brodalumab

{{Drugbox

| Verifiedfields = changed

| Watchedfields = changed

| verifiedrevid = 459982905

| type = mab

| image =

| alt =

| mab_type = mab

| source = u

| target = Interleukin 17 receptor A

| tradename = Siliq, Kyntheum, Lumicef

| Drugs.com =

| MedlinePlus =

| DailyMedID = Brodalumab

| pregnancy_AU =

| pregnancy_category=

| routes_of_administration =

| ATC_prefix = L04

| ATC_suffix = AC12

| legal_AU =

| legal_CA = Rx-only

| legal_CA_comment = /{{nbsp}}Schedule D{{Cite web |url=https://hpr-rps.hres.ca/reg-content/regulatory-decision-summary-detail.php?lang=en&linkID=RDS00365 |title=Regulatory Decision Summary for Siliq |date=23 October 2014 |access-date=10 June 2022 |archive-date=7 June 2022 |archive-url=https://web.archive.org/web/20220607073955/https://hpr-rps.hres.ca/reg-content/regulatory-decision-summary-detail.php?lang=en&linkID=RDS00365 |url-status=live }}

| legal_UK =

| legal_US = Rx-only

| legal_US_comment = {{cite web | title=Siliq- brodalumab injection | publisher=DailyMed | date=12 June 2020 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1a550c33-456a-4833-814e-8591aea7c688 | access-date=8 June 2022 | archive-date=18 March 2021 | archive-url=https://web.archive.org/web/20210318042617/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1a550c33-456a-4833-814e-8591aea7c688 | url-status=live }}

| legal_EU = Rx-only

| legal_EU_comment = {{cite web | title=Kyntheum EPAR | publisher=European Medicines Agency | date=17 September 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/kyntheum | access-date=8 June 2022 | archive-date=13 September 2021 | archive-url=https://web.archive.org/web/20210913144112/https://www.ema.europa.eu/en/medicines/human/EPAR/kyntheum | url-status=live }}

| legal_status = Rx-only

| bioavailability =

| protein_bound =

| metabolism =

| elimination_half-life =

| excretion =

| CAS_number = 1174395-19-7

| CAS_number_Ref = {{cascite|correct|CAS}}

| PubChem =

| DrugBank_Ref = {{drugbankcite|correct|drugbank}}

| DrugBank = DB11776

| ChemSpiderID_Ref = {{chemspidercite|changed|chemspider}}

| ChemSpiderID = none

| UNII_Ref = {{fdacite|correct|FDA}}

| UNII = 6ZA31Y954Z

| KEGG = D10061

| KEGG_Ref = {{keggcite|changed|kegg}}

| synonyms = KHK4827, AMG 827

| C=6372 | H=9840 | N=1712 | O=1988 | S=52

}}

Brodalumab, sold under the brand name Siliq in the US and Kyntheum in the EU, is a human monoclonal antibody designed for the treatment of inflammatory diseases.{{cite web|title=Statement On A Nonproprietary Name Adopted By The USAN Council: Brodalumab|publisher=American Medical Association|url=http://www.ama-assn.org/resources/doc/usan/brodalumab.pdf|access-date=8 September 2011|archive-date=1 February 2016|archive-url=https://web.archive.org/web/20160201010437/http://www.ama-assn.org/resources/doc/usan/brodalumab.pdf|url-status=live}}

In February 2017, it received US FDA approval to treat moderate to severe plaque psoriasis in people who have not improved with other treatments.{{cite press release|title=FDA approves new psoriasis drug|url=https://www.fda.gov/news-events/press-announcements/fda-approves-new-psoriasis-drug|publisher=U.S. Food and Drug Administration|access-date=18 February 2017|date=15 February 2017|archive-date=11 December 2019|archive-url=https://web.archive.org/web/20191211203533/https://www.fda.gov/news-events/press-announcements/fda-approves-new-psoriasis-drug|url-status=dead}}

Mechanism of action

Brodalumab binds to the interleukin-17 receptor and so prevents interleukin 17 (IL-17) from activating the receptor. This mechanism is similar to that of another anti-psoriasis antibody, ixekizumab, which however binds to IL-17 itself.

