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MHRA grants Promising Innovative Medicine designation to UCB’s skin disease treatment

The Medicines and Healthcare Products Regulatory Agency (MHRA) has granted Promising Innovative Medicine (PIM) designation in the UK to UCB’s bimekizumab▼, a developmental treatment for adults with hidradenitis suppurativa (HS).

HS is a chronic, recurring, painful and debilitating inflammatory skin disease1,2. The main symptoms are nodules, abscesses, and pus-discharging fistulas (channels leading out of the skin) which typically occur in the armpits, groin, and buttocks1,2. People with HS experience flare-ups of the disease as well as severe pain, which can have a major impact on quality of life1,2.

The granting of a PIM designation is an early indication that an investigational treatment may be an eligible candidate for Early Access to Medicines (EAMS), which can provide patients with life threatening or seriously debilitating conditions pre-approval access to medicines where there is a clear unmet medical need. PIM is granted to products that meet all three of the following criteria3.

  • Criteria 1 – The condition is life-threatening or seriously debilitating with special emphasis on patient quality of life, and there is high unmet need as there is no method of treatment available or existing methods have serious limitations.
  • Criteria 2 – The medicinal product is likely to offer major advantage over current methods used in the UK.
  • Criteria 3 – The benefits of the medicinal products are likely to outweigh potential adverse effects.

HS is estimated to affect approximately 1% of the population in most studied countries and is three to four times more common in women than in men1,2. It develops in adulthood but how and why HS develops is not yet fully understood. Approximately one third of people with HS are genetically predisposed to it, and lifestyle factors such as smoking, and obesity can also play a crucial role in its development4.

Claire Brading, Managing Director, UCB UK said: “Hidradenitis suppurativa is a debilitating condition and we are delighted that the MHRA has recognised the potential of bimekizumab for patients living with the chronic pain of this disease. This is testament to our commitment to supporting patients with skin conditions in the UK and harnessing innovative science to do so.”

References

1 Jemec GBE. Clinical practice. Hidradenitis suppurativa. N Engl J Med. 2012;366(2):158-164

2 Sabat R, Jemec GBE, Matusiak L. et al. Hidradenitis suppurativa. Nat Rev Dis Primers. 2020;6:18.

3 MHRA. Promising Innovative Medicine (PIM) Designation – Step I of Early Access to Medicines Scheme (EAMS). Available at: PIM_designation_guidance.pdf (publishing.service.gov.uk). Accessed May 2023.

4 Kokolakis G, Wolk K, Schneider-Burrus S, et al. Delayed Diagnosis of Hidradenitis Suppurativa and Its Effect on Patients and Healthcare System. Dermatology. 2020;236:421–430.

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Emma Cooper
Emma Cooper
Emma is Content Manager at Pf Media.

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