|View printer-friendly version|
|October 03, 2013 10:12 a.m.|
|Teva to Present Further Results of Twenty-Year Open-Label Extension Study of Glatiramer Acetate 20 mg Daily for Relapsing-Remitting Multiple Sclerosis|
“To our knowledge, glatiramer acetate is the only treatment for multiple
sclerosis that has been prospectively studied for nearly two decades in
a continuously monitored, long-term study,” said Dr.
In this analysis of 74 patients, the cumulative annualized relapse rate (ARR) over the study period was 0.2, with 24.3 percent of patients remaining relapse-free through the entire observation period. Additionally, 63.3 percent of enrolled patients stayed below EDSS 4, while 79.5 percent stayed below EDSS 6 throughout the course of the study. Advancement to secondary progressive MS (SPMS), defined by a greater than 1.0-point EDSS progression (or greater than 0.5 for patients with baseline scores greater than 6) sustained for greater than or equal to 12 months without relapse, was seen in 35 patients (47 percent). Adverse events (AEs) leading to study discontinuation with incidence greater than one percent over the 20-year observation period were largely related to site reactions, while incidence of serious AEs were notably low, with no unexpected findings.
ABOUT THE OPEN-LABEL EXTENSION STUDY
The open-label extension study is a long-term clinical analysis of patients that participated in the original 36-month, randomized placebo-controlled U.S. Glatiramer Acetate Trial. The objective of the extension study was to evaluate the long-term neurologic disease course, and the safety and efficacy of glatiramer acetate 20 mg daily, in patients with relapsing-remitting multiple sclerosis. Ongoing patients in this study were continuously treated with glatiramer acetate 20 mg daily for a mean of 19.3 years (SD=1.3, range 18-21) with an average disease duration of 27.3 years. Baseline assessments for each patient in this pooled analysis were taken at the start of GA therapy.
COPAXONE® (glatiramer acetate injection) is indicated for the
reduction of the frequency of relapses in relapsing-remitting multiple
sclerosis, including patients who have experienced a first clinical
episode and have MRI features consistent with multiple sclerosis. The
most common side effects of COPAXONE® are redness, pain,
swelling, itching, or a lump at the site of injection, flushing, rash,
shortness of breath, and chest pain. See additional important
information at: http://www.sharedsolutions.com/redirect/PrescribingInformation.pdf.
For hardcopy releases, please see enclosed full prescribing information.
COPAXONE® is now approved in more than 50 countries
Important Safety Information about COPAXONE®
Patients allergic to glatiramer acetate or mannitol should not take COPAXONE®. Some patients report a short-term reaction right after injecting COPAXONE®. This reaction can involve flushing (feeling of warmth and/or redness), chest tightness or pain with heart palpitations, anxiety, and trouble breathing. These symptoms generally appear within minutes of an injection, last about 15 minutes, and go away by themselves without further problems. During the postmarketing period, there have been reports of patients with similar symptoms who received emergency medical care. If symptoms become severe, patients should call the emergency phone number in their area. Patients should call their doctor right away if they develop hives, skin rash with irritation, dizziness, sweating, chest pain, trouble breathing, or severe pain at the injection site. If any of the above occurs, patients should not give themselves any more injections until their doctor tells them to begin again. Chest pain may occur either as part of the immediate postinjection reaction or on its own. This pain should only last a few minutes. Patients may experience more than one such episode, usually beginning at least one month after starting treatment. Patients should tell their doctor if they experience chest pain that lasts for a long time or feels very intense. A permanent indentation under the skin (lipoatrophy or, rarely, necrosis) at the injection site may occur, due to local destruction of fat tissue. Patients should follow proper injection technique and inform their doctor of any skin changes. The most common side effects of COPAXONE® are redness, pain, swelling, itching, or a lump at the site of injection, flushing, rash, shortness of breath, and chest pain. These are not all of the possible side effects of COPAXONE®. For a complete list, patients should ask their doctor or pharmacist. Patients should tell their doctor about any side effects they have while taking COPAXONE®.
Patients are encouraged to report negative side effects of prescription
drugs to the
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. 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 purported 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, the effects of increased leverage as a result of
recent acquisitions, 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