Persons with disabilities having problems accessing the pdf files below may call 301 7963634 for assistance. Gsk files with fda and ema for mepolizumab in asthma. Subcutaneous lyophilized power, prescription, none, no, no. Gsk submits us regulatory application for mepolizumab in. Guidance for the content of premarket submissions for software contained in medical devices guidance for industry and fda staff may 2005. After reconstitution, each ml of solution contains 100 mg mepolizumab. Nucala mepolizumab for injection nucala mepolizumab injection. 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.
Action date, submission, action type, submission classification. Mepolizumab nucala for severe eosinophilic asthma the. Nucala mepolizumab gains fda approval for two new self. Nucala mepolizumab dosing, indications, interactions. 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. Data sources include ibm watson micromedex updated 10 apr 2020, cerner multum updated 6 apr 2020, wolters kluwer updated. However, mepolizumab is a humanized monoclonal antibody igg1 kappa, and immunoglobulin g igg is present in human milk in. Us regulatory application for mepolizumab in copd company. 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. The fda has approved mepolizumab nucala gsk, a subcutaneously injected humanized interleukin5 il5 antagonist monoclonal antibody, for maintenance treatment of severe asthma in patients. Copd and severe asthma programs were specifically designed to target each.
Glaxosmithkline, a humanized, interleukin5 il5 antagonist monoclonal antibody, was approved by the us food and drug administration fda as an addon subcutaneous maintenance treatment for patients aged. 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. Nucala 100 mg powder for solution for injection summary of. Mepolizumab approved for maintenance treatment in severe asthma. Drugdrug interaction potential for mepolizumab is low considering its proteolytic elimination pathway and also because il. Highlights of prescribing information warnings and precautions these highlights do not include all the information needed to use nucala safely and effectively. Three mepolizumab drug product dp presentations have been used.
At the 1 august 2017 prebla submission meeting, fda agreed that the clinical data. Nov 09, 2018 mepolizumab is a monoclonal antibody that affects the actions of the bodys immune system. Gsk achieves approval for nucala mepolizumab for the. Fda approves mepolizumab for churgstrauss egpa rheumnow. Regulatory filings in other countries are planned during the course of 2017 and 2018. 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. 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. 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. The vial stopper is not made with natural rubber latex. Study of mepolizumab autoinjector in asthmatics full text. Jun 14, 2019 mepolizumab is not a rescue medicine for asthma attacks. Mepolizumab has a molecular weight of 149 kdaltons, precluding elimination by glomerular filtration.
Mepolizumab side effects, dosage, interactions drugs. Nucala mepolizumab gains fda approval for two new selfadministration options read this article along with other careers information. Gsk today announced the submission of a supplemental biologics license application sbla to the united states food and drug administration fda, seeking approval. It was approved by the fda in november 2015 for the treatment of severe asthmatics aged 12 years and older with an eosinophilic phenotype. Content of premarket submissions for software contained in. Jan 25, 2017 evidencebased recommendations on mepolizumab nucala for treating severe refractory eosinophilic asthma in adults. Mepolizumab for treating severe refractory eosinophilic asthma.
Jul 19, 2016 mepolizumab is a humanized monoclonal antibody. Fda briefing document pulmonaryallergy drugs advisory. Common adverse reactions include headache, injection site reaction, back pain, and fatigue 5%. If youre a patient at msk and you need to reach a provider after 5. Us regulatory submission for mepolizumab as egpa treatment 29062017 print. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Nucala in support of mepolizumab, a firstinclass, antiinterleukin 5 monoclonal antibody antiil5, as a treatment for severe asthma. Each vial of nucala should be used for a single patient, and any remainder of the contents. This drug crossed the placental barrier in animal models and is predicted to have its greatest effect during the second and third trimesters. Mepolizumab for eosinophilic chronic obstructive pulmonary.
Efficacy and safety study of mepolizumab in subjects with. 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. 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. Mepolizumab is not approved anywhere in the world for copd. An fda panel recommended against mepolizumab as addon treatment to inhaled corticosteroidbased maintenance treatment in patients with copd guided by blood eosinophil counts. Mepolizumab pregnancy warnings animal studies have failed to reveal evidence of fetal harm in doses up to 30 times the maximum recommended human dose. Gsk achieves approval for nucala mepolizumab for the treatment of eosinophilic granulomatosis with polyangiitis egpa for adults in the us. Article fda calls for more data before approving nucala sbla. Use only fastacting inhalation medicine for an attack. Mepolizumab works by reducing levels of a certain type of white blood cell that may contribute to the. Seek medical attention if your breathing problems get worse quickly, or if you think your asthma medications are not working as well. Mepolizumab works by reducing levels of a certain type. Nucala mepolizumab lyophilized powder for subcutaneous. Gsk announces us regulatory submission for mepolizumab in.
The search was limited to studies performed in humans and published in the english language. The positive but sometimes conflicting results from antiil5 clinical trials make even more evident the need for careful phenotyping and endotyping of patients. Evidence for the efficacy of mepolizumab was established in a nejm report n engl j med 2017. Often with novel development programs, there are more. Us regulatory submission for mepolizumab as egpa treatment. 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. This is first fda approved therapy specifically to treat egpa. Food and drug administration fda and european medicines agency ema for mepolizumab as maintenance treatment for severe eosinophilic asthma. 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. Listing a study does not mean it has been evaluated by the u. Orphan drug designation provides incentives to assist and encourage the development of drugs for rare diseases. Mepolizumab is a humanised monoclonal antibody produced in chinese hamster ovary cells by recombinant dna technology.
The clinical development program of this submission includes two phase 1 studies in. 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. The effect of sex, age, race, and body weight on the pk of mepolizumab was assessed using the population approach, in which study mea115588 was included for the population pk analysis. Nov 07, 2017 the submission includes phase iii data from the previously reported 1,2 metrex and metreo studies. Nucala, an interleukin il5 antagonist monoclonal antibody igg1. Simply select your manager software from the list below and click on download. If you have any questions, contact a member of your healthcare team directly. Subcutaneous mepolizumab in children aged 6 to 11 years. 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. Dailymed nucala mepolizumab injection, powder, for. Mepolizumab crossed the placenta in cynomolgus monkeys.
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 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. 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. Nucala mepolizumab for injection, for subcutaneous use initial u. Epga, formerly known as churgstrauss syndrome, causes vasculitis, an inflammation in the wall of blood vessels of the body.
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