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Ridgewood NJ, Eli Lilly, the pharmaceutical giant, launched a direct-to-consumer website yesterday, providing its customers with the option to obtain third-party prescriptions for its medications, including the newly approved weight loss injectable Zepbound (similar to Novo Nordisk’s Wegovy/Ozempic). Through the site, users can connect to a telehealth service, enabling them to quickly receive prescriptions before making a purchase.
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Ridgewood NJ, according to Johns Hopkins Center for Health Security on February 9, the US FDA issued an Emergency Use Authorization (EUA) for Eli Lilly’s monoclonal antibody cocktail of bamlanivimab and etesevimab as a treatment for COVID-19. The EUA specifically authorizes the treatment for “mild to moderate” COVID-19 in adults and pediatric patients aged 12 years and older who are “at high risk for progressing to severe” disease.
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INDIANAPOLIS IN, The U.S. Food and Drug Administration (FDA) today granted Emergency Use Authorization (EUA) for Eli Lilly and Company’s (NYSE: LLY) investigational neutralizing antibody bamlanivimab (LY-CoV555) 700 mg. Bamlanivimab is authorized for the treatment of mild to moderate COVID-19 in adults and pediatric patients 12 years and older with a positive COVID-19 test, who are at high risk for progressing to severe COVID-19 and/or hospitalization. Bamlanivimab should be administered as soon as possible after a positive COVID-19 test and within 10 days of symptom onset. The authorization allows for the distribution and emergency use of bamlanivimab, which is administered via a single intravenous infusion.
Continue reading ELI LILLY monoclonal antibody treatment for COVID Shows Promise
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Ridgewood NJ, according to Johns Hopkins Center for Health Security ,Pharmaceutical manufacturer Eli Lilly submitted an EUA request to the FDA for its monoclonal antibody cocktail as a COVID-19 treatment after clinical trials for the drugs met the target clinical endpoints. Results from a Phase 2 clinical trial indicate that a combination of two of Eli Lilly’s monoclonal antibodies reduced viral load in COVID-19 patients mitigated symptoms and resulted in fewer hospitalizations and emergency department visits. The study included 268 total participants with mild-to-moderate COVID-19 symptoms, 112 of whom received the treatment and 156 who received a placebo. Additionally, a press release issued by the company indicates that no serious adverse events were reported. The company stated that it aims to make 100,000 doses of a single antibody available by the end of October and 1 million by the end of 2020. For the combination therapy, the company hopes to produce 50,000 doses by the end of 2020, and it is collaborating with various external partners to ensure availability for lower-income countries.
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Ridgewood NJ, Pharmaceutical manufacturer Eli Lilly commenced early stage human trials of a monoclonal antibody therapeutic for COVID-19, marking the first trial of a treatment developed specifically for COVID-19. The Phase 1 clinical trial of LY-CoV555, an antibody treatment created from a blood sample of early US COVID-19 survivors, will test the drug’s safety in 32 patients who are currently hospitalized for COVID-19. Results of the trial are expected to be available later this month in order to determine if the treatment can continue to a larger trial testing efficacy and safety in non-hospitalized patients. Eli Lilly is already working to scale up production, with the aim of making the drug available as early as this fall, if it is demonstrated to be safe and effective. In addition to these trials, Eli Lilly plans to test other antibody therapies, and combinations of antibodies, as both treatment and prevention against SARS-CoV-2 infection