Spesolimab, sold under the brand name Spevigo, is a
monoclonal antibody
A monoclonal antibody (mAb, more rarely called moAb) is an antibody produced from a cell Lineage made by cloning a unique white blood cell. All subsequent antibodies derived this way trace back to a unique parent cell.
Monoclonal antibodies ...
used for the treatment of
generalized pustular psoriasis (GPP).
It is an interleukin-36 receptor (IL-36R) antagonist.
It is given via injection into a vein.
The most common adverse reactions include fatigue, nausea and vomiting, headache,
pruritus
Itch (also known as pruritus) is a sensation that causes the desire or reflex to scratch. Itch has resisted many attempts to be classified as any one type of sensory experience. Itch has many similarities to pain, and while both are unpleasant ...
(itching) and
prurigo
Prurigo is an itchy eruption of the skin.
Specific types include:
* Prurigo nodularis
* Actinic prurigo
* Besnier's prurigo (a specific type of atopic dermatitis
Atopic dermatitis (AD), also known as atopic eczema, is a long-term type of inf ...
(itchy bumps), bruising, and urinary tract infection.
It was approved for medical use in the United States in September 2022,
and in European Union in December 2022.
The US
Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...
(FDA) considers it to be a
first-in-class medication A first-in-class medication is a pharmaceutical that uses a "new and unique mechanism of action" to treat a particular medical condition. While the Food and Drug Administration's Center for Drug Evaluation and Research tracks first-in-class medica ...
.
[ ]
Medical uses
Spesolimab is
indicated
In medicine, an indication is a valid reason to use a certain test, medication, procedure, or surgery. There can be multiple indications to use a procedure or medication. An indication can commonly be confused with the term diagnosis. A diagnosis ...
for the treatment of generalized pustular psoriasis flares in adults.
History
The US
Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...
(FDA) approved spesolimab based on evidence from a clinical trial of 53 adults with generalized pustular psoriasis flare.
The trial was conducted at three sites in the United States and 23 sites globally (Africa, Asia, and Europe).
Spesolimab was evaluated in one clinical trial (Study Effisayil-1/NCT03782792) of 53 adults with generalized pustular psoriasis flare.
In the trial, participants received a single treatment with either spesolimab or placebo.
Participants were evaluated for clearance of pustules based on a Generalized Pustular Psoriasis Physician Global Assessment (GPPPGA) pustulation sub score of 0 (indicating no visible pustules) at Week 1.
Neither the participant nor the healthcare providers knew which treatment was being given until after week 1.
After week 1, all participants, whether they initially received spesolimab or placebo, who continued to experience flare symptoms, had the option to receive a single open-label treatment of spesolimab (second treatment and first treatment for participants in the spesolimab and placebo groups, respectively).
After week 1 to week 12, participants in either original treatment group whose generalized pustular psoriasis flare reoccurred after achieving a clinical response were eligible to receive a single open-label rescue treatment of spesolimab, with a maximum of three total treatments of spesolimab throughout the trial.
[ ]
Society and culture
Legal status
In October 2022, the
Committee for Medicinal Products for Human Use
The Committee for Medicinal Products for Human Use (CHMP), formerly known as Committee for Proprietary Medicinal Products (CPMP), is the European Medicines Agency's committee
A committee or commission is a body of one or more persons subordin ...
(CHMP) of the
European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a conditional marketing authorization for the medicinal product Spevigo, intended for the treatment of flares in adult patients with generalised pustular psoriasis.
The applicant for this medicinal product is Boehringer Ingelheim International GmbH.
[ Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.] Spesolimab was approved for medical use in the European Union in December 2022.
[ Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.]
References
External links
*
Drugs developed by Boehringer Ingelheim
Monoclonal antibodies
Orphan drugs
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