FDA has placed a clinical hold on Verve Therapeutics' gene editing treatment for heart disease, in today's bite-sized hospital and health industry news from Maryland, Massachusetts, North Carolina, and more.
- Maryland/Massachusetts: FDA has placed a clinical hold on Verve Therapeutics' Phase 1 trial for its experimental gene editing treatment for heart disease. In a quarterly earnings statement, Verve did not reveal what triggered FDA's decision, but said that it will work to resolve the hold "as promptly as possible." Outside of the United States, Verve is currently testing its gene editing treatment in patients with a rare, inherited form of high cholesterol in both the United Kingdom and New Zealand. So far, three patients have been treated, and there have not been any treatment-related adverse events. An independent data safety monitoring board has cleared the company to begin testing a higher dose, and initial results from these trials are expected to be ready by the second half of 2023. (Armstrong, Fierce Biotech, 11/7; Fidler, BioPharma Dive, 11/7)
- North Carolina/Pennsylvania: GSK last week announced that its experimental antibiotic gepotidacin was highly effective in treating urinary tract infections (UTI) among 3,000 women in a clinical trial, performing as least as well as the current front-line treatment nitrofurantoin. The drug, which was developed in partnership with the U.S. government and funded by the Biomedical Advanced Research and Development Authority, is the first antibiotic developed to treat UTIs in over 20 years. According to the company, an independent data monitoring committee recommended the study be stopped early since the drug had already proven to be effective at resolving UTI symptoms and getting rid of the bacteria that caused it. Currently, GSK is preparing the results for publication in a medical journal and plans to submit its data to FDA for approval next year. (Goodman, CNN, 11/3)
- Across the United States: Covid-19 vaccines administered by pharmacists during the pandemic helped prevent 1 million deaths and saved the United States $450 billion in health care costs, according to a new study published in the Journal of the American Pharmacists Association. For the study, researchers analyzed data from published literature, government agencies, and professional pharmacy associations to determine the number of Covid-19 vaccines administered by pharmacists. Overall, the researchers estimated that pharmacists administered over 270 million Covid-19 vaccines, which "plausibly accounted" for more than 50% of all Covid-19 vaccinations in the country. Since the study was published, the number of vaccinations administered by pharmacists has increased to 282 million. "This is the first peer-reviewed study which documents the incredible impact that pharmacy had on the health and well-being of our nation, across the entire spectrum of potential patient interventions," said Ilisa Bernstein, interim CEO and EVP at the American Pharmacists Association. "There's only one conclusion to draw from this impressive report—the work of pharmacists during the pandemic has been heroic." (Twenter, Becker's Hospital Review, 11/4)