Malaysia gives nod to Boehringer Ingelheim's Spesolimab for treatment of Generalised Pustular Psoriasis flares in adults

The National Pharmaceutical Regulatory Agency (NPRA) Malaysia has approved Boehringer Ingelheim's Spesolimab (marketed as SPEVIGO) for the treatment of flares in adults with generalised pustular psoriasis (GPP), the first indicated treatment of its kind in Malaysia.

Spesolimab is a novel, humanised, selective antibody which inhibits the activation of the interleukin-36 receptor (IL36R), a signalling pathway within the immune system that is involved in the pathogenesis of GPP.

In Malaysia, the prevalence of GPP is 198 per million, affecting 267 women compared to 127 men. It has a particularly high prevalence among the Chinese population in Malaysia, affecting 271 per million, compared to Malay and Indian ethnicities at 186 per million and 179 per million respectively

The approval of Spesolimab (marketed as SPEVIGO) in Malaysia follows the breakthrough findings of the EFFISAYIL 1 trial, which demonstrated that after just one week, 54% of patients treated with Spesolimab showed no visible pustules, compared to those treated with placebo (6%).

Dr Mohd Azhar Ahmad, Head of Medicine, Boehringer Ingelheim Malaysia, Singapore and Indonesia, says, “GPP has a devastating impact on patients, and their families. Until Spesolimab, there were no approved therapies in Malaysia designed specifically to treat GPP flares in adults, which may have resulted in poor management of the disease with potentially life-threatening complications. Spesolimab is an innovative treatment that works by inhibiting the mechanism that causes the flares in the first place, thus helping patients to manage the impact of their flares and significantly improving their quality of life.”