Breakthroughs Blog: Medicines

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.On Thursday, AstraZeneca and Regeneron reported data on the effectiveness of their COVID-19 antibody treatments against the omicron variant of the virus. Regeneron’s therapy, REGEN-COV, is less effective against omicron, though is still active against the delta variant, confirming indications from lab tests and computer modelling late last month. AstraZeneca’s antibody cocktail, Evusheld, retained neutralizing activity against omicron, according to the lab study results. Earlier last week, researchers also announced that Eli Lilly’s antibody treatment lost effectiveness against omicron in lab tests, while GSK-Vir Biotechnology’s antibody treatment retained neutralizing activity against all tested coronavirus variants, including omicron. The omicron variant has been detected in 77 countries since it was first identified three weeks ago, driving concerns that its large number of mutations could help it evade protection by COVID-19 vaccines and therapeutics.A new needle-free COVID-19 vaccine to protect against future virus variants is being tested in the United Kingdom, researchers announced last week. The DIOS-CoVax vaccine, developed by scientists at Cambridge University, is administered through spring-powered jet injection and uses predictive methods to mimic the wider family of coronavirus antigens with the goal of providing more protection than existing vaccines. The trial, which will include participants aged 18 to 50, is a first step toward a universal coronavirus vaccine to protect people from COVID-19 variants and future coronaviruses—a vital part of next-generation vaccine candidates to help protect the world from the next virus threats, according to a researcher involved in its development.An antimalarial drug in development by Zydus Cadila in partnership with the Medicines for Malaria Venture received orphan drug designation from the US Food and Drug Administration (FDA) on Thursday. The designation makes the drug eligible for certain development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions, and seven-year marketing exclusivity upon FDA approval. The drug, ZY19489, is a novel antimalarial compound that combats all current clinical strains of P. falciparum and P. vivax malaria, including drug-resistant strains. A phase 1 study indicated the drug has a long half-life and potential as a single-dose cure for malaria.

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. Pfizer signed a voluntary license agreement last week to share the patents and knowledge to manufacture its COVID-19 antiviral pill, Paxlovid, with the Medicines Patent Pool (MPP). The agreement will allow MPP to grant sublicenses to qualified generic medicine manufacturers to supply the treatment to 95 countries once regulatory authorization or approval is granted. Paxlovid, a five-day oral treatment regimen, was shown to reduce the risk of COVID-19-related hospitalization and death by 89 percent in phase 2/3 clinical trial results. The new licensing agreement will allow the rapid scale-up of manufacturing of the treatment, which is particularly well-suited for low- and middle-income countries and would contribute to global efforts to combat COVID-19, according to the executive director of MPP. AstraZeneca’s antibody cocktail is more than 80 percent effective at preventing symptomatic COVID-19, according to results released by the company Thursday. The study—in which more than 75 percent of participants had comorbidities that put them at risk of developing severe COVID-19—showed the long-acting antibody combination reduced the risk of symptomatic COVID-19 by 83 percent over a period of six months. There were also no cases of severe disease or death among those who received the antibody cocktail, which is administered as a one-time 300-mg dose in two separate, sequential shots. The preventative treatment is intended to help at-risk individuals, particularly those who do not develop an adequate immune response to the COVID-19 vaccine, to prevent serious illness from the virus. Merck KGaA (EMD Group) and the Pediatric Praziquantel Consortium have announced pivotal phase 3 trial results for schistosomiasis treatment arpraziquantel, indicating the drug has met the primary endpoint of clinical cure among children ages three months to six years. Arpraziquantel—an orally dispersible tablet derived from praziquantel, the formulation used for older children and adults—is tailored to the needs of the estimated 50 million preschool-aged children suffering from schistosomiasis, who currently have no treatment option. Merck KGaA intends to apply for a scientific opinion from the European Medicines Agency under a high-priority procedure for medicines intended for markets outside the European Union, which would facilitate prequalification by the World Health Organization as well as regulatory approvals in endemic countries. 

