Breakthroughs Blog: FDA

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. Data from late-stage trials showed that Pfizer’s experimental antibiotic drug combination was well-tolerated and effective in treating complicated infections caused by drug-resistant bacteria. The combination, which includes the experimental mix aztreonam-avibactam, existing generic drug metronidazole, and two older antibiotics: meropenem and colistin, is aimed at treating complicated intra-abdominal infections and some types of hospital-acquired pneumonia caused by gram-negative bacteria. The study underscores that innovative, novel antibiotics continue to be an important goal in the face of the rising global threat of antimicrobial resistance.Last week, the US Food and Drug Administration (FDA) approved Pfizer’s Abrysvo vaccine for respiratory syncytial virus (RSV) following strong results from a phase 3 trial, making it the second vaccine to protect older adults from RSV approved in recent months. Both vaccines will not be available until the US Centers for Disease Control and Prevention recommends them, which the agency is expected to do soon. Experts have highlighted the great potential for both vaccines to drastically reduce the number of infections and hospitalizations in adults that result from the virus every year.A new study showed the success of implementing shorter treatment regimens for drug-resistant tuberculosis (TB) in a small cohort in the United States. The six-month, all-oral bedaquiline, pretomanid, and linezolid (BPaL) regimen for rifampin-resistant TB was implemented in 70 patients in 2019, shortly after FDA approval of the regimen. The promising results lend support to the early implementation of new TB treatments and highlight the promise of further innovation to reduce the burden of TB, especially drug-resistant TB, in the United States and around the world.

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email.The US Food and Drug administration (FDA) last week approved the first-ever vaccine for respiratory syncytial virus (RSV). GSK’s Arexvy vaccine is a single shot intended for use in adults aged 60 and older and could be available as soon as fall of this year, as long as the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices provides further approval. RSV, which has an annual global death toll of 160,000 people, has challenged vaccine researchers for six decades. Building on those years of efforts, GSK’s Arexvy showed strong results in an ongoing trial of nearly 25,000 adults. Further FDA approvals for RSVP vaccines developed by Pfizer, Moderna, and Bavarian Nordic could follow soon, with the decision on Pfizer’s candidate expected as soon as this month.Last week at the 2nd Global Forum on Childhood Pneumonia in Madrid, Spain, the Bill & Melinda Gates Foundation announced a nearly US$200 million commitment, to be awarded over the next year and a half, to support the development and delivery of affordable vaccines for some of the leading causes of childhood mortality, including pneumonia, meningitis, neonatal sepsis, and RSV. This includes supporting a more affordable next-generation pneumococcal conjugate vaccine, Pneumosil, developed by the Serum Institute of India and PATH and advancing a Group B streptococcus vaccine entering phase III trials later this year. The foundation is partnering with the companies developing these vaccines to ensure they are available and affordable to Gavi and low- and middle-income countries, therefore narrowing the gap between the rollout of vaccines in high-income and Gavi-supported countries.A new gold-standard clinical trial in Kenya showed that a single dose of the human papillomavirus (HPV) vaccine may be as effective as two or three doses over at least three years. Deploying a single-dose strategy could dramatically lower the rates of cervical cancer and other associated diseases, as well as extend vaccine supplies, lower costs, and simplify distribution, especially in low- and middle-income countries. At least 24 countries have already shifted to a one-dose approach, and this trial could make it a more widely adopted strategy, which the World Health Organization estimates could prevent 60 million cervical cancer cases and 45 million deaths worldwide over the next 100 years.

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email.Last week, a US Food and Drug Administration (FDA) advisory panel recommended approval of two vaccines for respiratory syncytial virus (RSV) for adults 60 and older, one by Pfizer and one by GlaxoSmithKline. The agency could grant formal approval to the vaccines in the coming months, making them the first shots available against RSV, a disease responsible for significant deaths and hospitalizations among older adults and young children. Other vaccines, as well as monoclonal antibody treatments, also in the pipeline could additionally address the yearly burden of RSV.The US Centers for Disease Control and Prevention (CDC) has issued a warning about a rise in extensively drug-resistant cases of Shigella, especially in gay and bisexual men, in the United States and other countries. Shigella is a highly infectious bacterial infection that causes an inflammatory diarrheal condition and is spread when infected fecal matter enters the mouth or nose. The European Centre for Disease Prevention and Control also released an alert about possible cases among recent travelers. Doctors have faced major challenges in identifying viable alternative antibiotics to treat these cases, underlining the need for greater focus on the research and development of new antibiotics.This year’s Conference on Retroviruses and Opportunistic Infections saw a myriad of presentations on how best to expand global access to the cabotegravir, or CAB-LA, which is a long acting, injectable form of preexposure prophylaxis (PrEP) used to prevent HIV infection. CAB-LA joins oral PrEP and the recently approved dapivirine vaginal ring as a third safe and effective biomedical HIV prevention option, for the first time allowing people an authentic choice among products. However, to ensure access and availability of these products, there remains a need for additional research on the use of CAB-LA in certain patient populations, including among people who inject drugs, and further research on effective delivery methods to expand uptake of oral PrEP.

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email.The World malaria report 2022, published last Thursday, found that progress in the fight against malaria has been steady, despite setbacks due to the COVID-19 pandemic. In order to strengthen the global response to malaria, investment is needed to close the funding gap and ensure money is available for the research and development (R&D) of new tools. There is a robust R&D pipeline of innovative technologies for malaria control including new long-lasting bednets, diagnostic tests, next-generation medicines, and other vaccines that will be essential to address the growing challenges of antimicrobial resistance and the spread of the Anopheles stephensi malaria vector in urban areas.Despite rising COVID-19 cases in the United States, no monoclonal antibodies treatments are available for use as the US Food and Drug Administration paused the emergency authorization for the last remaining antibody treatment developed by Eli Lilly because it is not as effective against newer variants. There are other medications aimed at preventing COVID-19 that are currently authorized, including Evusheld and Paxlovid, but these treatments may not be as effective against new variants and may not be available for everyone. New antiviral treatments are in development, including one drug developed by researchers at the Dana-Farber Cancer Institute and another by Shionogi, which has received emergency authorization in Japan.The spread of Sudan ebolavirus in Uganda has slowed dramatically, raising questions about whether the trial testing vaccine efficacy that was expected to begin shortly can go on due to reduced numbers of potential participants. A cancelled trial would be considered by many a loss given the incredible amount of effort that has gone into securing the vaccines, permissions, and funding for the trial, as well as the interest in testing new vaccines that could be effective against Sudan ebolavirus. Looking forward, stockpiling experimental vaccines and pre-agreed trial protocols could ensure readiness for any future Sudan outbreaks.