Login
Paxlovid Trial Flops for COVID Pneumonia — Small Study Found No Decrease in Mortality Among Inpatients in Three Countries
We already found out this spring that nirmatrelvir/ritonavir is not as useful as it once was. Pfizer finally released results from its 2021-2022 trial showing that nirmatrelvir/ritonavir had no influence on symptoms among vaccinated patients with high risks or unvaccinated standard-risk patients. That study also found that hospitalizations were not statistically different across the nirmatrelvir/ritonavir and placebo groups but the study was not specifically designed to be definitive on that question.
But, we’ve been awaiting the results from a randomized controlled trial from the U.K. (the PANORAMIC study), which are expected to give key results on hospitalization and mortality for thousands of study participants.
In the meantime, we got some other data that is important. In late May, another U.K.-based study quietly preprinted findings from its randomized controlled trial of nirmatrelvir/ritonavir (conducted in 2022-2023 in the U.K., Indonesia, and Nepal). In this study, patients who were being hospitalized with COVID-related pneumonia were randomized to either receive nirmatrelvir/ritonavir or not. The patients’ mortality rates were compared after 28 days. There was absolutely no difference.
I ran some math known as power calculations — albeit informally — that I want to share with you. As it stands, nirmatrelvir/ritonavir was 0% effective in preventing death among patients hospitalized for COVID in the new RECOVERY study.
Ozempic Litigation’s New Judge Steps Into Big Battle
As U.S. District Judge Karen Marston in Philadelphia takes the helm of litigation involving Ozempic and similar drugs, she’ll step into a lively fight where early battle lines have already been drawn.
A former federal prosecutor who was nominated to the bench in 2019 by Donald Trump, Marston was selected by the Judicial Panel on Multidistrict Litigation on Thursday to take over product liability proceedings that plaintiffs’ lawyers expect to include more than 10,000 personal injury lawsuits.
Marston can expect the multidistrict litigation to receive extensive media attention, given the widespread use of the medications amid the so-called obesity epidemic in the U.S.
About one in eight U.S. adults have taken a drug belonging to the GLP-1 class of medications, my Reuters colleagues reported in May, citing a Kaiser Family Foundation poll. The self-injectable drugs include Novo Nordisk’s diabetes drug Ozempic and weight-loss treatment Wegovy, along with Eli Lilly‘s Mounjaro, Trulicity and Zepbound.
Plaintiffs in court documents say the drugmakers failed to adequately warn that their medications can potentially cause “prolonged, life-threatening digestive dysfunction.” Alleged side effects include gastroparesis, which prevents the stomach from emptying properly, as well as severe vomiting, bowel obstruction and gallbladder injuries.
To Address the Opioid Crisis, Pharma Should Learn From the Auto Industry
The Centers for Disease Control and Prevention (CDC) recently released its yearly examination of deaths attributed to drug overdose. This year’s results were a sobering reminder of the continuing impact that illicit drugs have had on our society, though an encouraging trend may have emerged.
According to the report, more than 100,000 people died from drug overdoses in 2023. Of those deaths, over 81,000 were from opioids, and more than 76,000 were due to synthetic opioids. While these are still tragically high numbers, for the first time in five years the annual death rate related to opioid overdose witnessed a slight decline.
The hope is that these data are a first indicator that the collective effort by drug support groups, law enforcement, first responders, and various other groups has enacted real and meaningful changes to curtail the opioid epidemic. For the pharmaceutical industry, which must shoulder the blame, the time to make positive societal change is now. The situation is analogous to what happened some 50 years ago in the automobile industry, when carmakers, alongside government regulators and safety watchdogs, shifted their outlook and brought meaningful changes to accelerate safety-minded innovation that saved countless lives.
Three-Dose Lyme Vaccine Candidate Stimulates Immunogenicity, Appears Safe — but Public Acceptance of a Vaccine Requiring Multiple Boosters Could Be Problematic, Experts Say
An investigational three-dose Lyme vaccine (VLA15) against Borrelia outer surface protein A (OspA)-specific serotypes generated immunogenicity and appeared safe, according to results of two linked phase II trials.
The VLA15 vaccine contains three lipidated fusion proteins that each link the C-terminal domains of two OspA serotypes, so that it targets six serotypes in total. In animal studies, VLA15 induced protection in mice from Borrelia species common in North America (B. burgdorferi) and Europe (B. burgdorferi, B. afzelii, B. garinii, and B. bavariensis).
No Lyme borreliosis vaccines are available for use in humans, and the VLA15 vaccine is the only one in advanced clinical development, the authors pointed out. “These findings support the continued development of a 180 µg VLA15 dose administered using an extended schedule to prevent Lyme borreliosis, which remains a common and growing threat in regions of the Northern Hemisphere,” Eder-Lingelbach and colleagues wrote.
The editorialists noted that the VLA15 vaccine required multiple initial doses to induce an immune response protective against Lyme borreliosis, and rapid drops in the titers after the third dose could mean that more than one booster dose per year might be necessary to maintain protective levels of antibodies. “Public acceptance of multiple vaccine doses could be problematic,” they pointed out.
U.S. FDA Staff Raise No Major Concerns About Eli Lilly Alzheimer’s Drug
An FDA analysis of trial data for Eli Lilly‘s (LLY.N) experimental Alzheimer’s drug donanemab released on Thursday revealed no red flags but raised questions about the safety of the treatment for patients with early-stage disease.
The drug is a potential rival to Eisai (4523.T) and Biogen’s (BIIB.O) Leqembi, which won approval last July. Both treatments are antibodies designed to remove toxic beta-amyloid plaques from the brains of people with early Alzheimer’s disease.
An outside panel of FDA advisers will consider the staff’s view during a meeting on Monday in which they will vote on whether the drug’s benefits outweigh its risks, according to documents published on the agency’s website. The panel’s recommendations are non-binding but typically followed by the U.S. Food and Drug Administration.
If donanemab is approved, FDA staff said they expect its prescribing label to highlight several risks and strategies to mitigate those risks, which include brain swelling and bleeding, especially in people with two copies of a gene called ApoE4.
CDC Recommends Antibiotic Doxycycline to Protect Against STIs After Potential Exposure
Doxycycline, an antibiotic widely used to combat acne, malaria and Lyme disease, has been recommended by the CDC for use in the United States by gay and bisexual men and transgender women after having unprotected sex to ward off sexually transmitted infections (STIs).
Post-exposure prophylaxis (PEP) treatment with a 200 mg dose of doxycycline is recommended within 72 hours of having unprotected oral, vaginal or anal sex and comes as infections for syphilis, gonorrhea and chlamydia are on the rise in the U.S., disproportionally affecting men who have sex with men and transgender women.
Three trials have shown that post-exposure prophylaxis (PEP) use of doxycycline can reduce the risk of syphilis or gonorrhea infection by more than 70% and chlamydia infection by 50%, the CDC said.
