Eli Lilly Reports Results of Bamlanivimab (LY-CoV555) in P-III BLAZE-2 Study for Preventing COVID-19 at Nursing Homes

Shots:

  • The P-III BLAZE-2 COVID-19 prevention trial involves assessing bamlanivimab (4,200mg) vs PBO in residents and staff at skilled nursing and assisted living facilities. The 965 &132 COVID-19 negative & positive participants were included in the analysis of 1EPS & 2EPs for assessing prevention & in exploratory analyses respectively
  • The results demonstrated an 80% reduction in risk of contracting COVID-19 in residents. Results for all 2EPs also reached statistical significance in both the overall and resident populations
  • Results from the exploratory analyses showed viral load is consistent with the previous studies

Click here ­to­ read full press release/ article | Ref: Lilly | Image: Reuters

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Lilly’s Bamlanivimab (LY-CoV555) Receives Health Canada’s Interim Authorization as a Treatment for COVID-19

Shots:

  • The authorization is based on P-II BLAZE-1 study assessing the efficacy and safety of bamlanivimab (700/2800/7000 mg) alone or in combination with a second Ab vs PBO for the treatment of symptomatic COVID-19 in the outpatient setting
  • Results: reduction in viral load & rates of symptoms & hospitalization, frequency & types of AEs are similar
  • Health Canada authorized the therapy for the use of bamlanivimab (LY-CoV555) as a treatment for adults & pediatric patients aged≥12yrs. with mild to mod. COVID-19 who weigh at least 40 kg & are at high risk of progressing to severe COVID-19 illness or hospitalization

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Microbioz India

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Lilly to ship COVID-19 drug straight away after FDA green light

Eli Lilly has said it will start shipping supplies of its COVID-19 drug bamlanivimab immediately, after claiming emergency-use authorisation (EUA) for the antibody.

The AbCellera-partnered drug, previously known as LY-CoV555 or LY3819253, can be used to treat mild-to-moderate COVID-19 in patients 12 years and older, who are at high risk for progressing to severe disease that might require hospitalisation.

President Trump has previously pledged to make antibody drugs available for free to anyone who needs them, and his administration has already signed a $375 million contract with Lilly to supply 300,000 doses of the drug within two weeks of the EUA.

The US has also taken an option on another 650,000 doses of the drug between now and the end of June 2021.

Lilly chief executive David Ricks has also said that patients should have no out-of-pocket costs for the drug, although healthcare facilities may charge a fee for the antibody’s intravenous administration.

The EUA as well as the US government contract came despite the results of the ACTIV-3 trial run by the National Institute of Allergy and Infectious Diseases (NIAID), which halted enrolment in the bamlanivimab arm because data to date suggested the drug was unlikely to be effective in hospitalised patients.

The FDA approved a 700mg single IV dose of the drug based on the phase 2 BLAZE-1 trial, which showed a reduced rate of hospitalisation in patients at high risk of COVID-19 progression who were treated with the antibody in the outpatient setting.

The NIAID is also running another study of Lilly’s antibody, ACTIV-2, which involves outpatients with mild-to-moderate COVID-19 symptoms.

Lilly says it will ship supplies of the drug to AmerisourceBergen, which will handle distribution once a week in accordance with the US government’s allocation plans. Where the drug is distributed will depend on confirmed COVID-19 cases across the US over the prior seven days.

Bamlanivimab – an antibody that neutralises the SARS-CoV-2 coronavirus – joins Gilead’s antiviral Veklury (remdesivir) on the list of drugs with EUAs for COVID-19, but is the first to be cleared for use outside hospitals.

Veklury’s EUA and subsequent full approval by the FDA covers the treatment of patients with COVID-19 who already require hospitalisation. The FDA has also issued EUAs for convalescent plasma for hospitalised patients, as well as for certain drugs that don’t target the virus directly but are used to support patients whilst in acute care.

Lilly notes that bamlanivimab should be administered as soon as possible after a positive COVID-19 test and within 10 days of symptom onset.

The company says it hopes to be able to produce up to one million doses of bamlanivimab 700mg by the end of 2020, “for use around the world through early next year.”

The FDA is meanwhile reviewing an EUA for Regeneron’s COVID-19 antibody therapy REGN-COV2, focusing on patients with mild to moderate disease who are at risk of progressing, and a decision on that could be made shortly.

REGN-COV2 also seems at risk of falling short in hospitalised patients, after a safety concern led to the pause of enrolment in a clinical trial in this setting earlier this month.