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 Health Organization (WHO) last week issued an emergency use listing for the Covaxin COVID-19 vaccine, developed by Indian pharmaceutical company Bharat Biotech, making it the eighth vaccine to receive WHO authorization. Covaxin, which is formulated from an inactivated SARS-CoV-2 antigen, was found to be 78 percent effective against COVID-19 of any severity 14 or more days after the second dose. WHO review groups determined the vaccine meets standards for protection against COVID-19, with benefits far outweighing the risks, and recommended it be used in two doses with a dose interval of four weeks for people 18 and above. The WHO approval makes Covaxin eligible for distribution through the COVAX vaccine-sharing facility, and the vaccine’s easy storage requirements make it especially suited for global distribution.Merck’s oral COVID-19 treatment, molnupiravir, received approval from its first regulatory body Thursday when the UK Medicines and Healthcare products Regulatory Agency authorized its use for individuals with mild to moderate COVID-19 and at least one risk factor for developing severe illness. The treatment—the first antiviral medication for COVID-19 that can be taken as a pill rather than injected or given intravenously—cut the risk of hospitalization or death by about half in clinical trials. Given twice a day, starting within five days of symptoms developing to be most effective, the pill targets an enzyme that the virus uses to replicate, preventing it from multiplying—an approach that should make the treatment equally effective against new variants of the virus as it evolves, according to Merck.On Friday, Pfizer released results from a late-stage clinical trial of its antiviral pill to combat COVID-19 showing it to be highly effective at preventing severe illness among at-risk individuals who receive the drug shortly after the onset of symptoms. The pill cut the risk of hospitalization or death by 89 percent when given within three days of exhibiting symptoms, according to data from the trial, which an independent board of experts recommended be stopped early because the drug’s benefit to patients had proved so convincing. Pfizer plans to submit the data as soon as possible to the US Food and Drug Administration to seek authorization for the pill to be used in the United States.

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.Pharmaceutical company Merck has announced an agreement to share its license for the oral COVID-19 drug molnupiravir with the United Nations–backed Medicines Patent Pool to expand access to the treatment in more than 100 countries. Molnupiravir, an easy-to-take pill, reduced hospitalizations and deaths by half among higher-risk COVID-19 patients diagnosed with mild to moderate illness in a global clinical trial. The agreement is the first public health license for a COVID-19 treatment or vaccine, allowing the medicine to be produced by all capable manufacturers—once the drug receives regulatory approval—to expand the drug’s availability, widen its manufacturing base, and potentially push down the price. Merck has applied to the US Food and Drug Administration for emergency use authorization, and the European Medicines Agency recently began a rolling review of the drug.The Access to COVID-19 Tools Accelerator (ACT-A) on Thursday launched its new strategic plan outlining a focus on addressing access inequities to tools in underserved areas. Over the next year, ACT-A—a global partnership set up to accelerate the development and delivery of COVID-19 tests, treatments, and vaccines—will aim to support low- and middle-income countries in vaccinating 70 percent of their populations, increasing their testing rates to at least 1 per 1,000 people per day, and treating up to 120 million COVID-19 cases through deployment of existing treatments and enabling access to new therapies. The plan outlines a required budget of $23.4 billion between now and September 2022, including $840 million for research and development.Inexpensive drug fluvoxamine could reduce hospitalization in adults with severe COVID-19, according to research published Wednesday in The Lancet Global Health. The findings, based on a clinical trial in Brazil evaluating high-risk, symptomatic adults who had recently contracted COVID-19, showed participants were less likely to require hospitalization or an extended emergency room stay when given a 100-milligram dose of fluvoxamine twice daily for ten days. Fluvoxamine is commonly prescribed to treat depression and obsessive-compulsive disorder and is known to reduce inflammation, which COVID-19 can cause throughout the body. The study findings, part of the larger TOGETHER Trial aiming to identify repurposed therapies effective against COVID-19 disease progression, have been shared with the World Health Organization and the US National Institutes of Health.