The US Food and Drug Administration recently became the first regulatory authority to approve spesolimab as a treatment option for generalised pustular psoriasis (GPP) flares in adults.
GPP is a rare disease, and its impact on those affected is immense. Patients experience widespread non-infectious pustules erupting on the skin, which are red, itchy, painful and visible to others.
To help combat the disease, Boehringer Ingelheim launched spesolimab, a novel, selective antibody that blocks the activation of the interleukin-36 receptor (IL-36R), a signaling pathway within the immune system shown to be involved in the pathogenesis of GPP.
Innovative therapies
Mohammed Al-Tawil, Regional Managing Director and Head of Human Pharma at Boehringer Ingelheim for India, Middle East, Turkey, and Africa (IMETA) region, Boehringer Ingelheim, said: "At Boehringer Ingelheim, we remain steadfast in our commitment to developing and delivering our innovative therapies for patients living with rare irreversible conditions such as GPP.
“Patients living with GPP may experience flares that can lead to serious complications requiring them to seek medical attention. With this important approval, we will be able to bring the next generation of scientific breakthroughs to the GPP patient community who, until now, have not had any approved treatments and help them manage their condition."
The FDA’s approval of spesolimab is based on results from the pivotal EFFISAYIL 1 Phase II clinical trial. In the 12-week trial, patients experiencing a GPP flare were treated with spesolimab or placebo. Most patients at the outset of the trial had a high, or very high, density of pustules and impaired quality of life. After one week, 54% of patients treated with spesolimab showed no visible pustules compared to placebo (6%).
Profound impact
Dr Mohamed Meshref, Medical Director for IMETA region, Boehringer Ingelheim, said: “GPP is a dermatological condition that can have a profound impact on patients' quality of life. Flares associated with GPP are common in people living with this devastating skin condition and if left untreated, they can be life-threatening. This approval by the US FDA is a turning point and will help make a difference for patients living with the rare condition reinforcing Boehringer Ingelheim’s commitment to elevating standards of patient care."
In addition to the US approval, spesolimab is currently under review by several other regulatory authorities. To date, spesolimab has received Breakthrough Therapy Designation in the US, China, and Taiwan, Priority Review in the US and China, Orphan Drug Designation in the US, Korea, Switzerland, and Australia, Rare Disease Designation, and fast track in Taiwan, for the treatment of GPP flares. The European Medicines Agency validated the marketing authorisation application for spesolimab in GPP in October 2021, and the submission is currently under evaluation.-- TradeArabia News Service
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