Name/CompanyApproval Dates/Comments
Pembrolizumab for IV injection
Merck & Co.
The US FDA approved pembrolizumab, a PD-1 inhibitor, in February 2019 for the adjuvant treatment of patients with high-risk stage III melanoma with lymph node involvement following complete resection. This is the first anti-PD-1 therapy evaluated in the adjuvant setting across patients with stage IIIA, stage IIIB, and stage IIIC melanoma, and the fourth approval for pembrolizumab in skin cancers. The approval is based on findings from the pivotal Phase 3 EORTC 1325/ KEYNOTE-054 trial, in which adjuvant pembrolizumab led to a 43% reduction in the risk of disease recurrence or death compared with placebo.
Guselkumab for SC injection
In February 2019, the FDA approved Tremfya® (guselkumab) One-Press, a single-dose, patient-controlled injector for adults with moderate-to-severe plaque psoriasis. Tremfya® is a human anti-interleukin-23 monoclonal antibody and is the first FDA-approved medication of its kind to offer the One-Press patient-controlled injector.
Dupilumub for SC injection
The FDA approved an expanded indication for dupilumab, a fully human monoclonal antibody inhibitor of interleukin (IL)-4 and IL-13, in March 2019 for treating adolescent patients 12 to 17 years of age with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Regulatory approval was based on data from a pivotal Phase 3 trial showing that monotherapy was effective and safe in adolescents with uncontrolled moderate-to-severe AD. Patients reported average Eczema Area and Severity Index (EASI) improvements of 66% from baseline, compared to 24% in placebo-treated patients. The trial further demonstrated that about 24% of patients who received dupilumab achieved clear or almost clear skin, according to Investigator’s Global Assessment (IGA) scoring vs. 2% of patients on placebo. Another 42% of treated patients achieved EASI-75 (75% improvement) by the end of the trial, and 37% had clinically meaningful improvements in pruritus, vs. 8% and 5% of patients on placebo, respectively.
Risankizumab for SC injection
In March 2019, the Japanese Ministry of Health, Labour and Welfare (MHLW) approved risankizumab, an IL-23 inhibitor, for the treatment of plaque psoriasis, generalized pustular psoriasis, erythrodermic psoriasis, and psoriatic arthritis in adult patients who have an inadequate response to conventional therapies. This approval marks the first regulatory approval worldwide for risankizumab. This humanized immunoglobulin G1 (IgG1) monoclonal antibody has a 12-week dosing schedule and works by selectively inhibiting IL-23 by binding to its p19 subunit. Approval in Japan was based on efficacy and safety data from Phase 2 and Phase 3 clinical trials, sustaIMM, ultIMMa-1 and IMMspire, evaluating risankizumab in Japanese patients with plaque psoriasis, generalized pustular psoriasis and erythrodermic psoriasis, as well as a global Phase 2 study in patients with active psoriatic arthritis.

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