Benchmark – Approved Drug by the FDA Paper

Benchmark – Approved Drug by the FDA Paper

Benchmark – Approved Drug by the FDA Paper

Vyvgart is among the newly approved drugs by the FDA in the year 2021. The drug is used to treat myasthenia gravis and it is the first and the only neonatal FC receptor blocker approved by the FDA (Moise et al., 2022). Myasthenia gravis (MG) is a rare autoimmune disease that has low survival rates due to the inefficiencies in the current treatment options. The purpose of this paper is to discuss the drug in terms of pharmacodynamics and pharmacokinetics, indicated disease, potential risks, and compare it with the previously used treatments.

FDA-Approved Drug

Vygart is a human IgG1 that binds to the FcRn fragment and thus reduces the circulating immunoglobulin G. The drug was proved effective in a 26-week randomized double-blind placebo-controlled study involving a sample population of 167 gMG adult patients (Jordan & Freimer, 2018). The medication is administered intravenously; however, considering that it causes a transient reduction in the IgG levels, immunization is not recommended during the administration (Jordan & Freimer, 2018). As a result, the need to administer the age-appropriate immunization must be considered before administering the drug. The recommended dose administration for the vyvgart is 10mg/kg.

Other than the intravenous injection, the drug can also be given in I.V infusion for over 1 hour once a week for four weeks. In patients above 120kgs, the dose administration of 1200mg per infusion is recommended (Jordan & Freimer, 2018). The subsequent administrations should be based on the patient’s evaluation and assessment. Vygart reduces the circulating IgG which can affect the immune response to pathogens to some extent. Besides, patients are likely to have side effects such as respiratory tract infections, urinary tract infections, and headaches.

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Disease State for Which Drug Is Prescribed

Jordan and Freimer (2018) describe MG as an autoimmune disease that is characterized by fatigable muscle weakness and autoimmune response. The body produces antibodies against the acetylcholine receptors and the muscle-specific kinase among other protein molecules. Similarly, other antibodies such as the fast troponin and agrin are associated with the development of myasthenia gravis. The pathophysiology of the MG depends on the type of autoantibodies present. The antibodies bind to the receptors and degrade them, which could activate the complement pathway. The complement pathway affects various neuromuscular endplates. People with MG have their antibodies binding to the Ig-like region (Menon et al., 2020). In addition, the LRP4 is a transmembrane protein that binds the agrin to form a complex. The activation is critical in the neuromuscular junction activation and distribution of the acetylcholine receptors.


The MG is an antibody-mediated disease where the normal immune system autoreacts to the T cells and destroys the thymus through the central tolerance. The antigen-presenting cells submit the AChR to the CD4 cells and thus leading to the upregulation of the proinflammatory cytokines and the production of B cells. Commonly, IgG1 and IgG3 are produced during the immune response. The antibodies influence the pathogenic immune cascade by binding to the Fab fragment to the AChR (Menon et al., 2020). The understanding of the pathogenesis process leading to the formation of the Musk-LRP4 interactions is important in drug development.

Comparison of FDA Drug to Currently Available Therapies

MG has previously been treated using broad-spectrum immunotherapies, such as corticosteroids, mycophenolate, azathioprine, and tacrolimus among others. The effectiveness of these treatments has been limited. Besides, they are associated with serious long-term side effects that patients cannot tolerate. The advances in MG therapies have been guided by the need to develop effective and efficacious treatment options (Menon et al., 2020). As a result, future progress was directed on the direct therapeutic agents that could improve the treatment outcomes for people with MG. Some of the previously develop medications were classified as the terminal complement C5 inhibitors and the B cell-activating factor inhibitors among others (Vanoli & Mantegazza, 2022). T cell and cytokine-based therapies have been used previously to manage MG. Most of the treatment options predispose the patients to immunosuppression and this could expose them to opportunistic infections (Menon et al., 2020).

MG has also been treated using the plasma exchange and intravenous immunoglobulin methods. The mode of action for such approaches involves the activation or suppression of the target genes that eventually result in a multitude of changes including the reduction of the circulating T cells (Ndegwa& Mierzwinski-Urban, 2022). The treatment options are time-tested and have been used in managing MG; though, the side effects have been enormous.

Various studies have been conducted to develop the most appropriate treatment option for the MG. The FDA approved the vyvgart based on the results from the global phase 3 ADAPT trial. The study indicated that the anti-AChR antibodies positive gMG responded positively with Vyvgart compared to the placebo group (Fitzgerald, 2022). Vyvgart acts by binding specifically to the neonatal Fc receptor. The Fc receptor keeps the antibodies in the body for longer and therefore when the drug binds to the FcRn, the amount of the AChR antibodies is reduced in the body. Freimer (2018) also reported that vyvgart is well tolerated and efficacious in managing the general myasthenia gravis condition. The study reports that patients initiated on the medication had minimal symptom expression, reduced risk for admission, reduced cases of myasthenia crisis, and immunosuppressive effects.