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Lilly’s Bamlanivimab (LY-CoV555) Receives the US FDA’s EUA for the Treatment of Recently Diagnosed COVID-19

Shots:

  • The EUA is based on P-II BLAZE-1 study assessing bamlanivimab (700/2800/7000 mg) as monothx. vs PBO or in combination with second Ab for the treatment of symptomatic COVID-19 in the outpatient setting. The EUA is granted for bamlanivimab (LY-CoV555, 700 mg)
  • Patients showed reduced viral load & rates of symptoms & hospitalization. The EUA includes a warning for hypersensitivity including anaphylaxis and infusion-related reactions
  • The US government will allocate 300,000 doses of bamlanivimab to high-risk patients, with no out-of-pocket costs for the medication. Bamlanivimab should be administered asap after a positive COVID-19 test and within 10 days of symptom onset

Click here ­to­ read full press release/ article | Ref: Eli Lilly | Image: Business Standard

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Lilly Reports Results of Bamlanivimab (LY-CoV555) in P-II BLAZE-1 Study in New England Journal of Medicine

Shots:

  • The P-II BLAZE-1 study assesses bamlanivimab (700, 2800 & 7000 mg) vs PBO in the outpatient setting in patients with mild or moderate symptoms of COVID-19 as well as a positive SARS-CoV-2 test based on a sample collected no more than 3 days prior to drug infusion
  • Results: The study showed that bamlanivimab may be effective in treating COVID-19 by reducing viral load, symptoms and the risk of hospitalization in patients recently diagnosed with mild to moderate COVID-19
  • LY-CoV555 is a neutralizing IgG1 mAb directed against the spike protein of SARS-CoV-2 & designed to block viral attachment and entry into human cells, thus neutralizing the virus, potentially preventing & treating COVID-19

Click here to­ read full press release/ article | Ref: PRNewswire | Image: Business Insider

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US buys Lilly COVID antibody, as effectiveness questions remain

The US government said it will buy 300,000 doses of Eli Lilly’s COVID-19 therapy bamlanivimab for $375 million if the drug gets Emergency Use Authorisation (EUA) – despite the fact its effectiveness has been called into question.

The initial agreement is for delivery over the two months following an EUA, and provides the option for the government to purchase up to an additional 650,000 vials through 30 June 2021.

Lilly filed for emergency use authorisation (EUA) of bamlanivimab for the treatment of recently diagnosed mild to moderate COVID-19 illness in high-risk patients in early October.

The US has said that patients will have no out-of-pocket costs for the medicine – echoing a promise by Lilly CEO Dave Ricks – although healthcare facilities may charge a fee for the product’s administration. 

The federal government, in partnership with state health departments, is developing a government allocation program for bamlanivimab.

Ricks has said that the company “must work with global health systems to ensure equitable access to our medicine at a fair price”.

“Our goal is to ensure that Lilly antibody treatments are available to patients who need them, no matter where they live.

“As long as supply of neutralising antibodies is constrained, we believe the only way to ensure equitable access is for Lilly to contract directly with governments and pan-national philanthropic organisations. These institutions are best positioned to direct our antibody treatments to the patients who need them most.”

He added that treatment allocation will be based on unmet medical needs globally and that  equitable government pricing will be tiered based on a country’s ability to pay.

But the news might be dampened somewhat by this week’s announcement that no more patients will be treated with bamlanivimab in a trial run by the National Institute of Allergy and Infectious Diseases (NIAID), as results to date suggest it is unlikely to be effective.

The ACTIV-3 study was comparing bamlanivimab (also known as LY-CoV555 or LY3819253) and placebo when added to therapy with Gilead Sciences’ Veklury (remdesivir), which is already approved to treat COVID-19 requiring hospitalisation.

According to Lilly, the NIAID took its decision on the strength of trial data  which indicated that bamlanivimab – an antibody that neutralises the SARS-CoV-2 coronavirus – was unlikely to help hospitalised patients recover from advanced-stage COVID-19.

The drugmaker stressed however that other trials of its drug in COVID-19 are still continuing, and it pointed out that the earlier BLAZE-1 study of bamlanivimab showed a reduced rate of hospitalisation in patients treated with the antibody in the outpatient setting.

It also said it “remains confident…that bamlanivimab monotherapy may prevent progression of disease for those earlier in the course of COVID-19.

ACTIV-3 is a substudy of a larger, 10,000-patient trial that is putting a series of COVID-19 drugs through their paces, and Lilly’s drug is the only arm to include an antibody targeting SARS-CoV-2. In each case, 300 patients are enrolled initially before a decision is taken whether to expand the trial to 1,000 subjects.

In a statement, the NIAID said enrolment of patients into the bamlanivimab was paused on 13 October after 326 had been recruited, “out of an abundance of caution”, and terminated on 26 October.

There were no safety issues – the decision was “driven by lack of clinical benefit for LY-CoV555,” according to the agency – and the patients will continue to be followed for 90 days’ follow-up.

The NIAID is also running another study of Lilly’s antibody, ACTIV-2, which involves outpatients with mild-to-moderate COVID-19 symptoms, and that is continuing as planned.

BLAZE-1 is also continuing – looking at bamlanivimab alone and in combination with etesevimab (LY-CoV016) another Lilly antibody targeting SARS-CoV-2 – and the company is also running the BLAZE-2 trial of bamlanivimab as prophylaxis against COVID-19 in nursing home residents and staff.

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Lilly seeks emergency clearance for Covid-19 monoclonal antibodies on Phase II data

The company announced data on the combination of two antibodies against the SARS-CoV-2 virus, showing significant reductions in viral load compared with placebo. The company has applied for an EUA for LY-CoV555 and will seek an authorization for the combination of that drug with LY-CoV016 next month.