Lilly’s Bamlanivimab (LY-CoV555) Receives FDA Emergency Use Authorization: A First COVID-19 Patients at High Risk
NOV 11, 2020 | COVID-19, EMERGENCY USE AUTHORIZATION, FDA, LY-COV555, MONOCLONAL ANTIBODY, NEWS
Lilly’s Bamlanivimab (LY-CoV555) Receives FDA Emergency Use Authorization A First COVID-19 Patients at High Risk
The U.S. Food and Drug Administration (FDA) today granted the first Emergency Use Authorization (EUA) for a monoclonal antibody targeting SARS-CoV-2, the virus behind COVID-19. Namely, bamlanivimab (LY-CoV555), an investigational neutralizing antibody developed by Eli Lilly and Company’s (NYSE: LLY) is now 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. Lilly has smartly tested this investigational product for those at high risk at early onset of the infection. Importantly, an EUA doesn’t mean an approval. Lilly doesn’t know if this drug is ultimately safe and effective for treatment of COVID-19: its still an investigational product. Based on a previous TrialSite report, this authorization triggers a deal worth up to $12.5 billion for Eli Lilly. TrialSite posits that National Institutes of Health should still be investigating low cost, effective treatments, especially for those high risk patients recently diagnosed with COVID-19.
TrialSite News offers a brief breakdown of this latest FDA action.
Why is this a breakthrough EUA?
Because there has been absolutely no FDA authorized (whether formally registered or EUA) treatment for early stage onset of COVID-19. To date, when an individual tests positive for COVID-19 but has mild to moderate symptoms they are typically sent home and told to rest and monitor the condition. This unfortunately is problematic according to many physicians. Now there is an emergency authorized treatment for this early stage in those that are considered high risk. It’s important to note however that Lilly explicitly reminds that bamlanivimab is still investigational, meaning they don’t know if it treats COVID-19 effectively and safely. See the FDA’s letter here.
Daniel Skovronsky, M.D., Ph.D., Lilly’s chief scientific officer and president of Lilly Research Laboratories commented on the action “The BLAZE-1 data show bamlanivimab, when given early in the disease course, may help patients clear the virus and reduce COVID-related hospitalizations, supporting our belief that neutralizing antibodies can be an important therapeutic option for patients fighting this virus.” The Lilly executive continued “We’re proud of the speed with which we have been able to bring patients this therapy specifically designed to treat COVID-19. We thank those who have contributed to this medical advancement, particularly the clinical trial investigators and participants around the country.”
Who benefits from this EUA?
Potentially those individuals that have been diagnosed with SARS-CoV-2 that are deemed high risk, for example the elderly, or someone with obesity issues, or other comorbidities. Their physicians can now potentially administer this powerful monoclonal antibody therapy.
What is the basis for the EUA?
The BLAZE-1 clinical trial paved the way for this EUA. The randomized, double-blind, placebo-controlled Phase 2 study in patients with recently diagnosed mild to moderate COVID-19 in the outpatient setting. Patients treated with bamlanivimab showed reduced viral load and rates of symptoms and hospitalization.
In BLAZE-1, frequency and types of adverse events were similar between bamlanivimab and placebo, with the majority being mild to moderate in severity. Infusion reactions and other allergic hypersensitivity events have been reported. The EUA includes a warning for hypersensitivity including anaphylaxis and infusion-related reactions.
Is the EUA the same as an FDA Approval?
No. Bamlanivimab has not been approved by the FDA for any use. It is not known if bamlanivimab is safe and effective for the treatment of COVID-19.
Bamlanivimab is authorized under an Emergency Use Authorization only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of bamlanivimab under Section 564(b)(1) of the Act, 21 U.S.C § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
The FDA grants emergency use authorization to provide availability of a medicine that may help diagnose, treat or prevent a life-threatening disease when no adequate and approved alternatives are available.
This use of bamlanivimab is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use, unless the authorization is terminated or revoked sooner. The authorization is temporary and does not replace the formal review and approval process. Bamlanivimab remains an investigational drug and has not been approved under a Biologics License Application (BLA). Evaluation of its safety and efficacy is ongoing across a range of patient populations impacted by COVID-19. Data from these studies will be used to support a future BLA submission involving bamlanivimab.
What are the logistics of the EUA? How does it work?
Lilly is now authorized under this EUA to manufacture the investigational product specifically for the purposes of treating individuals considered high risk who have been recently diagnosed with COVID-19. Now doctors will have access to this investigational therapy.
Lilly will begin shipping bamlanivimab immediately to AmerisourceBergen, a national distributor, which will distribute it as directed by the U.S. government’s allocation program. For the most up-to-date information regarding access to bamlanivimab, Lilly suggests in their press release that patients should speak with their health care providers, and health care providers should contact their state health department directly.
What is the cost of this drug?
Lilly has pointed out in their press release that the U.S. government has purchased 300,000 doses of bamlanivimab and committed that Americans will have no out-of-pocket costs for the medicine, although healthcare facilities may charge a fee for the product’s administration.
TrialSite already reported that this totaled $12.5 billion—an unprecedented drug deal. Of course, this cost is ultimately absorbed by the taxpayer and additional health provider fees may add up to a substantial amount. TrialSite will be monitoring this carefully.
Will the federal government be responsible for the allocation of this investigational drug?
Yes. The federal government is responsible for the appropriate allocation of bamlanivimab. Weekly allocation decisions will be proportionally based on confirmed COVID-19 cases in each state and territory over the previous seven days, based on data from the U.S. Department of Health and Human Services’ Protect data collection platform. Each week, state and territorial health departments will select sites of care (that are accessible and can minimize infection transmission) to receive allocated doses and will provide AmerisourceBergen the list of sites. Sites of care will then confirm their need and AmerisourceBergen will distribute bamlanivimab overnight.
