Brodalumab, sold under the brand name Siliq in the US and Kyntheum in the EU, is a human

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 ...

designed for the treatment of inflammatory diseases. In February 2017, it received US FDA approval to treat moderate to severe

plaque psoriasis Psoriasis is a long-lasting, noncontagious autoimmune disease characterized by raised areas of abnormal skin. These areas are red, pink, or purple, dry, itchy, and scaly. Psoriasis varies in severity from small, localized patches to complete ...

in people who have not improved with other treatments.

Mechanism of action

Brodalumab binds to the interleukin-17 receptor and so prevents

interleukin 17 Interleukin 17 family (IL17 family) is a family of pro-inflammatory cystine knot cytokines. They are produced by a group of T helper cell known as T helper 17 cell in response to their stimulation with IL-23. Originally, Th17 was identif ...

(IL-17) from activating the receptor. This mechanism is similar to that of another anti-psoriasis antibody,

ixekizumab Ixekizumab, sold under the brand name Taltz, is an injectable medication for the treatment of autoimmune diseases. Chemically, it is a form of a humanized monoclonal antibody. The substance acts by binding interleukin 17A and neutralizing it, re ...

, which however binds to IL-17 itself.

History

Brodalumab was developed by

Amgen Amgen Inc. (formerly Applied Molecular Genetics Inc.) is an American multinational biopharmaceutical company headquartered in Thousand Oaks, California. One of the world's largest independent biotechnology companies, Amgen was established in T ...

, Inc. as AMG 827. In 2013, it was in two phase III clinical trials for the treatment of moderate to severe psoriasis. In November 2014, Amgen and

AstraZeneca AstraZeneca plc () is a British-Swedish multinational pharmaceutical and biotechnology company with its headquarters at the Cambridge Biomedical Campus in Cambridge, England. It has a portfolio of products for major diseases in areas includi ...

reported encouraging results for the compound. The companies stated that the compound met the primary endpoint showing superior skin clearance in a Phase III trial when compared to

ustekinumab Ustekinumab, sold under the brand name Stelara is a monoclonal antibody medication developed by Janssen Pharmaceuticals, for the treatment of Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis, targeting both IL-1 ...

and a placebo. However, in May 2015, Amgen announced that it was ending its participation in co-development of the compound because of reports of patients having "events of suicidal ideation and behavior". AstraZeneca will be solely responsible for any future development and marketing of brodalumab in all territories except for certain Asian territories such as Japan, where

Kyowa Hakko Kirin is a Japanese pharmaceutical and biotechnology company under the Kirin Holdings, and is among the 40 largest in the world by revenue. The company is headquartered in Chiyoda-ku, Tokyo and is a member of the Nikkei 225 stock index. History On ...

has rights to brodalumab and continued as KHK4827. In September 2015, AstraZeneca announced a partnership with

Valeant Pharmaceuticals Bausch Health Companies Inc. (formerly Valeant Pharmaceuticals International, Inc.) is a Canadian multinational specialty pharmaceutical company based in Laval, Quebec, Canada. It develops, manufactures and markets pharmaceutical products a ...

in which Valeant took over exclusive rights to develop and commercialize brodalumab. In July 2016, the rights to commercialize brodalumab in Europe were sold to

LEO Pharma LEO Pharma A/S is a multinational Danish pharmaceutical company, founded in 1908, with a presence in about 100 countries. Its headquarters are in Ballerup, near Copenhagen The company is 100% integrated into a private foundation owned by the LEO F ...

. In January 2016, a

biologics license application A biologics license application (BLA) is defined by the U.S. Food and Drug Administration (FDA) as follows: The biologics license application is a request for permission to introduce, or deliver for introduction, a biologic product into inter ...

(BLA) was submitted to the US FDA. Approval followed in February 2017.

References

External links

* Amgen {{monoclonal-antibody-stub