September 26, 2011
Press Release
Mitsubishi Tanabe Pharma CorporationApproval for Additional Indication of Generalized Myasthenia GravisVenoglobulin® IH 5% for Intravenous Injection,a Human Immunoglobulin Preparation Derived from Donated Plasma
Osaka, Japan, September 26, 2011---Mitsubishi Tanabe Pharma Corporation (President& CEO: Michihiro Tsuchiya) announced that its consolidated subsidiary, Benesis
Corporation (Osaka, President: Junichi Watanabe), obtained approval, as of September 26,
2011, of a partial change to the indications of Venoglobulin® IH 5% for intravenous injection,a liquid human immunoglobulin preparation for intravenous injection derived from donatedplasma for generalized myasthenia gravis (only in case of insufficient response to steroids orimmunosuppressants).
Myasthenia gravis is an autoimmune disease characterized by muscle weakness andfatigability. It occurs in two forms: the ocular type, which presents only ocular symptoms
such as blepharoptosis and double vision, and the generalized type, which develops not
only with such ocular symptoms, but also with systemic symptoms such as weakness inarms and legs, difficulty in swallowing, and shortness of breath.
Treatment of generalized myasthenia gravis is based on immunosuppressive therapy withsteroids or immunosuppressants. In case of a lack of satisfactory effect or rapid
exacerbation of symptoms, plasmapheresis is transiently performed as an add-on treatment
with the expectation for early amelioration of them.
Because of the involvement of extracorporeal circulation, however, plasmapheresis
produces a major physical burden on the patient and is hence considered to be somewhat
difficult to perform on pediatric patients, elderly patients, and other patients in poor generalcondition. Additionally, the necessity for special equipment and a team of highly skilled
medical staff poses limitations on the availability of facilities where plasmapheresis can beperformed, and other problems arise, such as difficulty with conduct during holiday andnight-time. For these reasons, patients and healthcare professionals have been in strong
demand for adding generalized myasthenia gravis to the indications of intravenous injection of
immunoglobulin preparations that can be conveniently administered by intravenous drip
infusion.
In the clinical studies of Venoglobulin® IH 5% for intravenous injection conducted in Japan
in patients with generalized myasthenia gravis judged to require plasmapheresis because oftheir symptoms difficult to control with existing remedies and therapies, the drug was aseffective as plasmapheresis in terms of clinical symptom ratings and the evaluation of basic
daily activity movements. As for safety, the drug was not shown to cause any unexpected
adverse reactions compared with those of immunoglobulin preparations that have beenreported so far.
Since approval was granted on the condition of a drug use investigation (postmarketing
all-case surveillance), we are determined to promptly collect data on the safety and efficacyof this product so as to promote its appropriate usage.
Enjoining approval of the expanded indication, we expect Venoglobulin® IH 5% forintravenous injection to contribute to better quality of life for patients with generalized
myasthenia gravis as a new option for drug therapy.

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