Breakthroughs Blog: Medicines

Prior to COVID-19, tuberculosis (TB), another airborne disease, was the world’s leading global infectious disease killer, claiming the lives of around 1.5 million people annually. Insufficient and inadequate tools and treatments, as well as the growth of drug resistance, have challenged global efforts to bring this epidemic to an end. But scientists hope that tide will turn as more new technologies and innovations advance to market. In recognition of #WorldTBDay, test your knowledge of innovations to #EndTB with GHTC’s quiz below: Loading... (function(i, s, o, g, r, a, m) { var ql = document.querySelectorAll('A[quiz],DIV[quiz],A[data-quiz],DIV[data-quiz]'); if (ql) { if (ql.length) { for (var k = 0; k

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. Novavax’s COVID-19 vaccine has an overall efficacy of 89.7 percent, with 100 percent efficacy against severe disease, according to final results of its phase 3 trial in the United Kingdom. The results, released Thursday and not yet published in a peer-reviewed journal, showed 96.4 efficacy against the original strain of the COVID-19 virus and 86.3 percent against the B.1.17 variant, first identified in the United Kingdom. The company also announced results from a phase 2b trial in South Africa, which showed 48.6 percent efficacy overall but maintained 100 percent efficacy against severe disease. Phase 3 trials in the United States and Mexico are ongoing. Novavax plans to apply for regulatory approvals around the world, including for use by the global vaccine initiative COVAX, to which Novavax pledged to provide 1.1 billion doses.An antibody cocktail developed by Eli Lilly decreased risk of hospitalization and death due to COVID-19 by 87 percent when compared to a placebo, the company said Wednesday. The antibody duo, a lower-dose combination of bamlanivimab and etesevimab, received emergency use authorization from the US Food and Drug Administration (FDA) in February based on previous trial data indicating a 70 percent reduction in hospitalizations and deaths using higher doses. The treatment showed complete protection against death in both phase 3 cohorts. Eli Lilly has a supply deal with United States for 100,000 doses of the treatment, set to be delivered by the end of the month, and the company has now partnered with Amgen to help produce up to 1 million doses of the cocktail by the end of the year. On Thursday, results from a long-term study in South Africa showed almost all patients who received a new treatment for highly drug-resistant tuberculosis remained clear of the disease two years after the trial. The six-month, all-oral regimen of bedaquiline, pretomanid, and linezolid (BPaL) treats highly drug-resistant strains of tuberculosis and shortens the treatment period from two years, with limited side effects. The new findings come from analysis of the Nix-TB trial, conducted by the TB Alliance of South Africa, which tested the BPaL regimen on 109 patients at three sites in the country. Preliminary trial results showed a 90 percent success rate after six months of treatment and six months of post-treatment follow-up, and according to the new data, only two patients had challenges by two years after the treatment.

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. Johnson & Johnson’s (J&J) one-dose COVID-19 vaccine candidate showed 66 percent efficacy in preventing moderate to severe disease 28 days after vaccination, according to results from a phase 3 global study released Friday. The trial data differed across geographies, with the vaccine demonstrating 72 percent efficacy among participants in the United States, 66 percent efficacy in Latin America, and 57 percent efficacy in South Africa—adding to concerns about diminished vaccine efficacy against the COVID-19 variant circulating in South Africa and recently detected in the United States. The J&J vaccine also showed complete protection in preventing hospitalization and death due to COVID-19, as well as 85 percent efficacy in preventing severe forms of the disease. J&J plans to apply for emergency use authorization (EUA) from the US Food and Drug Administration (FDA) in early February.On Thursday, Novavax announced 90 percent efficacy of its two-dose COVID-19 vaccine candidate in preliminary results from a phase 3 clinical trial in the United Kingdom, while results from a separate trial indicated 49 percent efficacy of the vaccine in South Africa. The company has said it is already working on a new version of the vaccine designed to combat more infectious strains of the virus, which could also be used as a booster for already-inoculated individuals. The vaccine is also undergoing testing in the United States and Mexico, supported by Operation Warp Speed, which is expected to complete phase 3 enrollment in the first half of February. Novavax expects to file for emergency authorization in the United Kingdom in the coming months once it has final data from the UK trial.In preliminary data released Tuesday, Regeneron reported that its antibody cocktail REGEN-COV was 100 percent effective at preventing symptomatic COVID-19 in participants of an ongoing phase 3 trial among people at high risk of contracting COVID-19 due to exposure to family members with the disease. The data also showed a 50 percent reduction in the overall rate of infection. REGEN-COV was granted an EUA from the FDA in November as a treatment method for patients with mild COVID-19 at high risk of progressing to severe infection, and pending a full readout expected next quarter from the phase 3 prevention trial, the company intends to file to expand the EUA for use as a “passive vaccination” method.

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) on Thursday approved Cabenuva as the first long-acting injectable HIV treatment for patients in stable condition. Cabenuva—a combination of cabotegravir and rilpivirine, injected separately—was shown in clinical trials to suppress HIV to undetectable levels for two years when administered once a month. The monthly injectable medication regimen, developed by ViiV Healthcare, will pose an alternative to existing HIV treatment methods that require daily pills. However, the Cabenuva approval covers only stable HIV patients—those who took daily pills and had undetectable HIV levels before entering the trial—while an ongoing trial is evaluating its efficacy in people unable to take regular oral medications. The list price of the newly approved treatment is roughly $6,000 for the initial dose, followed by around $4,000 per month.Newly inaugurated President Joe Biden last week reversed the former administration’s request to withdraw the United States from the World Health Organization (WHO) and indicated the country will support the WHO-led Access to COVID-19 Tools (ACT) Accelerator, including its global vaccine initiative known as COVAX. The ACT Accelerator aims to ensure all countries have access to COVID-19 treatments, diagnostics, and vaccines, with COVAX intending to secure and distribute 2 billion vaccine doses by the end of 2021—a goal for which fundraising targets remain unmet. The United States has historically been the largest donor to WHO, providing financial support for a wide range of program areas, including pandemic preparedness. In remarks during the WHO Executive Board meeting Thursday, Dr. Anthony Fauci announced the United States’ commitment to WHO and the global COVID-19 response, and WHO Director-General Tedros Adhanom Ghebreyesus welcomed the renewed partnership.On Thursday, Eli Lilly announced its monoclonal antibody prevented COVID-19 infections in a clinical trial among nursing home residents and facility staff. The trial results, released in a press release from the company and currently not published or peer reviewed, showed symptomatic COVID-19 infections were reduced by 57 percent among all participants and by 80 percent among just nursing home residents. Eli Lilly’s chief scientific officer emphasized that the antibody should not be seen as competition to vaccines, but that it could be useful during COVID-19 outbreaks in places vaccines have not reached. The antibody, bamlanivimab, was authorized by the FDA in November to treat COVID-19 patients at risk of severe disease, and Eli Lilly plans to discuss with the FDA whether a new emergency authorization is needed for use in COVID-19 prevention.