History

Brodalumab was developed by Amgen, Inc. as AMG 827.

In 2013, it was in two phase III clinical trials for the treatment of moderate to severe psoriasis.{{ClinicalTrialsGov|NCT01708590 |Study of Efficacy, Safety, and Withdrawal and Retreatment With Brodalumab in Moderate to Severe Plaque Psoriasis Subjects (AMAGINE-1)}}{{ClinicalTrialsGov|NCT01708629|Study of Efficacy and Safety of Brodalumab Compared With Placebo and Ustekinumab in Moderate to Severe Plaque Psoriasis Subjects (AMAGINE-3)}}

In November 2014, Amgen and AstraZeneca 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 and a placebo.{{Cite web | vauthors = Philippidis A |url=http://www.genengnews.com/gen-news-highlights/brodalumab-s-no-turkey-in-phase-iii-amgen-and-astrazeneca/81250645/ |title=Brodalumab's No Turkey in Phase III: Amgen and AstraZeneca | date = 26 November 2014 |access-date=27 November 2014 |archive-url=https://web.archive.org/web/20141203034950/http://www.genengnews.com/gen-news-highlights/brodalumab-s-no-turkey-in-phase-iii-amgen-and-astrazeneca/81250645/ |archive-date=3 December 2014 |url-status=dead | work = Genetic Engineering & Biotechnology News }}

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".{{cite press release|title=Amgen to terminate participation in co-development and commercialization of brodaluma|publisher=Amgen|url=http://www.amgen.com/media/media_pr_detail.jsp?releaseID=2052862|access-date=26 May 2015|archive-date=26 May 2015|archive-url=https://web.archive.org/web/20150526212558/http://www.amgen.com/media/media_pr_detail.jsp?releaseID=2052862|url-status=live}} 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 has rights to brodalumab and continued as KHK4827.

In September 2015, AstraZeneca announced a partnership with Valeant Pharmaceuticals in which Valeant took over exclusive rights to develop and commercialize brodalumab.{{cite press release|url=https://www.astrazeneca.com/media-centre/press-releases/2015/astrazeneca-valeant-pharmaceuticals-brodalumab-dermatology-psoriasis-01092015.html|title=AstraZeneca and Valeant Pharmaceuticals to partner on brodalumab|publisher=AstraZeneca|access-date=10 June 2022|archive-date=4 October 2021|archive-url=https://web.archive.org/web/20211004055335/https://www.astrazeneca.com/media-centre/press-releases/2015/astrazeneca-valeant-pharmaceuticals-brodalumab-dermatology-psoriasis-01092015.html|url-status=live}} In July 2016, the rights to commercialize brodalumab in Europe were sold to LEO Pharma.{{cite press release|url=https://www.astrazeneca.com/media-centre/press-releases/2016/astrazeneca-enters-licensing-agreements-with-leo-pharma-in-skin-diseases-01072016.html|title=AstraZeneca enters licensing agreements with LEO Pharma in skin diseases|publisher=AstraZeneca|access-date=16 November 2016|archive-date=3 October 2021|archive-url=https://web.archive.org/web/20211003152001/https://www.astrazeneca.com/media-centre/press-releases/2016/astrazeneca-enters-licensing-agreements-with-leo-pharma-in-skin-diseases-01072016.html|url-status=live}}

In January 2016, a biologics license application (BLA) was submitted to the US FDA.{{cite web|url=https://seekingalpha.com/news/3048846-fda-accepts-astrazenecas-brodalumab-bla-plaque-psoriasis-pdufa-date-november-16|title=FDA accepts AstraZeneca's brodalumab BLA for plaque psoriasis, PDUFA date November 16|vauthors=House DW|date=25 January 2016|website=Seeking Alpha|access-date=10 June 2022|archive-date=8 February 2017|archive-url=https://web.archive.org/web/20170208070537/http://seekingalpha.com/news/3048846-fda-accepts-astrazenecas-brodalumab-bla-plaque-psoriasis-pdufa-date-november-16|url-status=live}} Approval followed in February 2017.

References

Category:Amgen