Pleuromutilin antibiotics, meningococcal disease, tuberculosis, a new fluoroquinolone to treat acute bacterial skin and skin structure infections, and WHO’s position on HPV vaccine recommendations makes up this week’s Top 5 articles.
According to Joseph Larsen, PhD, Director of the Biomedical Advanced Research and Development Authority (BARDA) with the US Department of Health and Human Services, developing new antibiotic agents can take years, and only become profitable after an average of about 23 years. In addition, in an interview with Contagion®, Robert W. Malone, MD, MS, CEO/CSO of Atheric Pharmaceuticals, LLC, mentioned that getting a new drug or vaccine on the market takes around $1 billion and approximately 10 years. However, there is less incentive in creating new antibiotics because of revenue. According to Dr. Larsen, “for the last 6 antibiotics approved in the United States, the projected first 2 years’ sales ranged between $30 million to $80 million, which is not much when compared to medications used to treat more chronic diseases, which routinely have first 2 years’ sales in excess of a billion dollars.”
In the most recent study, Dr. Herzon and his colleagues were able to “prepare an isomer of pleuromutilin—a compound that has the same connectivity, but with a different arrangement of atoms—and rearrange it in the final steps of the synthesis to pleuromutilin.” With this, the research group was able to fully synthesize pleuromutilin, which may allow for the development of more antibiotics. The group outlined their complete synthesis methods in their study.
Learn more about the Yale study here.
The Centers for Disease Control and Prevention (CDC) report that rates of meningococcal disease have been on the decline in the United States; in fact, the rates are perceived to be at “historic lows.” Unfortunately, other regions of the globe are not so lucky.
One such region that holds the highest incidence of disease is what is referred to as the “meningitis belt,” which is comprised of 26 countries located within sub-Saharan Africa. Here, “major epidemics” are known to spring up every 5 to 12 years, “with attack rates reaching 1,000 cases per 100,000 population” compared with annual attack rates of 0.3 to 3 per 100,000 population in other regions of the world.
Continue reading about efforts to combat meningococcal disease in the “meningitis belt” here.
Based on their findings, the authors believe vitamin A deficiency has a potential role in identifying individuals at risk for TB, and that vitamin A supplementation may be an effective—and cost-effective—method for preventing new infections. On the latter point, Dr. Murray and her team are in the process of applying for a National Institutes of Health (NIH) grant to fund a study assessing the possible benefits of vitamin A supplementation in this setting.
“This is one of the strongest risk factors reported in a large epidemiological study in years,” Dr. Murray said in a statement released by Harvard Medical School in conjunction with the study’s publication. “If the link is affirmed in a clinical trial of vitamin A supplementation, it would make a powerful case for using this approach to prevent TB in people at high risk of disease. It’s exciting to think that something as simple and inexpensive as supplementing people’s diets with vitamin A may be a powerful tool for preventing TB.”
Learn more about this recent study here.
The US Food and Drug Administration (FDA) has just approved Melinta Therapeutics’ delafloxacin (Baxdela), a new fluoroquinolone drug designed to treat acute bacterial skin and skin structure infections in adults.
The Baxdela New Drug Application (NDA) approvals were supported by two phase 3 studies in patients with skin and skin structure infections, demonstrating that IV and oral Baxdela monotherapy was statistically non-inferior to the combination of vancomycin plus aztreonam at the FDA primary endpoint of early clinical response at 48-72 hours, according to a statement from Melinta.
Baxdela was well tolerated with a 0.9% discontinuation rate in the phase 3 studies due to adverse events. In addition, Baxdela has not shown any potential for QT prolongation or phototoxicity in definitive clinical studies. There have been no signals of adverse effects on liver function, kidney function, or glucose regulation in controlled clinical studies.
Continue reading about the Baxdela approval here.
The World Health Organization (WHO) reports that all 3 vaccines—bivalent, quadrivalent, and nonavalent—are “comparable” when it comes to “immunogenicity, efficacy, and effectiveness” in cervical cancer prevention. When it comes to choosing which vaccine to use, WHO suggests taking “locally relevant data” into consideration as well as factors such as “the scale of the prevailing HPV-associated public health problem” and the “population for which the vaccine has been approved.” The cost and nature of the vaccination program should also be considered.
A 2-dose schedule—with 6 months in between doses—is recommended for those who are receiving their first dose of the vaccine before 15 years of age. However, a 2-dose schedule is also acceptable for those who are over 15 years of age at the time of the second dose. WHO recommends a 3-dose schedule—to be taken at 0, 1, 2, 6 months—for all individuals over 15 years of age receiving their first dose; this dosing schedule is also recommended for those who are under the age of 15, who are HIV-infected or are otherwise immunocompromised.
Read more about WHO’s recommendations here.