and older who continue to have hives that are not
controlled by H1 antihistamines. Over 330,000 people in the U.S. have
been treated with Xolair since its initial approval for people 12 years
and older with allergic asthma in 2003.

About allergic asthma and chronic idiopathic urticaria

Asthma is a serious and chronic lung disease affecting an estimated 26
million people in the U.S. It causes swelling and narrowing of the
airways, making breathing difficult. Allergic asthma, the most common
form of asthma, accounts for approximately 60 percent of asthma cases in

Chronic idiopathic urticaria (CIU) is a skin condition that can cause
hives and severe itch that can last many months and years. CIU is
characterized by hives that spontaneously occur without an identifiable
cause, and recur for six weeks or more. It is estimated that
approximately 1.5 million people in the U.S. have CIU.

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

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
    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
  • 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
  • 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
for additional Important Safety Information.

About Xolair Access Solutions

Patients experiencing financial hardship may be eligible to receive
coverage and reimbursement support for Xolair. Patient assistance and
informational resources are available through Xolair Access Solutions (http://www.xolair.com/allergic-asthma/xolair-access-solutions.html).

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.


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