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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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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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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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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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First approval for olaratumab, a new antibody therapeutic for sarcoma

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Antibody impressionOlaratumab (Lartruvo®) was granted an accelerated approval for treatment, with doxorubicin, of adults with soft tissue sarcoma by the US Food and Drug Administration on October 19, 2016. This new monoclonal antibody (mAb) therapeutic targets platelet-derived growth factor receptor-α. The approval was granted in part based on results of a clinical study that compared administration of doxorubicin alone with the combination of olaratumab with doxorubicin. In this study, median overall survival was 14.7 vs. 26.5 months for patients who received doxorubicin alone vs. those who received the combination of drugs. Olaratuzumab’s application was granted numerous FDA designations intended to facilitate the development of new drugs, especially those for serious or life-threatening diseases, including Fast Track and Breakthrough Therapy designations, and priority review. The product also received orphan drug designations in both the US and European Union (EU). On September 15, 2016, the European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the granting of a conditional marketing authorization for olaratumab for the treatment of advanced soft tissue sarcoma. A decision by the European Commission is pending.

Olaratumab is the 5th new antibody therapeutic to be granted a first approval in 2016. Of the applications for 9 new mAb therapeutics currently undergoing regulatory review in the US or EU (i.e., mAbs not previously approved for any indication in these regions), 4 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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