Potential Risks, Monitoring, and Prescribing Likelihood

The purpose of a clinical trial is to determine the efficacy of a medication. A drug can only be approved when the benefits exceed the potential harm likely to be experienced by the patients. The clinical trial findings indicated that vyvgart has significant benefits to the patient compared to the previous medications used to manage myasthenia gravis (Jordan & Freimer, 2018). However, the patients are also likely to suffer significant side effects which must be monitored loosely. Patients on vyvgart have an increased risk for infection following the immunosuppression (Voelker, 2022). Therefore, the treatment should be delayed in patients with active infections until their conditions resolve. Besides, in case the patients get seriously ill, appropriate treatment should be initiated while withholding the Vyvgart until they recover. Secondly, patients should be monitored for potential hypersensitivity following the injection. According to Efgartigimod alfa-fcab (2022), the common infections witnessed among the patients receiving vyvgart included urinary tract infections and respiratory tract infections.

The studies conducted on the vyvgart provide adequate information about the therapeutic efficacy of the medication. The treatments for myasthenia gravis aim at reducing the immune response against the acetylcholine and so the antibodies produced in the body tend to reduce. Such reductions present a significant health risk to the patients as they become vulnerable to infections. The vyvgart is not an exception since it has a similar mode of action; though, the severity of the side effects is reduced. Considering that there is no better treatment option for the myasthenia gravis, I recommend the prescription of vyvgart. Close monitoring of the patient’s signs and symptoms is important in realizing the desired therapeutic outcome.

MG is a rare disease caused by the autoantibodies against the nicotinic acetylcholine and this affects the normal synaptic transmissions. The important safety considerations for the patients with myasthenia gravis include the extent of immunosuppressive effects following the reduction of the IgG levels in the body (Jordan & Freimer, 2018). However, in ensuring the safety of the patient, measures to achieve the desired therapeutic concentration must be observed. Myasthenia gravis affects the muscles functioning and this could lead to atrophy.


Myasthenia gravis is one of the rare autoimmune diseases that limit the ability of the muscles to transmit electrical impulses. Vyvgart is the latest medication approved for treating the disease. The medication is effective since it blocks the effects of IgG on nicotine acetylcholine. Though, the treatment could result in immunosuppression which is a critical factor to monitor among the patients using the drug.


Efgartigimod alfa-fcab. (2022). American Journal of Health-System Pharmacy

Fitzgerald, S. (2022). Expanding treatment options for myasthenia gravis. Neurology Today22(2), 8-10.

Freimer, M. (2018). Faculty opinions recommendation of safety and efficacy of eculizumab in anti-acetylcholine receptor antibody-positive refractory generalized myasthenia gravis (REGAIN): A phase 3, randomized, double-blind, placebo-controlled, multicentre study. Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature

Howard, J. F. (2018). Toxic neuromuscular transmission disorders. Myasthenia Gravis and Related Disorders, 275-298.

Jordan, A., & Freimer, M. (2018). Recent advances in understanding and managing myasthenia gravis. F1000Research7, 1727.

Menon, D., Barnett, C., & Bril, V. (2020). Novel treatments in myasthenia gravis. Frontiers in Neurology11

Moise, K. J., Oepkes, D., Lopriore, E., & Bredius, R. G. (2022). Targeting neonatal Fc receptor: Potential clinical applications in pregnancy. Ultrasound in Obstetrics & Gynecology

Ndegwa, S., & Mierzwinski-Urban, M. (2022). Emerging drugs for generalized myasthenia gravis. Canadian Journal of Health Technologies2(2).

Vanoli, F., & Mantegazza, R. (2022). Antibody therapies in autoimmune neuromuscular Junction disorders: Approach to myasthenic crisis and chronic management. Neurotherapeutics

Voelker, R. (2022). A new option is approved for patients with myasthenia gravis. JAMA327(5), 417.


Assessment Description
Choose a drug that has been approved by the FDA within the past year.

Write a 1,000-1,250 word paper in which you:

Describe the drug approved by the FDA. Include the pharmacodynamics and pharmacokinetic properties of the chosen drug.
Provide an overview of the disease state for which the drug is used.
Describe what is different about this agent compared to currently available therapies.
Discuss the potential risks associated with this agent and any monitoring parameters that are necessary.
Decide whether you would personally prescribe this agent or stick with currently available alternatives.
You are required to cite 5-10 sources to complete this assignment. Sources must be published within the last 5 years and appropriate for the assignment criteria and nursing content.

Prepare this assignment according to the guidelines found in the APA Style Guide, located in the Student Success Center.

This assignment uses a rubric. Review the rubric prior to beginning the assignment to become familiar with the expectations for successful completion.

You are required to submit this assignment to LopesWrite. A link to the LopesWrite technical support articles is located in Class Resources if you need assistance.

Benchmark Information

This benchmark assignment assesses the following programmatic competencies:


6.3: Assess the pharmacodynamics and the pharmacokinetic impact of pharmacologic therapies in the treatment of diseases and altered states.


Benchmark – Approved Drug by the FDA – Rubric

Expand All Benchmark – Approved Drug By The FDA – RubricExpand All

FDA-Approved Drug

24 points

Disease State for Which Drug Is Prescribed

24 points

Comparison of FDA Drug to Currently Available Therapies

18 points

Potential Risks, Monitoring, and Prescribing Likelihood (B)

12 points

Required Sources

6 points

Thesis Development and Purpose

8.4 points

Argument Logic and Construction

9.6 points

Mechanics of Writing (includes spelling, punctuation, grammar, language use

6 points

Paper Format (Use of appropriate style for the major and assignment)

6 points

Documentation of Sources

6 points

Total 120 points


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