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28783411000001108

New Medicines

OtezlaBehcet disease in adults

Information

Otezla
Licence extension / variation
Amgen
Amgen

Development and Regulatory status

Launched
Launched
Launched
April 2020
Apr 20Approved in EU [11,12].
Feb 20Recommended for EU approval by CHMP - the additional indication is ”for the treatment of adult patients with oral ulcers associated with Behçet’s disease (BD) who are candidates for systemic therapy” [10].
Aug 19Celgene have sold Otezla to Amgen.
Jul 19Approved in the US for the treatment of adult patients with oral ulcers associated with Behçet’s Disease [6]
Jul 19Celgene has a target action date of July 21 for its supplemental NDA of apremilast in Behcet’s disease. [6]
Oct 18Supplementary NDA submitted to FDA before Oct 18 [5].
Jul 16PIII [2].

Category

Inhibits multiple pro-inflammatory mediators including, TNF-alpha, interleukins 6, 17 and 23, and interferon-gamma.
This condition is not commonly seen in Northern Europeans. Prevalence is highest in the Middle East, Mediterranean and Eastern Asia. Prevalence is 80 to 370 cases per 100,000 population in Turkey, 10 per 100,000 in Japan and 0.6 per 100,000 in Yorkshire. European cases are more often described - but not exclusively - in the migrant population [1].
Behcet disease in adults
Oral

Trial or other data

Nov 19Results of PIII (NCT02307513) study are published in NEJM. RCT (n=207) found that apremilast resulted in a greater reduction in the number of oral ulcers than placebo at 12 weeks (AUC for total number of oral ulcers = 129.5 vs. 222, respectively; p<0.001) but treatment was linked to ADRs including diarrhoea, nausea, and headache [8].
Feb 18Celgene present data from PIII RELIEF study (n=207). At week 12, AUC for number of oral ulcers was statistically significantly reduced with apremilast 30 mg bd vs placebo (129.5 vs. 222.1; P<0.0001), the trial’s primary endpoint [4].
Dec 14PIII (NCT02307513) study to test whether apremilast is better than placebo for treatment of oral ulcers in subjects with active Behçet´s disease starts. Other manifestations of the disease will also be assessed, such as, pain and tenderness in joints, eye inflammation, genital ulcers, and skin disease. This study also will test how well the body tolerates apremilast. 204 subjects will be recruited from sites in countires such as US, Turkey, France, Germany Japan and Israel. The placebo-controlled period will be 12 weeks long and patients will receive apremilast or placebo. After the 12-week placebo-controlled period, all subjects will receive apremilast for 1 year. Collection of primary outcome data (Oral Ulcers at 12 weeks) will complete Mar 18 [3].

Evidence based evaluations

OtezlaGenital plaque psoriasis in adults

Information

Otezla
Licence extension / variation
Amgen
Amgen

Development and Regulatory status

None
Phase III Clinical Trials
Phase III Clinical Trials

Category

Inhibits multiple pro-inflammatory mediators including, TNF-alpha, interleukins 6, 17 and 23, and interferon-gamma.
Genital psoriasis prevalence ranges from 7% to 42% and prevalence at any time during the course of psoriasis ranges from 33% to 63%. In two prospective clinical trials, the prevalence of genital psoriasis at the time of enrollment was 35-42% [1].
Genital plaque psoriasis in adults
Oral

OtezlaMild-to-moderate plaque psoriasis in adults

Information

Otezla
Licence extension / variation
Amgen
Amgen

Development and Regulatory status

None
None
Pre-registration (Filed)
May 21US FDA accepts sNDA and assigns a PDUFA date of 19/12/21 [9].
Feb 21Filed in US in adults with mild-to-moderate plaque psoriasis who are candidates for phototherapy or systemic therapy [8].
Dec 20Amgen currently has no plans to apply for a licence in the UK for apremilast to treat mild to moderate plaque psoriasis [7].

Category

Inhibits multiple pro-inflammatory mediators including, TNF-alpha, interleukins 6, 17 and 23, and interferon-gamma.
Prevalence of psoriasis is estimated to be about 1.3-2.2% in the UK, with the highest prevalence being in white people. Plaque psoriasis accounts for 90% of all people with psoriasis [1].
Mild-to-moderate plaque psoriasis in adults
Oral

OtezlaPlaque psoriasis in children aged 6 to 17 years

Information

Otezla
Licence extension / variation
Amgen
Amgen

Development and Regulatory status

None
Phase III Clinical Trials
Phase III Clinical Trials

Category

Inhibits multiple pro-inflammatory mediators including, TNF-alpha, interleukins 6, 17 and 23, and interferon-gamma.
Prevalence of psoriasis in childhood in the UK is about 0.55 % in children aged 0–9 years and 1.37 % in children aged 10–19 years [1].
Plaque psoriasis in children aged 6 to 17 years
Oral

OtezlaPlaque psoriasis of the scalp in adults

Information

Otezla
Licence extension / variation
Amgen
Amgen

Development and Regulatory status

None
None
Launched
Apr 20FDA approves the sNDA provides for updates to the Adverse Reactions and Clinical Studies sections of labeling with safety and efficacy information for moderate to severe plaque psoriasis of the scalp [5].
Jan 20FDA assigns a Prescription Drug User Fee Act target action date of April 2020 for the sNDA for aprelimast for treatment of adult patients with moderate to severe plaque psoriasis of scalp [4].
Aug 19Celgene have sold Otezla to Amgen [3].
Jun 19Filed in the US, based on STYLE results [4].

Category

Inhibits multiple pro-inflammatory mediators including, TNF-alpha, interleukins 6, 17 and 23, and interferon-gamma.
Psoriasis vulgaris affects 1-3% of the general population [5], with the scalp being the most common site of involvement, at the onset and throughout the course of the disease. Prevalence of scalp psoriasis is 1.5% to 2% in northwestern Europe [1].
Plaque psoriasis of the scalp in adults
Oral

Trial or other data

Aug 18PIII STYLE study meets its primary endpoint [3].
May 17PIII STYLE trial to evaluate the efficacy and safety of apremilast in 300 patients with plaque psoriasis of the scalp in the US and Canada starts (NCT03123471). Primary outcoem is Scalp Physician’s Global Assessment (ScPGA) response; collection of these data is due to complete Aug 18 [2].

Evidence based evaluations