FDA to review new treatments for urinary tract infections, pneumonia
Merck announced yesterday that the US Food and Drug Administration has accepted for priority review a New Drug Application (NDA) for the combination of relebactam and imipenem/cilastatin and a supplemental NDA for Zerbaxa (ceftolozane and tazobactam).
Merck is seeking approval for the combination of relebactam, an investigational beta-lactamase inhibitor, with imipenem/cilastatin to treat complicated urinary tract infections (cUTIs) and complicated intra-abdominal infections caused by certain susceptible gram-negative bacteria in adults with limited or no alternative therapies available. The supplemental NDA for Zerbaxa, which is already approved for patients with cUTIs, is to treat adults with nosocomial pneumonia, including ventilator-associated pneumonia, caused by certain susceptible gram-negative organisms.
"There is a major unmet need for new treatment options to address the growing danger of serious and potentially life-threatening infections caused by gram-negative bacteria," Nicholas Kartsonis, MD, senior vice president and head of clinical research for infectious diseases and vaccines at Merck, said in a press release. "In a space where there are currently very few treatment options, these filings underscore Merck's ongoing commitment to delivering new antibacterial agents to healthcare practitioners and patients."
Corresponding applications for both medicines have been filed with the European Medicines Agency.
Feb 5 Merck press release
CARB-X grant focuses on gram-negative superbugs
Today the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator, also known as CARB-X, announced an award of $4.4 million to Recida Therapeutics of Menlo Park, Calif., to develop a novel antibiotic targeting gram-negative superbugs.
"The world urgently needs new classes of antibiotics and other life-saving products to prevent, diagnose, and treat deadly infections," said Kevin Outterson, JD, executive director of CARB-X and a Boston University law professor, in a press release. "Recida's lead program inhibits LpxC, and would represent a new drug class against gram-negative superbugs, if approved by the FDA. The projects in the Powered by CARB-X portfolio are in early development, but if successful, they offer tremendous hope in the global fight against drug-resistant bacteria."
The money will help Recida prepare their drug, RC-01, for an Investigational New Drug (IND) application submitted to the US Food and Drug Administration (FDA). In preclinical testing, RC-01 inhibited LpxC, a key enzyme in the outer membrane of gram-negative bacteria, including Enterobacteriaceae and Pseudomonas aeruginosa.
Recida's RC-01 is 1 of 12 new antibiotics in CARB-X's portfolio. Established in 2016, CARB-X will invest $500 million in antibacterial research and development over a 5-year span.
Feb 6 CARB-X press release
Educational intervention in China cuts prescribing for kids' respiratory infections
Chinese, Canadian, and British researchers report that an educational intervention to reduce antibiotic prescribing in children with upper respiratory tract infections (URTIs) significantly cut the prescribing rate in rural Chinese primary care facilities. The study appeared yesterday in PLOS Medicine.
The study was a long-term follow-up to an unblinded cluster-randomized controlled trial of 25 primary care facilities in two counties in rural China. That study found that the intervention, which included clinical guidelines, monthly prescriber-review meetings, doctor-patient communication skills training, and educational materials for caregivers, reduced the antibiotic prescribing rate among children aged 2 to 14 with URTIs by 29 percentage points from the baseline within 6 months.
In the long-term follow-up, the researchers looked at trial outcomes in the 14 facilities (7 intervention facilities and 7 control facilities) in one county at 18 months after the start of the intervention (12 months after the trial ended) and conducted interviews to understand how the interventions were sustained. After adjusting for patient and prescriber covariates, they found that, compared to the non-intervention facilities, the antibiotic prescribing rate in the intervention facilities was 36 percentage points lower than it was at baseline.
Providers at two of the intervention facilities reported better clinical knowledge in appropriate use of antibiotics, enhanced communication skills with patients and caregivers, and increased confidence in not prescribing antibiotics for common URTIs, even when requested. In addition, better-performing facilities reported more frequent peer-review meetings.
Though the authors say they would not expect the improvement in antibiotic prescribing to be sustained for longer time periods without refresher training sessions and regular supervision and monitoring, they believe this type of intervention could be successful in other low- and middle-income countries, where roughly 80% of URTIs are treated with antibiotics.
Feb 5 PLOS Med study