|View printer-friendly version|
|September 11, 2014 9:29 a.m.|
|Teva Presents New Data Which Demonstrate Reduction of Injection-Related Adverse Events with the Less Frequent Dosing of Three-times-a-week COPAXONE® (glatiramer acetate injection) 40 mg Compared to Daily COPAXONE® 20 mg|
The primary endpoint of the GLACIER study, the adjusted mean annualized rate of injection-related adverse events (IRAEs), was achieved with a 50 percent reduction with the three-times-a-week COPAXONE® 40 mg dosing regimen versus the daily COPAXONE® 20 mg regimen. In a post-hoc analysis, a similar reduction in moderate/severe IRAEs was observed with the less frequent, three-times-a-week COPAXONE® 40 mg arm relative to the daily COPAXONE® 20 mg arm.
“We’re pleased these results provide supportive data that fewer
injections with three-times-a-week COPAXONE® 40 mg resulted
in half as many reported IRAEs compared to the number of IRAEs with the
COPAXONE® 20 mg once-daily dosing regimen,” said
In the GLACIER study, 209 patients who had received daily COPAXONE® 20 mg for an average of 6.7 years, from 30 U.S. sites were randomized to receive COPAXONE® 40 mg (n=108) or COPAXONE® 20 mg (n=101). Patients were then assessed in the open-label design at months 1, 2 and 4. IRAEs included all local injection-site reactions (ISRs) and symptoms related to immediate post-injection reactions (IPIR; e.g., flushing, palpitations, anxiety, dyspnea) and were determined through patient diaries. Patient reported ISRs were classified as mild, moderate or severe. One patient in the 40 mg COPAXONE® arm withdrew due to injection site necrosis. The overall safety was consistent with prior experience, and the study results will be submitted to a peer-reviewed publication.
“The less frequent IRAEs resulting from the reduction of dosing
frequency from daily to three-times-a-week is an additional
consideration for patients when making treatment decisions,” said Dr.
COPAXONE® (glatiramer acetate injection) is indicated for the
treatment of patients with relapsing forms of 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: www.CopaxonePrescribingInformation.com
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
Safe Harbor Statement under the U.S. Private Securities Litigation Reform Act of 1995:
This release contains forward-looking statements, which are based on
management’s current beliefs and expectations. Such statements 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 orally-administered alternatives, as well as
from potential generic versions); the possibility of material fines,
penalties and other sanctions and other adverse consequences arising out
of our ongoing FCPA investigations and related matters; our ability to
achieve expected results from the research and development efforts
invested in our pipeline of specialty and other products; our ability to
reduce operating expenses to the extent and during the timeframe
intended by our cost reduction program; our ability to successfully
pursue and consummate suitable acquisitions or licensing opportunities;
the extent to which any manufacturing or quality control problems damage
our reputation for quality production and require costly remediation;
our potential exposure to product liability claims that are not covered
by insurance; increased government scrutiny in both the U.S. and
Teva Pharmaceutical Industries Ltd.