The Antibody Society

the official website of the antibody society

The Antibody Society

An international non-profit supporting antibody-related research and development.

You are here: Home / Archives for approved antibodies

New antibody-drug conjugate approved in the US

by

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.

Like this post but not a member? Please join!

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

by

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.

Like this post but not a member? Please join!

Risankizumab-rzaa granted FDA approval

by

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.

Like this post but not a member? Please join!

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

by

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.

Like this post but not a member? Please join!

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

by

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.

Like this post but not a member? Please join!

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’.