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|August 30, 2012 3:33 a.m.|
|Teva Announces FDA Grants Approval for Tbo-filgrastim for the Treatment of Chemotherapy-Induced Neutropenia|
First New Treatment for Neutropenia Approved in
Teva currently markets filgrastim in
"As a company dedicated to bringing needed medicines to patients, we are delighted with the approval of tbo-filgrastim which offers physicians and their patients undergoing chemotherapy a new supportive care treatment option," said Dr.
In studies of tbo-filgrastim, the drug was shown to have statistically significant reductions in the duration of severe neutropenia compared to placebo. During the first 21-day chemotherapy cycle, patients treated with tbo-filgrastim had severe neutropenia for an average of 1.1 days, compared with 3.8 days for those receiving placebo.
Neutropenia is a granulocyte disorder characterized by an abnormally low number of neutrophils. Neutrophils typically make up the majority of white blood cells and serve as the primary defense against infections by destroying bacteria in the blood. Patients with neutropenia are more susceptible to infections that, without medical attention, may become life-threatening. Chemotherapy can damage the body's ability to produce neutrophils, thereby causing neutropenia, which makes patients prone to infection and sepsis.
Granulocyte colony-stimulating factor (G-CSF) is a naturally occurring hormone that is produced by the body to stimulate the bone marrow to produce neutrophils, a type of white blood cell that helps the immune system fight infection. A recombinant form of G-CSF (known as a biologic) is used to treat cancer patients with neutropenia in order to stimulate the bone marrow to produce more white blood cells.
Tbo-filgrastim is a short-acting recombinant form of G-CSF which was designed to stimulate the bone marrow to produce white bloods cells to reduce the duration of severe neutropenia in patients receiving chemotherapy associated with a clinically significant incidence of febrile neutropenia (neutropenia with fever). Tbo-filgrastim is a solution for subcutaneous injection and will be supplied as a single use, preservative-free, prefilled syringe in doses of 300mcg/0.5mL and 480 mcg/0.8mL.
Important Safety Information
What are the possible side effects of tbo-filgrastim?
The most common side effect of tbo-filgrastim is bone pain. If this happens, it can usually be relieved with a non-aspirin pain reliever such as acetaminophen; or an NSAID such as ibuprofen.
Tell your doctor about any side effect that bothers you or that does not go away.
These are not all the possible side effects of tbo-filgrastim. For a complete list, ask your doctor or pharmacist.
You are encouraged to report negative side effects of prescription drugs to the
Visit http://www.fda.gov/medwatch, or call 1-800-
Teva's Safe Harbor Statement under the
This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on management's current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause our future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements, including statements relating to the results of the GALA phase III trial and the potential efficacy or future market or marketability of glatiramer acetate 40 mg/1 ml. Following further analysis, Teva's interpretation of the results could differ materially depending on a number of factors, and we caution investors not to place undue reliance on the forward-looking statements contained in this press release as there can be no guarantee that the results from the phase III trial discussed in this press release will be confirmed upon full analysis of the results of the trial and additional information relating to the safety, efficacy or tolerability of glatiramer acetate 40 mg/1 ml may be discovered upon further analysis of data from the phase III trial. Even if the results described in this release are confirmed upon full analysis of the GALA study, we cannot guarantee that glatiramer acetate 40 mg/1 ml will be approved for marketing in a timely manner, if at all, by regulatory authorities in the EU or in the U.S. Important factors that could cause or contribute to such differences include risks relating to: our ability to develop and commercialize additional pharmaceutical products, competition for our innovative products, especially Copaxone® (including competition from innovative orally-administered alternatives, as well as from potential generic equivalents), competition for our generic products (including from other pharmaceutical companies and as a result of increased governmental pricing pressures), competition for our specialty pharmaceutical businesses, our ability to achieve expected results through our innovative R&D efforts, the effectiveness of our patents and other protections for innovative products, decreasing opportunities to obtain U.S. market exclusivity for significant new generic products, our ability to identify, consummate and successfully integrate acquisitions (including the acquisition of Cephalon), the effects of increased leverage as a result of the acquisition of Cephalon, the extent to which any manufacturing or quality control problems damage our reputation for high quality production and require costly remediation, our potential exposure to product liability claims to the extent not covered by insurance, increased government scrutiny in both the U.S. and
Teva Pharmaceutical Industries Ltd.