Merz Pharma and Teijin Pharma have announced that an additional approval has been granted by Japan’s Ministry of Health, Labor and Welfare (MHLW) to market Xeomin (incobotulinumtoxinA) for intramuscular injection in 50, 100 or 200 units for the treatment of lower limb spasticity.
This condition is a symptom of upper motor neuron syndrome, which is expressed mainly by increased muscle tone of limbs and the hyperexcitability of the stretch reflex as a sequela of stroke.
Stefan Brinkmann, chief executive of Merz Therapeutics, said: “The extended approval marks an important milestone for Merz Therapeutics and is the result of our close and trustful partnership with Teijin Pharma in Japan. We wish our partner a successful introduction of this important spasticity indication to the Japanese doctors and patients.”
Stefan Albrecht, senior vice president of Merz Therapeutics Global R&D, said: “This label extension in Japan is another outstanding example for the benefits Xeomin offers to many post-stroke spasticity patients.
“Physicians now have the choice to treat lower and upper limb spasticity, also in combination and with the flexibility to apply the individual dosage as needed. We are proud of this achievement and in particular of the excellent collaboration with our partner Teijin.”
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