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The Antibody Society

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FDA approves brolucizumab-dbll (BEOVU®)

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On October 7, 2019, the US Food and Drug Administration (FDA) approved brolucizumab-dbll (BEOVU®) for the treatment of neovascular age-related macular degeneration (nAMD). Brolucizumab is a humanized antibody single-chain variable fragment that binds to the 3 major isoforms of human vascular endothelial growth factor (VEGF), thereby interfering with their interaction with receptors VEGFR-1 and VEGFR-2 and suppressing endothelial cell proliferation, neovascularization and vascular permeability. BEOVU is administered by intravitreal injection, and the recommended dose is 6 mg monthly for the first three doses, followed by one dose of 6 mg every 8-12 weeks. A marketing application for brolucizumab is undergoing review by EMA.

FDA’s approval was based on data from two Phase 3 studies, HAWK (NCT02307682) and HARRIER (NCT02434328), comparing the efficacy and safety of intravitreal injections of brolucizumab versus aflibercept in nAMD. Brolucizumab met the primary efficacy endpoint of non-inferiority to aflibercept (EYLEA®) in mean change in best-corrected visual acuity (BCVA) at week 48 in both trials, with a mean change in BCVA of 6.6 letters for brolucizumab 6 mg versus 6.8 letters for aflibercept in HAWK trial and 6.9 letters versus 7.6 letters, respectively, in the HARRIER study. Additionally, at week 48, brolucizumab was superior to aflibercept in secondary endpoints considered key parameters of the disease, such as central subfield retinal thickness and retinal fluid (intraretinal fluid and/or subretinal fluid). Results at 96 weeks reaffirmed the superiority of brolucizumab 6 mg in reduction of retinal fluid, and patients who received this dose continued to demonstrate reductions in central subfield thickness.

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The Antibody Society maintains a comprehensive table of approved monoclonal antibody therapeutics and those in regulatory review in the EU or US. Located in the ‘Web Resources’ section of our website, the list is updated regularly and can be downloaded in Excel format.

New antibody-drug conjugate approved in the US

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On June 10, 2019, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Polivy (polatuzumab vedotin-piiq), in combination with the chemotherapy bendamustine and a rituximab product (BR), to treat adult patients with diffuse large B-cell lymphoma (DLBCL) that has progressed or returned after at least two prior therapies. Polivy is composed of a humanized anti-CD79b IgG1 antibody conjugated to the antimitotic agent monomethyl auristatin E (MMAE). The antibody’s target is highly expressed on B cells of patients with lymphoma. The biologics license application for Polivy was granted FDA’s Breakthrough Therapy and priority review designations. The drug also has European Medicines Agency (EMA)’s PRIME designation, and US and EU Orphan Drug designations for DLBCL. EMA is reviewing a marketing authorization application for Polivy.

The drug’s efficacy was evaluated in a study of 80 patients with relapsed or refractory DLBCL who were randomized to receive Polivy with BR or BR alone. Efficacy was based on complete response rate and duration of response (DOR), defined as the time the disease stays in remission. At the end of treatment, the complete response rate was 40% with Polivy plus BR compared to 18% with BR alone. Of the 25 patients who achieved a partial or complete response to Polivy plus BR, 16 (64%) had a DOR of at least six months and 12 (48%) had a DOR of at least 12 months.

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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. Located in the ‘Web Resources’ section of our website, the list is updated regularly 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’.

 

Anti-IL17 netakimab registered in Russia

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On May 7, 2019, BIOCAD announced the registration of netakimab (Efleira®, BCD-085) in Russia for the treatment of moderate to severe plaque psoriasis. Netakimab is a humanized IgG1 monoclonal antibody (mAb) in which the VH domain is replaced by a Lama glama VHH domain possessing a long complementarity-determining region (CDR-H3).  The mAb targets interleukin (IL)-17, a pro-inflammatory cytokine that plays a critical role in the pathogenesis of psoriasis. The registration is the first for an innovative mAb developed in Russia.

The efficacy and safety of Efleira® in psoriasis patients was confirmed in the Phase 3 BCD-085-7/PLANETA study (NCT03390101), which was conducted in 22 certified study sites in Russia and 2 study sites in the Republic of Belarus. After 12 weeks of the treatment, 83.3% of patients who received netakimab once a month after induction for the first 3 weeks achieved a 75% improvement in Psoriasis Area and Severity Index. The total duration of therapy and follow-up in this study is 3 years.

BIOCAD, which is based in Moscow, is planning to start a pivotal clinical trial of netakimab in psoriasis in Europe later in 2019.

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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’.