Overview of a Recently Approved Drug by the U.S. Food & Drug Administration The exhaustive and lengthy approval process used by the U.S. Food & Drug Administration (FDA) means that when new drugs are released, they are considered sufficiently safe for use by humans as directed by physicians. This approval process, though, also means that just a relatively few new drugs are approved each year, including Kevzara used to treat adult rheumatoid arthritis approved for release on May 22, 2017 (Novel drug approvals, 2017). Given the rapid increase in the elderly demographic in the U.S. in recent years that is projected to continue well into the 21st century (Poterba, 2016), novel treatments for adult rheumatoid arthritis represent important and timely advances in drug therapy. This paper provides a description of Kevazara, including its pharmacodynamics and pharmacokinetic properties as well as an overview of the rheumatoid arthritis disease state for which it is used. In addition, a description concerning what is different about this drug compared to other currently available therapies is followed by a discussion concerning the potential risks associated with this agent and any monitoring parameters that are necessary. Finally, an analysis concerning whether this author would personally prescribe Kevazara or rely on currently available alternatives is followed by a summary of the research and important findings concerning Kevazara in the conclusion.

Description of Kevazara and its pharmacodynamics and pharmacokinetic properties

The newly approved Kevzara was developed for the treatment of adults who suffer from moderate to severe active rheumatoid arthritis following the prescription of at least one other disease-modifying anti-rheumatic drugs which was either not tolerated or failed to produce...

This drug is comprised of an interleukin-6 (IL-6) receptor antagonist (Highlights of prescribing information, 2017). A growing of research indicates that the IL-6 receptor antagonist in particular represents an efficacious intervention for rheumatoid arthritis that cannot be well managed otherwise (Hennigan & Kavanaugh, 2008). In this regard, Hennigan and Kavanaugh (2008) report that, “Efficacy achieved with certain agents [such as] IL-6, a cytokine with effects on numerous cell types, including those involved in the pathogenesis of rheumatoid arthritis” (p. 767).
Overview of the rheumatoid arthritis disease state for which the drug is used

Rheumatoid arthritis is an inflammatory autoimmune disease that causes stiffness, swelling and pain in any of the human joints (typically more than one joint), and if one limb develops the disease, it is probable that the other will as well (Overview of rheumatoid arthritis, 2017). The disease also fatigues sufferers who may also develop fevers but its effects tend to vary in intensity over time in some individuals while others experience a more severe form that can persist for a number of years or even for a entire lifetime (Overview of rheumatoid arthritis, 2017). In fact, the more severe forms of rheumatoid arthritis can result in severe damage to the joints it affects (Overview of rheumatoid arthritis, 2017).

Although the incidence of rheumatoid arthritis, or the number of new cases that are identified each year, has been declining in recent years, there has been a corresponding trends towards onset of the disease at older ages as well (Harris, 2009). At present, the prevalence, or the number of people who actually have rheumatoid arthritis today, is approximately 0.6%…