What You Need to Know
The Biden Administration's Department of Health and Human Services is taking proactive steps to address the growing threat of antibiotic-resistant bacteria by allocating $100 million to the Defeating Antibiotic Resistance through Transformative Solutions (DARTS) project.
The voluntary recall of Scynexis' antifungal medication, Ibrexafungerp, due to potential cross-contamination with a non-antibacterial ß-lactam drug substance highlights the importance of quality control and safety measures in pharmaceutical manufacturing.
The confirmation of a case of bubonic plague in Colorado underscores the importance of public health agencies and officials remaining vigilant, even in the face of rare diseases.
Biden Administration Will Invest $100 Mllion to Study, Reduce AMR
This week, the Biden Administration’s Department of Health and Human Services (HHS), through the Advanced Research Projects Agency for Health (ARPA-H) announced a new project to combat the growing threat of antibiotic-resistant bacteria. They have allocated $100 million to the project.
“Antibiotic resistance is an urgent and growing threat, and we do not currently have the tools we need to combat it. We must combine better stewardship of antibiotics with novel technologies in order to save lives—exactly what this award will do,” said HHS Secretary Xavier Becerra in a statement.
ARPA-H is funding through its Open Broad Agency Announcement (Open BAA) the Defeating Antibiotic Resistance through Transformative Solutions (DARTS) project. DARTS focuses on developing a set of diagnostic and experimental platforms that that can reveal insights into how antibiotic resistance starts, search for new antibiotics, and rapidly identify the right antibiotic to prescribe for a particular infection in real time.
The technology, if successful, could rapidly identify bacteria that can evade antibiotic treatments and quickly find the right compound to treat a specific infection. The goal is to create a platform that can be easily employed at any hospital or clinic and would advance US government efforts on surveillance and stewardship.
“Quickly identifying the right antibiotic empowers healthcare providers to fight off superbugs and return patients to health,” said ARPA-H Program Manager Paul Sheehan, PhD. “With DARTS, we aim to develop a compact diagnostic tool for the most problematic bacterial strains.”
DARTS will aid in the stewardship of current antibiotics helping to ensure that patients get the antibiotics they need and not ones that they do not need. This is a critical component of the strategy to preserve the effectiveness of antibiotics over time and slow resistance to these drugs. The DARTS project further aims to serve as a rapid platform for the discovery of new antibiotics from natural samples. Harvard Medical School in Cambridge, Massachusetts leads the multi-institution research team under an agreement of up to $104 million.
The ARPA-H Open BAA seeks transformative ideas for health research or technology breakthroughs. Continued support of each award is contingent on projects meeting aggressive milestones. The Open BAA began accepting abstracts in March 2023 and is open until March 2024. Projects will be funded on a rolling basis. To learn more about projects as they are awarded, visit https://arpa-h.gov/engage/baa/awardees/.
Scynexis Recalls its Antifungal
On Wednesday, Scynexis announced it was conducting a nationwide voluntary recall of its thereapy ibrexafungerp tablets (Brexafemme) to the consumer level in the US market due to potential cross contamination with a non-antibacterial ß-lactam drug substance in the ibrexafungerp citrate used to manufacture the tablets. Specifically, they are recalling 2 lots.
According to the company, ibrexafungerp is dispensed in a carton and packaged in blister packs with four 150-mg tablets (NDC 75788-115-04). Ibrexafungerp tablet for oral administration is a purple, oval, biconvex shaped, film-coated tablet debossed with 150 on one side and SCY on the other side. The affected Ibrexafungerp lots include the following lots and expiration dates: LF21000008 (expiration date 11/2023) and LF22000051 (expiration date 11/2025). The recalled lots were distributed nationwide to wholesalers across the US, beginning in December 2022.
Ibrexafungerp is an antifungal indicated for the treatment of vulvovaginal candidiasis (VVC) and the reduction of the incidence of recurrent vulvovaginal candidiasis (RVVC). The FDA approved it in June 2021 for this indication. The therapy, which represents the first approved drug in a novel antifungal class in more than 20 years, was approved based on positive results from 2 phase 3 studies in which oral ibrexafungerp demonstrated efficacy and a favorable tolerability profile in women with VVC.
In its statement, Scynexis provided a Risk Statement, which said: “The potential cross contamination with a non-antibacterial beta-lactam drug substance could lead to hypersensitivity reactions such as swelling, rash, urticaria and anaphylaxis, a potentially life-threatening adverse reaction. To date, Scynexis has not received any reports of adverse events established to be due to the possible beta-lactam cross contamination.”
Scynexis is working with Sedgwick to manage the recall of the product down to the consumer level. Consumers with questions regarding this recall can contact Sedgwick at 1-877-551-7154. Office hours: Monday to Friday, 8:00 AM to 5:00 PM ET.
Consumers should contact their healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Case of Bubonic Plague
Public health officials in Colorado stated one person who died in Archuleta County had a confirmed case of plague. The Colorado Department of Public Health and Environment (CDPHE) and San Juan Basin Public Health (SJBPH) are investigating the case.
“On behalf of all of us at SJBPH, our hearts go out to the family while we work with CDPHE to conduct a thorough investigation to keep residents safe,” said Tiffany Switzer, interim executive director of SJBPH. “While this disease is very rare, it is important to be aware of how you can be exposed and the symptoms it can cause. If you think you have symptoms consistent with plague, seek health care immediately and let them know you may have been exposed.”
No other information about the person who contracted the disease was provided.
Plague is frequently detected in rock squirrels, prairie dogs, wood rats, and other species of ground squirrels and chipmunks. In their statement, SJBPH said it investigates prairie dog population die-offs for the presence of plague. If an active colony of prairie dogs suddenly disappears, please report this to SJBPH. Residents should not eradicate or kill prairie dogs on their property as this increases the risk of exposure to plague-infested fleas.
Plague is caused by the bacterium, (Yersinia pests), which can be transmitted to humans by the bites of infected fleas or by direct contact with infected animals.
The CDC says clinicians should treat patients right away and not wait for diagnostic tests if they suspect plague.
“The decision to initiate antibiotic therapy for plague should be made based on clinical signs and symptoms and a careful patient history. A recent flea bite, exposure to areas with rodents, or contact with a sick or dead animal are risk factors for plague in endemic areas,” CDC writes on its site.