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Risankizumab-rzaa granted FDA approval

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On April 23, 2019, the US Food and Drug Administration approved risankizumab-rzaa (SKYRIZI™) for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Risankizumab is a humanized IgG1 monoclonal antibody that inhibits interleukin (IL)-23, a cytokine involved in inflammatory processes, by binding to its p19 subunit. SKYRIZI is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization of SKYRIZI globally.

The product’s approval is supported by data from four randomized, placebo and/or active-controlled pivotal studies, ultIMMA-1, ultIMMa-2, IMMhance and IMMvent, that evaluated the safety and efficacy of risankizumab in more than 2,000 patients with moderate-to-severe chronic plaque psoriasis. The co-primary endpoints of the studies were Psoriasis Area and Severity Index and static Physician Global Assessment [sPGA] score of clear or almost clear [sPGA 0/1] at 16 weeks versus placebo. In these four studies, all co-primary and ranked secondary outcome measures were met and no new safety signals were observed. Results of the UltIMMa-1 (NCT02684370) and UltIMMa-2 (NCT02684357) studies were reported in The Lancet. Risankizumab was previously approved in Japan and Canada, and a marketing authorization application for risankizumab is currently undergoing regulatory review in the European Union.

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The Antibody Society maintains a comprehensive table of approved mAb therapeutics and those in regulatory review in the EU or US. Please log in to access the table, which is located in the Members Only section and can be downloaded in Excel format. Information about other antibody therapeutics that may enter regulatory review in 2019 can be found in ‘Antibodies to watch in 2019’.

Romosozumab-aqqg granted FDA approval

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On April 9, 2019, the US Food and Drug Administration approved romosozumab-aqqg (Evenity) to treat osteoporosis in postmenopausal women at high risk of bone fractures. Developed by Amgen and UCB, romosozumab is a humanized IgG2 monoclonal antibody that targets sclerostin. This is the second global approval of romosozumab, following its approval in Japan.

FDA’s approval was based the results of the Phase 3 placebo-controlled FRAME and active-controlled ARCH studies. As reported by Amgen, treatment with EVENITY resulted in a significant reduction of new vertebral fracture at 12 months compared to placebo in the FRAME study. This significant reduction in fracture risk persisted through the second year in women who received EVENITY during the first year and transitioned to denosumab compared to those who transitioned from placebo to denosumab. In addition, EVENITY significantly increased bone mineral density (BMD) at the lumbar spine, total hip and femoral neck compared to placebo at 12 months. Following the transition from EVENITY to denosumab at month 12, BMD continued to increase through month 24.

In the ARCH study, treatment with EVENITY for 12 months followed by 12 months of alendronate significantly reduced the incidence of new vertebral fracture at 24 months. EVENITY followed by alendronate significantly reduced the risk of clinical fracture (defined as a composite of symptomatic vertebral fracture and nonvertebral fracture) after a median follow-up of 33 months. EVENITY significantly increased BMD at the lumbar spine, total hip and femoral neck at 12 months compared to alendronate. Twelve months of treatment with EVENITY followed by 12 months of treatment with alendronate significantly increased BMD compared with alendronate alone.

The European Medicines Agency is reviewing a marketing application for romosozumab.

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The Antibody Society maintains a comprehensive table of approved mAb therapeutics and those in regulatory review in the EU or US. Please log in to access the table, which is located in the Members Only section and can be downloaded in Excel format. Information about other antibody therapeutics that may enter regulatory review in 2019 can be found in ‘Antibodies to watch in 2019’.

First approval for risankizumab

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AbbVie has announced that SKYRIZI (risankizumab) was granted its first approval. The Japanese Ministry of Health, Labour and Welfare approved risankizumab 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. AbbVie is leading the development and commercialization of SKYRIZI, which is included in a collaboration with Boehringer Ingelheim.

Risankizumab is a humanized IgG1 monoclonal antibody that targets IL-23. The approval in Japan is based on efficacy and safety data from Phase 2 and Phase 3 clinical trials, sustaIMM, ultIMMa-1 and IMMspire, evaluating SKYRIZI 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.

Marketing applications were submitted for risankizumab in both the EU and US, and regulatory decisions are anticipated in the first half of 2019. The European Medicines Agency’s Committee for Medicinal Products for Human Use has announced that it adopted a positive opinion for SKYRIZI for treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy.

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The Antibody Society maintains a comprehensive table of approved mAb therapeutics and those in regulatory review in the EU or US. Please log in to access the table, which is located in the Members Only section and can be downloaded in Excel format. Information about other antibody therapeutics that may be approved or enter regulatory review in 2019 can be found in ‘Antibodies to watch in 2019’.

FDA approval for caplacizumab-yhdp

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On February 6, 2019, the US Food and Drug Administration approved caplacizumab-yhdp (Cablivi), in combination with plasma exchange and immunosuppressive therapy, for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP). During episodes of this rare, life-threatening blood clotting disorder, microclots can form, leading to low platelet counts, ischemia and organ dysfunction in aTTP patients.  Approval was based on positive results from a study of 145 patients with an acute episode of aTTP who were randomized 1:1 to receive either caplacizumab or placebo in addition to standard-of-care treatment, which was daily plasma exchange and immunosuppression. Caplacizumab was granted its first approved in the European Union (EU) on August 31, 2018. The mAb was granted Fast Track designation in the US and Orphan Drug designations in the US and EU for the treatment of aTTP.

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The Antibody Society maintains a comprehensive table of approved mAb therapeutics and those in regulatory review in the EU or US. Please log in to access the table, which is located in the Members Only section and can be downloaded in Excel format.

First approval for romosozumab

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Japan’s Ministry of Health, Labor and Welfare has granted a marketing authorization for romosozumab (EVENITY) for the treatment of osteoporosis in patients at high risk of fracture. Developed by Amgen and UCB, romosozumab is a humanized IgG2 monoclonal antibody that targets sclerostin. The approval in Japan is based on results from the Phase 3 FRAME and BRIDGE studies, which included 7,180 postmenopausal women with osteoporosis and 245 men with osteoporosis, respectively.

A biologics license application (BLA) for romosozumab as a treatment of osteoporosis in postmenopausal women at high risk for fracture was submitted to the U.S. Food and Drug Administration (FDA) in July 2016, but additional safety and efficacy data was requested in the FDA’s complete response letter, as announced by Amgen and UCB in July 2017. In July 2018, Amgen and UCB announced that the BLA had been resubmitted. In addition to data from early-stage clinical studies, the original BLA included data from the Phase 3 FRAME study. The resubmitted BLA includes results from the more recent Phase 3 ARCH study, an alendronate-active comparator trial including 4,093 postmenopausal women with osteoporosis who experienced a fracture, and the Phase 3 BRIDGE study. The FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee is scheduled to review data supporting the BLA for romosozumab at a meeting on January 16, 2019.

The European Medicines Agency is also currently reviewing a marketing application for romosozumab.

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The Antibody Society maintains a comprehensive table of approved antibody therapeutics and those in regulatory review in the EU or US. Please log in to access the table, which is located in the Members Only section and can be downloaded in Excel format.