Gsk today announced the submission of a supplemental biologics license application sbla to the united states food and drug administration fda, seeking approval. Mepolizumab for eosinophilic chronic obstructive pulmonary. Gsk today announced the submission of a supplemental biologics license application sbla to the united states food and drug administration fda, seeking approval of mepolizumab, an interleukin5 il5 antagonist, as an addon to maintenance treatment for patients who have chronic obstructive pulmonary disease copd with an eosinophilic phenotype. Subcutaneous lyophilized power, prescription, none, no, no. Fda briefing document pulmonaryallergy drugs advisory. Article fda calls for more data before approving nucala sbla. Nucala mepolizumab dosing, indications, interactions. Data sources include ibm watson micromedex updated 10 apr 2020, cerner multum updated 6 apr 2020, wolters kluwer updated. Food and drug administration fda for the maintenance treatment of severe asthma in patients aged 6 years or older and with an eosinophilic phenotype in combination with other medicines used to treat asthma. Mepolizumab for treating severe refractory eosinophilic asthma.
Mepolizumab works by reducing levels of a certain type of white blood cell that may contribute to the. Listing a study does not mean it has been evaluated by the u. Use only fastacting inhalation medicine for an attack. Study of mepolizumab autoinjector in asthmatics full text. Mepolizumab has a molecular weight of 149 kdaltons, precluding elimination by glomerular filtration. Nov 04, 2015 the fda has approved mepolizumab nucala, glaxosmithkline in combination with other asthma medications for maintenance treatment of patients aged 12 years or older with severe asthma. Mepolizumab approved for maintenance treatment in severe asthma.
Common adverse reactions include headache, injection site reaction, back pain, and fatigue 5%. Nucala, an interleukin il5 antagonist monoclonal antibody igg1. If youre a patient at msk and you need to reach a provider after 5. The fda has approved mepolizumab nucala gsk, a subcutaneously injected humanized interleukin5 il5 antagonist monoclonal antibody, for maintenance treatment of severe asthma in patients. Gsk today announced the submission of a supplemental biologics license application sbla to the united states food and drug administration fda, seeking approval of mepolizumab, an interleukin5 il5 antagonist, as an addon therapy to corticosteroids for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis egpa. Each vial of nucala should be used for a single patient, and any remainder of the contents. Mepolizumab for severe refractory eosinophilic asthma. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Gsk announces us regulatory submission for mepolizumab in. The food and drug administration fda approved use of nucala mepolizumab for use in treating adults with eosinophilic granulomatosis with polyangiitis egpa, previously known as churgstrauss vasculitis.
Nucala 100 mg powder for solution for injection summary of. Jul 26, 2018 an fda panel recommended against mepolizumab as addon treatment to inhaled corticosteroidbased maintenance treatment in patients with copd guided by blood eosinophil counts. Fda approves mepolizumab for churgstrauss egpa rheumnow. Guidance for the content of premarket submissions for software contained in medical devices guidance for industry and fda staff may 2005. Nov 12, 2019 nucala mepolizumab for injection is a sterile, preservativefree, white to offwhite, lyophilized powder for reconstitution and sc injection in a singledose glass vial with a flipoff seal. The positive but sometimes conflicting results from antiil5 clinical trials make even more evident the need for careful phenotyping and endotyping of patients.
In conditions where eosinophilia is considered to play an important part in the pathology, including eosinophilic asthma, hes, and eosinophilic granulomatosis with polyangiitis, a consistent reduction in blood eosinophil counts is observed in association with mepolizumab administration, with concomitant clinical improvement. Regulatory filings in other countries are planned during the course of 2017 and 2018. Gsk submits us regulatory application for mepolizumab in. Content of premarket submissions for software contained in. Nov 09, 2018 mepolizumab is a monoclonal antibody that affects the actions of the bodys immune system. The fdas esubmitter software is part of an electronic submissionsprocess that is available for voluntary use by sponsors, manufacturers, and importers to create a variety of submission types. After reconstitution, each ml of solution contains 100 mg mepolizumab. Copd and severe asthma programs were specifically designed to target each. Mepolizumab is an interleukin5 antagonist monoclonal antibody igg1 kappa that is fda approved for the treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype indicated for addon maintenance treatment. Gsk achieves approval for nucala mepolizumab for the treatment of eosinophilic granulomatosis with polyangiitis egpa for adults in the us. Orphan drug designation provides incentives to assist and encourage the development of drugs for rare diseases. Us regulatory submission for mepolizumab as egpa treatment.
