For health care providers, staying up to date on drug development trends is crucial to understanding the implications of these therapies and how they can best help their patients.
Each year, drug approvals and novel therapies hit the market and offer patients new treatment options. For health care providers, staying up to date on drug development trends is crucial to understanding the implications of these therapies and how they can best help patients.
In a session held at the ASHP 2018 Summer Meeting and Exhibition in Denver, Colorado, Tom Frank, PharmD, BCPS, and owner of Frank Medical Consulting in Jonesboro, Arkansas, highlighted some of the key new drugs in primary care for 2018 that providers should know about.
1. Zoster vaccine recombinant (Shingrix, GlaxoSmithKline)
Zoster vaccine recombinant (ZVR) is indicated for the prevention of herpes zoster in adults 50 and older. Unlike Zostavax, Shingrix is an inactive recombinant vaccine.
There are 1 million new shingles cases in the United States each year, and about 10% to 15% of those who get shingles will experience post-herpetic neuralgia as a result, according to Frank.
The antigen is recombinant varicella zoster virus glycoprotein E, and the adjuvant used in reconstitution is ASO1B. ZVR triggers immune responses specifically against VZV glycoprotein E, which is essential to viral replication and cell-to-cell spread.
ZVR should be administered in 2 doses, with the second being administered 2 to 6 months after the first. It is recommended even if the patient previously received Zostavax (separate by at least 8 weeks) and regardless of chicken pox or shingles history.
Frank also emphasized the differences between storage for Shingrix and Zostavax, noting that providers should be mindful of potential medication errors that can occur early in the stream. Unlike Zostavax, which should be stored in the freezer, Shingrix must be stored in the refrigerator.
2. Meropenem and vaborbactam (Vabomere)
Vabomere is a combination antibiotic indicated to treat complicated urinary tract infections, including pyelonephritis.
Driven by the need for alternative antibiotic treatments to fight resistant diseases, the product went from concept to development in just 8 years, Frank said during the presentation.
In clinical trials, the clinical cure rate for meropenem/vabobactam was 64% compared with 33% for the other best available therapy.
"This is not going to be a first out-of-the-starting-gate antibiotic," Frank said, indicating that the drug will be used to treat patients who have already developed a resistance and need an alternative option.
Meropenem, a carbapenem antibiotic, inhibit cell wall synthesis of susceptible bacteria by attaching to PBP target sites. Vaborbactam, a non-suicidal beta lactamases, protects meropenem from degradation by certain serine beta lactamases, such as Klebsiella pneumoniae carbapenemase.
3. Semaglutide (Ozempic, Novo Nordisk)
Novo Nordisk’s semaglutide is a glucagon-like peptide receptor agonist (GLP-1) indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
Semaglutide stimulates insulin secretion and lowers glucagon secretion in a glucose-dependent manner. Stimulation of the GLP-1 receptor also produces a delay in gastric emptying in the early post-prandial phase.
A key consideration regarding semaglutide is its ability to bind to albumin, which decreases renal clearance and protects semaglutide from metabolic degradation, Frank said.
Semaglutide’s approval is also significant because of its effect on reducing cardiovascular outcomes, as demonstrated in clinical trials.
There is an oral version of semaglutide in research, “that will be an interesting thing to see evolve,” Frank said during the presentation.
4. Benralizumab (Fasenra, AstraZeneca)
Benralizumab is an interleukin-5 receptor monoclonal antibody indicated for add-on maintenance treatment of severe asthma in patients 12 and older who have an eosinophilic phenotype.
“The underserved asthma population is an important patient group,” Frank said during the presentation. “About 5000 people per year die from asthma, and that number hasn’t changed in 20 years.”
Benralizumab, an IgG1 kappa monoclonal antibody, binds to the alpha subunit of the interleukin-5 receptor. Binding to immune effector cells such as natural killer cells leads to apoptosis of eosinophils and basophils through antibody-dependent cell-mediated cytoxicity.
5. Insulin aspart injection (Fiasp, Novo Nordisk)
Faster-acting insulin aspart injection is indicated to improve glycemic control in adults with diabetes.
Insulin aspart is recombinant human insulin with substitution of a proline with aspartic acid at B28. Faster-acting insulin aspart has niacinamide added to promote faster onset of initial absorption and glucose lowering effects, as well as L-arginine to stabilize the formulation.
The terminal half-life after SQ injection is 1.1 hours, which Frank said is vastly different from regular insulin.
First measurable effects are seen in 16 to 20 minutes, with appearance in blood in 2 1/2 minutes. The time of peak effect depends on the size of the dose.
Frank, T. New Drugs in Primary Care 2018. Presented at: 2018 ASHP Summer Meetings and Exhibition. June 2-6, 2018. Denver, Colorado.