MHRA grants PIM designation to UCB's zilucoplan for myasthenia gravis

17 February 2022

The UK Medicine and Healthcare Products Regulatory Agency has granted Promising Innovative Medicine (PIM) designation to Belgian drugmaker UCB’s (Euronext: UCB) zilucoplan for the treatment of adults with generalized myasthenia gravis (gMG).

The granting of a PIM designation is an early indication that an investigational treatment may be made available to patients with life threatening or seriously debilitating conditions where there is a clear unmet medical need, through the Early Access to Medicines Scheme
This designation makes zilucoplan the first investigational treatment with a published PIM designation for gMG in the UK
gMG is a rare, chronic auto-immune disease that disrupts the way the nerves communicate with the muscles. There are an estimated 12,000 people in the UK living with the disease, who experience a variety of symptoms because of the condition, including drooping eyelids, double vision, and difficulty swallowing, chewing and eating

Claire Brading, managing director and head of neurology UCB UK & Ireland said: “Myasthenia gravis is a serious condition that can have unpredictable and debilitating symptoms, affecting patients’ lives in multiple ways. We are pleased that zilucoplan has been recognized by the MHRA for its potential to address the urgent need for treatment innovation in this area. This is testament to UCB’s commitment to MG patients in the UK, as well as to harnessing science to bring benefit to people living with rare diseases more widely.”

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