"We commend the
Medicines may qualify for Fast Track designation if they are intended to treat a serious or life-threatening disease or condition and demonstrate the potential to address unmet medical needs. Fast Track designation provides greater access to and more frequent communication with the
The Company submitted the Investigational New Drug (IND) application for ACTIMMUNE in the treatment of FA in
About Friedreich's ataxia (FA)
FA is a debilitating, life-shortening and degenerative neuro-muscular disorder that affects about one in 50,000 people in
ACTIMMUNE (interferon gamma-1b) is a biologically manufactured protein similar to one the body makes naturally to help prevent infection. ACTIMMUNE is currently approved by the
IMPORTANT SAFETY INFORMATION
APPROVED USES FOR ACTIMMUNE (interferon gamma 1-b)
Chronic Granulomatous Disease (CGD)
ACTIMMUNE is indicated to reduce the frequency and severity of serious infections associated with Chronic Granulomatous Disease. CGD is a genetic disorder that affects the functioning of some cells of the immune system.
Severe, Malignant Osteopetrosis (SMO)
ACTIMMUNE is indicated to slow the worsening of severe, malignant osteopetrosis. SMO is a genetic disorder that affects normal bone formation.
IMPORTANT SAFETY INFORMATION (ISI)
The most common side effects with ACTIMMUNE are "flu-like" symptoms such as fever, headache, chills, myalgia (muscle pain) or fatigue, which may decrease in severity as treatment continues. Bedtime administration of ACTIMMUNE may minimize some of these symptoms. Acetaminophen may be helpful in preventing fever and headache.
If you are pregnant or plan to become pregnant or plan to nurse you should consult your physician.
ACTIMMUNE can cause severe allergic reactions and/or rash. Do not use ACTIMMUNE if you are allergic to interferon-gamma, E. coli-derived products or any component of the product (See Full Prescribing Information for a list of components). If you develop a serious reaction to ACTIMMUNE, discontinue it immediately and contact your doctor or seek medical help.
At high doses, ACTIMMUNE can cause (flu-like) symptoms, which may worsen some pre-existing heart conditions. Tell your doctor if you have a cardiac condition, such as irregular heartbeat, heart failure or decreased blood flow to your heart.
ACTIMMUNE may cause reversible changes to your nervous system, including decreased mental status, walking disturbances and dizziness. Tell your doctor if you have a history of seizures or other neurologic disorders.
Bone marrow function may be suppressed with ACTIMMUNE and decreased production of cells important to the body may occur. This effect, which can be severe, is usually reversible when the drug is discontinued or the dose is reduced. Tell your doctor if you have, or have had, reduced bone marrow function. Your doctor will monitor these cells with blood tests at the beginning of therapy and at 3 month intervals thereafter.
Taking ACTIMMUNE may cause reversible changes to your liver function, particularly in patients less than one year old. Your doctor will monitor your liver function with blood tests at the beginning of therapy and at 3 month intervals. If the patient is 1 year or less, monitoring will be done on a monthly basis.
If you are receiving ACTIMMUNE at home, your doctor will provide to you or your caregiver appropriate instructions on the administration of the drug and disposal of the container, needles and syringes.
You are encouraged to report negative side effects of prescription drugs to the
This information is not intended to replace discussions with your doctor. For additional information about ACTIMMUNE, please consult the Full Prescribing Information and the Information for the Patient/Caregiver and talk to your doctor. ACTIMMUNE is available by prescription only.
Visit www.ACTIMMUNE.com to download a copy of the ACTIMMUNE Full Prescribing Information.
This press release contains forward-looking statements, including statements regarding potential clinical trials evaluating ACTIMMUNE in Friedreich's ataxia patients, the potential benefits of Fast Track designation, and Horizon's plans to conduct clinical development of ACTIMMUNE in Friedreich's ataxia. Forward-looking statements speak only as of the date of this press release and Horizon does not undertake any obligation to update or revise these statements, except as may be required by law. These forward-looking statements are based on management's expectations and assumptions as of the date of this press release and actual results may differ materially from those in these forward-looking statements as a result of various factors. These factors include, but are not limited to, risks regarding whether results of subsequent studies will be consistent with results of prior studies, whether Horizon will conduct further studies of ACTIMMUNE or have the financial resources to do so, whether Horizon realizes any of the potential benefits of Fast Track designation, and the risks associated with pre-clinical and clinical development of drug candidates. For a further description of these and other risks facing Horizon, please see the risk factors described in Horizon's filings with the
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