CHMP adopts positive opinion recommending approval of new and expanded indications for SPEVIGO®
2024年7月29日 - 3:05PM
- The CHMP positive opinion is based on the EFFISAYIL® 2 trial,
which showed that no flares were observed after week 4 of SPEVIGO®
administered subcutaneously. During the 48-week trial, an 84%
reduction of the risk of GPP flares was observed.
- GPP is a rare, chronic, heterogenous neutrophilic inflammatory
disease associated with skin flares and systemic symptoms, such as
fever, pain, and fatigue.
- SPEVIGO® is currently approved in 51 countries for treatment of
GPP flares, and the CHMP opinion follows similar approvals for
expanded and new indications in the US and China.
Boehringer Ingelheim today announced that the European Medicine
Agency’s Committee for Medicinal Products for Human Use (CHMP)
recommended approval of a new indication of SPEVIGO® (spesolimab)
injection for the prevention of generalized pustular psoriasis
(GPP) flares in adults and adolescents from 12 years of age; and
extension of the approved indication for SPEVIGO® (spesolimab)
infusion for the treatment of generalized pustular psoriasis (GPP)
flares in adults and adolescents from 12 years of age as
monotherapy. SPEVIGO® is a novel, humanized selective IgG1 antibody
that binds to interleukin-36 receptor (IL-36R), a key part of a
signaling pathway within the immune system shown to be involved in
the cause of GPP.
The regulatory authorities’ decisions are based on the positive
results of the EFFISAYIL® 2 trial, a 48-week clinical trial that
showed that SPEVIGO® significantly reduced the risk of GPP flares
by 84%, compared with placebo. In the trial with 123 patients, no
flares were observed after week 4 of SPEVIGO® subcutaneous
treatment in the high-dose group (n=30). The EFFISAYIL® 2 trial
showed a similar incidence of patients with adverse events across
spesolimab and placebo treatment arms.
“GPP presents a significant diagnostic challenge for healthcare
professionals as it is a highly variable rare disease that is
experienced differently by everyone who has it, and it has suffered
from a historic lack of treatment options,” said Dr Peter van der
Kerkhof, Professor and previous Chairman of the Department of
Dermatology, Radboud University Nijmegen Medical Centre, Nijmegen,
the Netherlands. “Spesolimab’s recent approvals, combined with the
CHMP recommendation provides us with the potential for continuous
treatment, addressing a significant unmet need.”
Distinct from plaque psoriasis, GPP is a rare, chronic,
heterogenous, inflammatory neutrophilic disease associated with
painful skin manifestations and systemic symptoms, such as fever,
pain, and fatigue. GPP varies widely between individuals living
with the condition, with symptoms presenting both above and below
the skin. Uncontrolled GPP may require emergency care and can lead
to life-threatening complications, such as multi-organ failure and
sepsis. GPP’s unpredictable nature can potentially have significant
long-term impacts on quality of life for people living with it and
leads to fear and anxiety over the disease course.
“The CHMP’s positive opinion on SPEVIGO®, alongside approvals in
China and the US, signals a strong shift in treatment, offering
people living with the disease the potential for significant
improvement of their condition and a better quality of life,” said
Carinne Brouillon, Member of the Board of Managing Directors and
Head of Human Pharma at Boehringer Ingelheim. “The potential to
prevent GPP flare-ups means a possibility to gain back control over
how people affected by the disease live their lives.”
"GPP goes way beyond the skin, it's a relentless and
unpredictable disease that can impact every aspect of a person's
life,” said Frida Dunger, Executive Director, IFPA (International
Federation of Psoriasis Associations). “I want a world where every
person with GPP is diagnosed quickly and receives the treatment
they need, and this is their right. There is much more to do, but I
believe with all stakeholders working together we are headed in the
right direction.”
About SPEVIGO®SPEVIGO® is a novel, humanized, selective
antibody that specifically blocks the activation of the IL-36R, a
signaling pathway within the immune system shown to be involved in
the pathogenesis of several autoinflammatory diseases, including
GPP. It is the first targeted therapy for the treatment of GPP and
has been evaluated in the largest clinical program specifically for
the treatment of patients with GPP.
About generalized pustular psoriasis (GPP)GPP is a
chronic, heterogenous, neutrophilic inflammatory disease associated
with skin and systemic symptoms that is distinct from plaque
psoriasis. GPP is recognized as a separate clinical entity from
other forms of psoriasis, with the IL-36 pathway being a key driver
of GPP and triggering response to treatment. Prevalence of GPP
varies considerably across geographical regions, ranging from 1.76
to 124 patients per million persons. GPP can become
life-threatening (mortality rates ranging from 2% to 16%) due to
severe complications, such as multisystem organ failure and sepsis
requiring urgent hospital care; many GPP patients also suffer from
various comorbidities, which contribute to the ongoing burden for
the patient and healthcare systems. GPP symptoms appear
unpredictable and present on a continuum, which greatly impacts a
patient’s quality of life, and may cause fear and anxiety over the
disease course, as well as long-term impacts on quality of life
related to work/school, emotional health, social activities, and
finances.
About the EFFISAYIL® clinical trial programThe
EFFISAYIL® clinical trial program evaluated the largest and
broadest population of GPP patients in trials of a therapy
specifically targeting the IL-36 pathway for GPP.
- EFFISAYIL® 1: A Phase II study that demonstrated
treatment with a single intravenous dose of spesolimab
significantly improved signs and symptoms of GPP in patients
experiencing a flare, including rapid pustular and skin clearance.
These results supported the approval of spesolimab as the first
specific treatment for GPP flares in adults in major markets.
- EFFISAYIL® 2: A Phase IIb study that showed subcutaneous
spesolimab significantly reduced the risk of GPP flares by 84% over
48 weeks compared to placebo. In the trial with 123 patients, no
flares were observed after week 4 of spesolimab SC treatment in the
high-dose group (n=30).
- EFFISAYIL®
ON: An open-label extension study to evaluate the long-term
safety and efficacy of spesolimab in patients with GPP who have
completed previous spesolimab trials.
- EFFISAYIL® REP
(ongoing): An open-label, single-arm, Phase IIIb/IV trial to
evaluate the efficacy, safety, and the impact of immunogenicity in
the treatment of patients with GPP presenting with a recurrent
flare following their initial GPP flare treatment with spesolimab
IV.
About Boehringer IngelheimBoehringer Ingelheim is a
biopharmaceutical company active in both human and animal health.
As one of the industry’s top investors in research and development,
the company focuses on developing innovative therapies that can
improve and extend lives in areas of high unmet medical need.
Independent since its foundation in 1885, Boehringer takes a
long-term perspective, embedding sustainability along the entire
value chain. More than 53,500 employees serve over 130 markets to
build a healthier, more sustainable, and equitable tomorrow. Learn
more at https://www.boehringer-ingelheim.com/.