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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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New guidance available from FDA on nonproprietary naming of biological products

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The US Food and Drug Administration (FDA) has released new guidance for industry on nonproprietary naming of biological products licensed under the Public Health Service (PHS) Act. The guidance describes FDA’s current thinking on the need for nonproprietary names that include a core name and an FDA-designated suffix. Such ‘proper names’, which are the nonproprietary names designated by FDA in the license for a biological product licensed under the PHS Act, will include a distinguishing suffix that is composed of 4 lowercase letters devoid of meaning attached to a core name with a hyphen. For example, replicamab-cznm and replicamab-hjxf represent proper names for two products sharing one core name (replicamab). The FDA intends to use the adopted name designated by the US Adopted Name (USAN) Council as the core name for the relevant biological when available. FDA’s current thinking is that proper names including the suffix are warranted for originator biological products, related biological products and biosimilar products to facilitate pharmacovigilance and accurate identification by health care practitioners and patients, and to help minimize inadvertent substitution of products not determined to be interchangeable. Prospective naming, retrospective naming and naming of biosimilar products are discussed in the guidance. For prospective naming and naming of biosimilar products, the applicants should propose a suffix; in the case of retrospective naming of licensed products, the biological license application holders may propose a suffix.

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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.

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

Antibody therapeutics for immune-mediated disorders

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Antibody impressionPatients’ choice in antibody therapeutics for common immune-mediated disorders such as psoriasis and rheumatoid arthritis (RA) is set to substantially increase in 2017. As of December 1, 2016, marketing applications for 10 antibody therapeutics are being evaluated by either the US Food and Drug Administration (FDA) or European Medicines Agency (EMA) for possible first approvals in the US or EU, respectively. Of these, five (brodalumab, dupilumab, sirukumab, sarilumab, and guselkumab) are being considered as treatments for immune-mediated disorders.

Brodalumab (LUMICEF®) is a human anti-IL-17 receptor A mAb that inhibits biological activity of IL-17A, IL-17F and other IL-17s. The product was granted a 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 FDA’s action date for the biologics license application (BLA) is February 16, 2017. A marketing authorization application for brodalumab in psoriasis is undergoing evaluation by EMA. Guselkumab, an IgG1 mAb that targets the IL-23 p19 subunit, is undergoing review by FDA and EMA as a treatment for plaque psoriasis. Dupilumab (Dupixent®), an anti-IL-4Ra IgG4 mAb, is undergoing review by FDA for atopic dermatitis. The mAb has Breakthrough Therapy designation for this indication, and the BLA was granted a priority review. FDA’s action date for the application is March 29, 2017. Sirukumab is a human anti-IL-6 mAb being evaluated by EMA, FDA and the Ministry of Health, Labour and Welfare for the treatment of adult patients with moderately to severely active RA. Sarilumab, a human IgG1 targeting IL-6R, is undergoing review by EMA, FDA and the Ministry of Health, Labour and Welfare in Japan for the treatment of adult patients with moderately to severely active RA. The BLA submitted to FDA has undergone a first review; deficiencies identified were detailed in a complete response letter.

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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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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