AMSTERDAM--(BUSINESS WIRE)--Teva Pharmaceutical Industries Ltd. today announced that it has received a positive outcome through the variation procedure to remove the pregnancy contraindication from the European label for (glatiramer acetate injection) COPAXONE® 40 mg/ml 3 times weekly. The product was originally authorized through a decentralized procedure in Europe. An equivalent change has already been approved for COPAXONE® 20 mg/ml in December 2016.
According to the European Multiple Sclerosis Platform (EMSP) around 700,000 people in Europe are affected by Multiple Sclerosis (MS), with a 2:1 ratio between women and men. MS is more common among women of childbearing age compared with any other age group with the average age of diagnosis approximately 30 years, with ~43% of the women starting a family after diagnosis.
The removal of the pregnancy contraindication follows a Positive Variation Assessment Report issued by the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA; Reference Member State), and agreed by all Concerned Member States (CMS) in Europe, that were involved in the procedure. Granting of national approvals by all involved EU Member States will happen in the near future. COPAXONE® is indicated for the treatment of patients with relapsing forms of multiple sclerosis (RMS).
The variation approval was granted based on an analysis of prospective pregnancy cases with known outcome and confirmed exposure to COPAXONE® 40 mg/ ml 3 times weekly, from Teva's Glatiramer Acetate (GA) Pharmacovigilance Database. This further strengthens the conclusion of the robust analysis of COPAXONE® 20 mg/ml pregnancy data, based on more than 2,000 pregnancy cases. To date, this is the largest analyzed dataset of pregnant women with MS who were exposed to disease modifying therapies (DMTs) during pregnancy.
The Label Now Reads: Studies in animals have not shown reproductive toxicity (see section 5.3). Current data on the use of Copaxone 20 mg/ml in pregnant women indicate no malformative or feto/neonatal toxicity. Data on the use of Copaxone 40 mg/ml are consistent with these findings. To date, no relevant epidemiological data are available. As a precautionary measure, it is preferable to avoid the use of Copaxone during pregnancy unless the benefit to the mother outweighs the risk to the foetus.
“At Teva, we are committed to helping women with RMS lead the complete lives they desire,” said Rob Koremans MD, President and CEO, Teva Global Specialty Medicines. “While it is still preferable not to use any MS treatments during pregnancy, it is now possible for women to consult with their doctor and consider taking COPAXONE® during pregnancy if appropriate and depending on their individual circumstances. For those women who can’t stop taking the medication, who were previously discouraged from having children, the removal is excellent news and further underlines the established safety, efficacy and tolerability profile of COPAXONE®.”
About Pregnancy and Multiple Sclerosis
Multiple sclerosis (MS) is more prevalent among women of childbearing age compared with any other age group. MS treatments are generally discontinued when a woman is trying to conceive, or in the case of an unintended pregnancy, once the pregnancy is confirmed. However, for pregnant women with severe or highly active MS, the benefit of treatment may outweigh the unknown risk to the fetus, and this is a decision to be made by the treating physician.
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. The COPAXONE® brand is approved in more than 50 countries worldwide, including the United States, Russia, Canada, Mexico, Australia, Israel, and all European 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®.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) is a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions used by approximately 200 million patients in 100 markets every day. Headquartered in Israel, Teva is the world’s largest generic medicines producer, leveraging its portfolio of more than 1,800 molecules to produce a wide range of generic products in nearly every therapeutic area. In specialty medicines, Teva has the world-leading innovative treatment for multiple sclerosis as well as late-stage development programs for other disorders of the central nervous system, including movement disorders, migraine, pain and neurodegenerative conditions, as well as a broad portfolio of respiratory products. Teva is leveraging its generics and specialty capabilities in order to seek new ways of addressing unmet patient needs by combining drug development with devices, services and technologies. Teva's net revenues in 2016 were $21.9 billion. For more information, visit www.tevapharm.com.
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