European Commission Approves Surgical Patch TachoSil® (human thrombin/human fibrogen) for Use in Neurological Surgery

Osaka, Japan, April 27, 2016 – Takeda Pharmaceutical Company Limited (Takeda) today announced that the European Commission has granted an expanded indication for surgical patch TachoSil (human thrombin/human fibrogen) for use in adults for supportive sealing of the dura mater to prevent postoperative cerebrospinal leakage following neurological surgery. Dura mater is the outermost and most fibrous of the three membranes covering the brain and spinal cord.

TachoSil received Marketing Authorization in the European Union in June 2004. With the new expanded indication, TachoSil becomes the first and only dual action surgical patch approved in adults for:
-          Improvement of hemostasis, or the arrest of bleeding;
-          Tissue sealing;
-          Suture support in vascular surgery; and
-          Supportive sealing to prevent postoperative cerebrospinal leakage following neurological surgery.

“With the expansion of TachoSil’s indication, Takeda will bring the potential benefits of this important product to surgical teams and those patients undergoing lung, neurological and other types of surgery requiring rapid and efficacious sealing of surgical wounds,” said Alexander Konstantinidis, Global Program Leader, Takeda.

The new indication was supported by clinical data from a randomized controlled study in 726 patients undergoing skull base surgery. The study demonstrated the benefit of TachoSil in preventing postoperative leakage of cerebrospinal fluid and related complications compared to standard surgical practice.

“The use of TachoSil for dura sealing may benefit appropriate patients following neurological surgery by reducing the risk of postoperative cerebrospinal fluid leak. This may potentially avoid associated serious complications, such as infection after surgery, trauma and swelling of the brain," said Vilhelm Tetens, Global Clinical Lead, TachoSil, Takeda.

About TachoSil
TachoSil is a ready-to-use surgical patch developed to assist surgeons in achieving fast and reliable bleeding control and tissue sealing. The product is indicated for supportive treatment in surgery for improvement of hemostasis and tissue sealing where standard techniques are insufficient (the exact label varies with country or region). TachoSil is available in more than 50 countries worldwide.

TachoSil is a clinically proven hemostat and tissue sealant based on clinical study data and postmarketing safety data from an estimated total of more than five million patients treated to date.

IMPORTANT SAFETY INFORMATION
TachoSil is not recommended for use in children below age 18 years due to insufficient data on safety and efficacy.

Contraindications
TachoSil must not be applied intravascularly. Hypersensitivity to the active substances or to any of the excipients.

Warnings and Precautions for Use

For epilesional use only.
Do not use intravascularly. Life threatening thromboembolic complications may occur if the preparation is applied intravascularly.
Specific data have not been obtained on the use of this product in gastrointestinal anastomoses surgery.
It is not known whether recent radiation therapy affects the efficacy of TachoSil when used for dura mater sealing.
As with any protein-containing product, allergic type hypersensitivity reactions are possible. Signs of hypersensitivity reactions include hives, generalized urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis. If these symptoms occur, the administration has to be discontinued immediately.
To prevent the development of tissue adhesions at undesired sites, ensure tissue areas outside the desired application area are adequately cleansed before administration of TachoSil. Events of adhesions to gastrointestinal tissues leading to gastrointestinal obstruction have been reported with use in abdominal surgery carried out in proximity to the bowel.
In case of shock, the current medical standards for shock treatment should be observed.
Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.
The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV and for the non-enveloped virus HAV. The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19. Parvovirus B19 infection may be serious for pregnant women (fetal infection) and for individuals with immunodeficiency or increased erythropoiesis (e.g. hemolytic anemia).
It is strongly recommended that every time TachoSil is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.

Undesirable Effects

Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the application site, bronchospasm, chills, flushing, generalized urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) may occur in rare cases in patients treated with fibrin sealants/hemostatics. In isolated cases, these reactions may progress to severe anaphylaxis. Such reactions may especially be seen, if the preparation is applied repeatedly, or administered to patients known to be hypersensitive to constituents of the product.
Antibodies against components of fibrin sealant/hemostatic products may occur rarely.
Thromboembolic complications may occur if the preparation is applied intravascularly.

Adverse Reactions
Adverse reactions include anaphylactic shock, hypersensitivity, thrombosis, intestinal obstruction (in abdominal surgeries) and adhesions.

Indication for TachoSil
TachoSil is indicated in adults for supportive treatment in surgery for improvement of hemostasis, to promote tissue sealing, for suture support in vascular surgery where standard techniques are insufficient, and for supportive sealing of the dura mater to prevent postoperative cerebrospinal leakage following neurological surgery.

Please consult with your local regulatory agency for approved labeling in your country.

Please see local prescribing information for TachoSil.

About Takeda Pharmaceutical Company Limited
Takeda Pharmaceutical Company Limited (TSE: 4502)is a global, R&D-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its research efforts on oncology, gastroenterology and central nervous system therapeutic areas. It also has specific development programs in specialty cardiovascular diseases as well as late-stage candidates for vaccines. Takeda conducts R&D both internally and with partners to stay at the leading edge of innovation. New innovative products, especially in oncology and gastroenterology, as well as its presence in emerging markets, fuel the growth of Takeda. More than 30,000 Takeda employees are committed to improving quality of life for patients, working with our partners in health care in more than 70 countries. For more information, visit http://www.takeda.com/news.

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Media Contact:

Elissa J. Johnsen
Takeda Pharmaceuticals
+1 (224) 554-3185
[email protected]

Tsuyoshi Tada
Takeda Pharmaceutical Company Ltd.
+81-3-3278-2417
tsuyoshi.tada@takeda.com