FDA on Wednesday approved the first-ever vaccine for respiratory syncytial virus (RSV), in today's bite-sized hospital and health industry news from Indiana, Maryland, and Virginia.
- Indiana: Eli Lilly on Wednesday announced plans to submit its early-stage Alzheimer's treatment for FDA approval after study results found that the drug slowed cognitive and functional decline. The treatment, called donanemab, is an intravenous infusion that targets amyloid — a substance that forms plaque in the brain and is believed to worsen Alzheimer's disease. Recently, FDA rejected the drug because it wanted to see data from more patients. According to Lilly's chief scientific and medical officer, Daniel Skovronsky, the new study gives FDA the additional data it requested. While the treatment was designed to clear amyloid, it does not cure the disease or stop it from progressing. Still, "[t]he drug effect is very strong," Skovronsky said. In the company's Phase 3 study of more than 1,730 patients, the treatment slowed decline by 35% over 18 months, compared with individuals who received a placebo. Roughly 47% of the patients who received the drug had no decline 12 months after their treatment began. "These are levels of efficacy that just haven't been seen before in Alzheimer's, setting a new benchmark for what's possible in this disease," Skovronsky said. (Loftus, Wall Street Journal, 5/3)
- Maryland: FDA on Wednesday approved the first-ever vaccine for RSV. GlaxoSmithKline's (GSK) Arexvy was approved for use in adults aged 60 and older. "Older adults, in particular those with underlying health conditions, such as heart or lung disease or weakened immune systems, are at high risk for severe disease caused by RSV," said Peter Marks, director of the FDA's Center for Biologics Evaluation and Research. "Today's approval of the first RSV vaccine is an important public health achievement to prevent a disease which can be life-threatening and reflects the FDA's continued commitment to facilitating the development of safe and effective vaccines for use in the United States." According to Phil Dormitzer, GSK's SVP and global head of vaccines research and development, many stakeholders in the field of RSV research and prevention see Arexvy's approval as a promising sign, with several other vaccine candidates under development. "There's just the broad excitement of finally, after all these years, having good options emerging for RSV," Dormitzer said. "I guess also the triumph of the basic science — the fact that a very basic study … really changed the hunt for a vaccine and led to one or even more than one potential products coming forward to prevent RSV." (Goodman, CNN, 5/3; Branswell, STAT, 5/3; Gonzalez, Axios, 5/3)
- Virginia: The Drug Enforcement Agency (DEA) released a proposal that would require patients who get a telehealth prescription for buprenorphine to visit a provider within 30 days — a move that could change how over 1 million Americans access the drug. Buprenorphine is an opioid-substitute treatment that helps stop cravings and block withdrawal symptoms for individuals with opioid-use disorder. To ensure access during the pandemic, telehealth providers were allowed to prescribe the drug without a medical visit. Under the proposed rules, all patients will be required to visit their doctor or a clinic within 30 days of receiving a buprenorphine prescription. Advocates warn that DEA's new rule could hinder access, especially for patients living in rural areas without access to a clinic. As the agency drafts its final rule, it will consider almost 3,000 public comments. While DEA has not announced when the final rules will be released, they are expected after the public health emergency ends May 11. (Alltucker, USA Today, 5/2)