Teva Receives Positive Outcome for COPAXONE® 40 mg/ml 3 Times Weekly Label in Europe
Doctors now have another treatment option – if needed – to discuss
with women with relapsing forms of multiple sclerosis who are trying for
a family, or are pregnant
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.
About COPAXONE®
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®.
About Teva
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.
INTENDED FOR EU BASED HEALTH TRADE, PROFESSIONAL & SPECIALIST
HEALTHCARE MEDIA
Contacts
Teva Pharmaceutical Industries Ltd.
PR:
Israel
Iris
Beck Codner, 972 (3) 926-7687
or
United States
Denise
Bradley, 215-591-8974
or
United States
Nancy
Leone, 215-284-0213
