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FDA approves brodalumab

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On February 15, 2017, the US Food and Drug Administration approved brodalumab (Siliq; Valent Pharmaceuticals International, Inc.) to treat adults with moderate-to-severe plaque psoriasis. Brodalumab, an IgG2 monoclonal antibody targeting the interleukin (IL)-17 receptor, inhibits the biological activity of IL-17A, IL-17F and other IL-17s. Labeling for brodalumab includes a Black Box Warning for the risks of suicidal thoughts or behavior. The product was approved with a Risk Evaluation and Mitigation Strategy (REMS) that includes prescriber and pharmacy certifications and informed consent by patients.

Brodalumab was granted its first marketing approval from the Ministry of Health, Labour and Welfare in Japan on July 4, 2016 for the treatment of psoriasis vulgaris, psoriatic arthritis, pustular psoriasis, and psoriatic erythroderma. The product’s brand name in Japan is Lumicef®. A marketing authorization application for brodalumab in psoriasis is undergoing evaluation by the European Medicines Agency.

The Antibody Society maintains a comprehensive table of approved antibody therapeutics and those in regulatory review in the EU or US. As of February 16, 2017, marketing applications for a total of 12 antibody therapeutics that have not been approved in any country are undergoing review in the EU or US. In addition, marketing applications for sarilumab, which is approved in Canada, and gemtuzumab ozogamicin, which was FDA approved in 2000 and subsequently withdrawn from the US market, are undergoing review in the EU and US.

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First approval for sarilumab

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On January 12, 2017, Health Canada approved sarilumab (Kevzara) for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more biologic or non-biologic disease-modifying anti-rheumatic drugs. This is the first approval in any country for sarilumab, which is a human IgG1 that binds to soluble and membrane-bound forms of the interleukin-6 receptor. Marketing applications for sarilumab were submitted to the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Ministry of Health, Labour and Welfare in Japan. The marketing applications for sarilumab are based on results from Phase 3 trials in the SARIL-RA clinical development program, which includes ~ 2,900 adults with moderately to severely active RA who had an inadequate response or intolerance to previous treatment regimens. FDA issued a complete response letter in October 2016; resubmission of the application to FDA is expected in the first quarter of 2017, and an action by FDA is expected in the second quarter of 2017. An opinion regarding the marketing application submitted to EMA is expected in 2017.

The annual number of first approvals for new antibody therapeutics is expected to reach a record in 2017.  Sarilumab’s approval is the first of at least 12 first approvals for new antibody therapeutics expected in 2017. The Antibody Society will post reports on the progress of mAb therapeutics during 2017, with an emphasis on first marketing application submissions and approvals in the European Union, United States and Japan. The 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, located in the Members Only section.

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mAb first approvals in 2017 may set a new record

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A new record for the number of monoclonal antibody (mAb) therapeutics granted their first marketing approval during a single year may be set in 2017. The previous record was set in 2015, when 8 antibody therapeutics were granted first approvals. Remarkably, 11 investigational mAb therapeutics are currently being considered for first marketing approvals that may be granted in 2017. Of these, 4 mAbs are under review as treatments for common immune-mediated disorders such as dermatitis, psoriasis and rheumatoid arthritis (anti-IL-6 sirukumab, anti-IL-6R sarilumab, anti-IL-4Ra dupilumab and anti- IL-23p19 guselkumab), 4 mAbs are under review as treatments for various types of cancer (anti-IL-1 alpha Xilonix, anti-CD22 inotuzumab ozogamicin, anti-PD-L1 avelumab and anti-PD-L1 durvalumab) and 3 mAbs are under review as treatments for other disorders (anti-CD20 ocrelizumab for multiple sclerosis, anti-sclerostin romosozumab for osteoporosis and anti-FGF23 burosumab for X-linked hypophosphatemia). Marketing applications for additional mAb therapeutics may be submitted to regulatory agencies during the first half of 2017, which could allow additional first approvals to occur during 2017.

Additional information on antibody therapeutics in Phase 3 clinical studies, regulatory review and those recently approved can be found in the ‘Antibodies to watch in 2017’ article, which can be freely downloaded.

The Antibody Society will post reports on the progress of mAb therapeutics during 2017, with an emphasis on first marketing application submissions and approvals in the European Union, United States and Japan. The 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, located in the Members Only section.

Not a member? Please join!

Membership is free for employees of the Society’s corporate sponsors.

Guselkumab license application submitted to FDA

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mabs2013-600-268Janssen has submitted a biologics license application (BLA) for guselkumab (CNTO 1959), an IgG1 monoclonal antibody that targets the IL-23 p19 subunit, to the US Food and Drug Administration. The BLA includes data from four studies, the VOYAGE 1, VOYAGE 2 and NAVIGATE Phase 3 studies and the X-PLORE Phase 2 study, evaluating the efficacy and safety of guselkumab administered by subcutaneous (SC) injection in the treatment of adults with moderate to severe plaque psoriasis. VOYAGE1 and 2 (NCT02207231 and NCT02207244) and NAVIGATE (NCT02203032) had primary completion dates in 2015. The VOYAGE1 and 2 studies assessed the effects of 100 mg SC doses of guselkumab vs Humira® (adalimumab) or placebo in patients with moderate to severe plaque psoriasis. Results of the VOYAGE1 study were presented at the 25th European Academy of Dermatology and Venereology Congress held in September 2016. At week 16, significantly higher proportions of patients receiving guselkumab achieved an Investigator’s Global Assessment score of cleared or minimal disease and at least a 90 percent improvement in the Psoriasis Area Severity Index (85.1% and 73.3%, respectively) compared with those taking Humira® (65.9% and 49.7%, respectively). The values for these endpoints were also significantly higher in patients who received guselkumab vs placebo. Janssen has indicated that additional findings from VOYAGE 1, as well as the VOYAGE 2 and NAVIGATE study, which evaluated the efficacy and safety of guselkumab for the treatment of subjects with moderate to severe plaque-type psoriasis and an inadequate response to ustekinumab, will be released at future scientific congresses. A Phase 3 study (NCT02343744) of guselkumab that is currently recruiting patients with generalized pustular psoriasis or erythrodermic psoriasis has an estimated primary completion date of January 2017, and two additional Phase 3 studies of guselkumab in psoriasis patients that have estimated primary completion dates later in 2017 (NCT02905331, NCT02951533) are not yet recruiting patients.

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

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Membership is free for employees of the Society’s corporate sponsors.

First approval for bezlotoxumab, a new antibody therapeutic for reduction of C. difficile infection recurrance

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Antibody impressionBezlotoxumab (ZINPLAVA) was approved by the US Food and Drug Administration to reduce recurrence of Clostridium difficile infection (CDI) in adult patients (18 years of age or older) who are receiving antibacterial drug treatment of CDI and are at high risk for CDI recurrence. The product is a human IgG1 monoclonal antibody that targets C. difficile toxin B, and it is the first monoclonal antibody therapeutic to be approved for reduction of recurrence of a bacterial infection. Bezlotoxumab was developed by researchers at the University of Massachusetts Medical School’s MassBiologics Laboratory in conjunction with Medarex (now part of Bristol-Myers Squibb), and was licensed to Merck in 2009.

Bezlotoxumab is the 6th new antibody therapeutic to be granted a first approval in 2016. Of the applications for 8 new mAb therapeutics currently undergoing regulatory review in the US or EU (i.e., mAbs not previously approved for any indication in these regions), 3 have FDA action dates known to occur in late October-December 2016. The Antibody Society maintains a comprehensive table of approved antibody therapeutics and those in regulatory review in the US or EU. Please log in to access the table, located in the Members Only section.

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