UK’s MHRA expands approval for Merz TherapeuticsMerz Therapeutics’ XEOMIN
08 Jun 2023
Drug Approval
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Source: Pharmaceutical Technology
Merz Therapeutics’ XEOMIN is injected intramuscularly to improve muscle tone. Credit: Mufid Majnun on Unsplash.
The UK’s medicines and healthcare products regulatory agency (MHRA) has granted approval for a new indication for Merz Therapeutics’ XEOMIN (incobotulinumtoxinA) to treat focal spasticity of the lower limbs affecting the ankle joint.
The therapy was previously approved in the UK to treat upper limb spasticity.
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The expanded approval allows the company to provide holistic support to those living with spasticity who need comprehensive treatment.
The active ingredient in XEOMIN is incobotulinumtoxinA. It is injected intramuscularly to improve muscle tone.
The therapy blocks nerve impulses to the muscles to weaken voluntary muscle contraction. It relieves abnormal muscle tone by inhibiting the release of acetylcholine from the peripheral nerve endings.
Merz Therapeutics stated that XEOMIN can now be used to treat lower and upper limbs individually or simultaneously, by adjusting the dose as required.
Merz Therapeutics CEO Stefan König stated: “The label extension in the UK is an important step for Merz TherapeuticsMerz Therapeutics and the patients that we serve.
“With the UK becoming the second market, following Japan, to grant approval for the treatment of lower limb spasticity affecting the ankle joint, it establishes the UK as the pioneering European country in this area.”
The company noted that 400 units per injection is the maximum dose of XEOMIN required to treat lower limbs. 500 units is the maximum dose for the combined treatment of upper and lower limb spasticity.
XEOMIN has already received approval in more than 75 countries across the world for the treatment of blepharospasm, cervical dystonia, upper and lower limb spasticity and sialorrhea.
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