Gsk achieves approval for nucala mepolizumab for the. Us regulatory submission for mepolizumab as egpa treatment 29062017 print. This drug crossed the placental barrier in animal models and is predicted to have its greatest effect during the second and third trimesters. An fda panel recommended against mepolizumab as addon treatment to inhaled corticosteroidbased maintenance treatment in patients with copd guided by blood eosinophil counts. Nucala mepolizumab lyophilized powder for subcutaneous. Gsk files with fda and ema for mepolizumab in asthma. Apr 04, 2017 study of mepolizumab autoinjector in asthmatics the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Often with novel development programs, there are more. The submission to the fda is the first to a regulatory authority for mepolizumab for copd. However, mepolizumab is a humanized monoclonal antibody igg1 kappa, and immunoglobulin g igg is present in human milk in. Nucala mepolizumab for injection, for subcutaneous use initial u. For these reasons no specific hepatic or renal impairment studies were necessary.
Nucala mepolizumab gains fda approval for two new self. Fda approval history for nucala mepolizumab used to treat asthma, eosinophilic granulomatosis with polyangiitis. Aug 11, 2016 after the fda approval of mepolizumab a new option is available for the treatment of severe asthma, after a decade of omalizumab as the only biologic agent. Epga, formerly known as churgstrauss syndrome, causes vasculitis, an inflammation in the wall of blood vessels of the body. Mepolizumab is a humanised monoclonal antibody produced in chinese hamster ovary cells by recombinant dna technology. Mepolizumab nucala for severe eosinophilic asthma the. Highlights of prescribing information warnings and precautions these highlights do not include all the information needed to use nucala safely and effectively. Mepolizumab pregnancy warnings animal studies have failed to reveal evidence of fetal harm in doses up to 30 times the maximum recommended human dose. If you have any questions, contact a member of your healthcare team directly. This is first fda approved therapy specifically to treat egpa. Seek medical attention if your breathing problems get worse quickly, or if you think your asthma medications are not working as well.
Drugdrug interaction potential for mepolizumab is low considering its proteolytic elimination pathway and also because il. Sep 12, 2019 nucala mepolizumab injection, powder, for solution nucala mepolizumab injection, solution if this spl contains inactivated ndcs listed by the fda initiated compliance action, they will be specified as such. The vial stopper is not made with natural rubber latex. Mepolizumab crossed the placenta in cynomolgus monkeys. Mepolizumab works by reducing levels of a certain type.
Evidence for the efficacy of mepolizumab was established in a nejm report n engl j med 2017. The clinical development program of this submission includes two phase 1 studies in. It was approved by the fda in november 2015 for the treatment of severe asthmatics aged 12 years and older with an eosinophilic phenotype. Mepolizumab is a monoclonal antibody that affects the actions of the bodys immune system. Backgroundpatients with chronic obstructive pulmonary disease copd with an eosinophilic phenotype may benefit from treatment with mepolizumab, a monoclonal antibody directed against interleukin5. Us regulatory application for mepolizumab in copd company. Dec 12, 2017 the us food and drug administration fda has approved mepolizumab nucala as the first drug specifically for adults with rare autoimmune disease eosinophilic granulomatosis with polyangiitis egpa. Action date, submission, action type, submission classification. Nucala in support of mepolizumab, a firstinclass, antiinterleukin 5 monoclonal antibody antiil5, as a treatment for severe asthma. Nucala mepolizumab for injection nucala mepolizumab injection. Mepolizumab side effects, dosage, interactions drugs.
If you have the appropriate software installed, you can download article citation data to the citation manager of your choice. Simply select your manager software from the list below and click on download. Subcutaneous mepolizumab in children aged 6 to 11 years. The search was limited to studies performed in humans and published in the english language. The fda has approved mepolizumab nucala, glaxosmithkline in combination with other asthma medications for maintenance treatment of patients aged 12 years or older with severe asthma. Nucala mepolizumab gains fda approval for two new selfadministration options read this article along with other careers information. Jan 25, 2017 evidencebased recommendations on mepolizumab nucala for treating severe refractory eosinophilic asthma in adults. Jun 14, 2019 mepolizumab is not a rescue medicine for asthma attacks. Three mepolizumab drug product dp presentations have been used. The submission includes phase iii data from the previously reported 1,2 metrex and metreo studies. At the 1 august 2017 prebla submission meeting, fda agreed that the clinical data. Jul 19, 2016 mepolizumab is a humanized monoclonal antibody. Nov 07, 2017 the submission includes phase iii data from the previously reported 1,2 metrex and metreo studies. Mepolizumab is not approved anywhere in the world for copd.
Dailymed nucala mepolizumab injection, powder, for. Efficacy and safety study of mepolizumab in subjects with. The safety of mepolizumab has been studied in three randomized, placebocontrolled, multicentre clinical trials of 24 to 52 weeks duration and three openlabel, uncontrolled, extension studies with a median treatment duration of 2. Mepolizumab injection is used along with other medications to prevent wheezing, difficulty breathing, chest tightness, and coughing caused by asthma in certain children 6 years of age and older and adults whose asthma is not controlled with their current asthma medications. Gsk files with fda and ema for mepolizumab in asthma by estel grace masangkay glaxosmithkline announced that it has filed regulatory applications with the u. Food and drug administration fda and european medicines agency ema for mepolizumab as maintenance treatment for severe eosinophilic asthma.
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