What is the manufacturing effort involved?
Lilly has been making considerable investments in manufacturing capacity at risk. This is one reason why they have pegged product price at $12,500 per dose for the EUA. Lilly sought, again at risk, that the product production could be ready for rapid access of this treatment to patients around the world. Lilly reminds all in their recent press release that they have maintained a robust, global supply chain in place to produce bamlanivimab, with numerous manufacturing sites worldwide.
Lilly anticipates manufacturing up to one million doses of bamlanivimab 700 mg by the end of 2020, for use around the world through early next year. Beginning in Q1 2021, the supply of Lilly’s antibody therapy is expected to increase substantially, as additional manufacturing resources come online throughout the year.
Is the product authorized on an emergency basis anywhere else?
No not yet. However, the Indianapolis-based pharmaceutical company is in discussions with global regulators to make bamlanivimab available around the world. Global allocation will be made based on Lilly’s guiding principles that aim to ensure access for patients with high unmet needs, no matter where they live.
About the Investigational Product
Bamlanivimab is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. It is designed to block viral attachment and entry into human cells, thus neutralizing the virus, potentially treating COVID-19. Bamlanivimab emerged from the collaboration between Lilly and AbCellera to create antibody therapies for the prevention and treatment of COVID-19. Lilly scientists rapidly developed the antibody in less than three months after it was discovered by AbCellera (University of British Columbia spinoff) and the scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center. It was identified from a blood sample taken from one of the first U.S. patients who recovered from COVID-19.
Lilly has successfully completed a Phase 1 study of bamlanivimab in hospitalized patients with COVID-19 (NCT04411628). A Phase 2 study in people recently diagnosed with COVID-19 in the ambulatory setting (BLAZE-1, NCT04427501) is ongoing. A Phase 3 study of bamlanivimab for the prevention of COVID-19 in residents and staff at long-term care facilities (BLAZE-2, NCT04497987) is also ongoing. In addition, bamlanivimab is being tested in the National Institutes of Health-led ACTIV-2 study in ambulatory COVID-19 patients.
Are there risks with this investigational product?
Absolutely. There is very limited amounts of clinical data and serious and unexpected adverse events may occur that have not been previously reported with use of bamlanivimab. Risks include hypersensitivity including anaphylaxis and infusion-related reactions. Moreover, one of the clinical trials involving this investigational product was paused. Moreover the drug poses potential greater risk to hospitalized patients. See FDA letter for more details.
Call to Action: See Lilly’s press release as well as FDA letter. For those seeking more information about bamlanivimab in COVID-19, contact Lilly’s 24-hour support line at 1-855-LillyC19 (1-855-545-5921).
NOV 11, 2020 | COVID-19, EMERGENCY USE AUTHORIZATION, FDA, LY-COV555, MONOCLONAL ANTIBODY, NEWS
Lilly’s Bamlanivimab (LY-CoV555) Receives FDA Emergency Use Authorization A First COVID-19 Patients at High Risk
The U.S. Food and Drug Administration (FDA) today granted the first Emergency Use Authorization (EUA) for a monoclonal antibody targeting SARS-CoV-2, the virus behind COVID-19. Namely, bamlanivimab (LY-CoV555), an investigational neutralizing antibody developed by Eli Lilly and Company’s (NYSE: LLY) is now 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. Lilly has smartly tested this investigational product for those at high risk at early onset of the infection. Importantly, an EUA doesn’t mean an approval. Lilly doesn’t know if this drug is ultimately safe and effective for treatment of COVID-19: its still an investigational product. Based on a previous TrialSite report, this authorization triggers a deal worth up to $12.5 billion for Eli Lilly. TrialSite posits that National Institutes of Health should still be investigating low cost, effective treatments, especially for those high risk patients recently diagnosed with COVID-19.
TrialSite News offers a brief breakdown of this latest FDA action.
Why is this a breakthrough EUA?
Because there has been absolutely no FDA authorized (whether formally registered or EUA) treatment for early stage onset of COVID-19. To date, when an individual tests positive for COVID-19 but has mild to moderate symptoms they are typically sent home and told to rest and monitor the condition. This unfortunately is problematic according to many physicians. Now there is an emergency authorized treatment for this early stage in those that are considered high risk. It’s important to note however that Lilly explicitly reminds that bamlanivimab is still investigational, meaning they don’t know if it treats COVID-19 effectively and safely. See the FDA’s letter here.
Daniel Skovronsky, M.D., Ph.D., Lilly’s chief scientific officer and president of Lilly Research Laboratories commented on the action “The BLAZE-1 data show bamlanivimab, when given early in the disease course, may help patients clear the virus and reduce COVID-related hospitalizations, supporting our belief that neutralizing antibodies can be an important therapeutic option for patients fighting this virus.” The Lilly executive continued “We’re proud of the speed with which we have been able to bring patients this therapy specifically designed to treat COVID-19. We thank those who have contributed to this medical advancement, particularly the clinical trial investigators and participants around the country.”
Who benefits from this EUA?
Potentially those individuals that have been diagnosed with SARS-CoV-2 that are deemed high risk, for example the elderly, or someone with obesity issues, or other comorbidities. Their physicians can now potentially administer this powerful monoclonal antibody therapy.
What is the basis for the EUA?
The BLAZE-1 clinical trial paved the way for this EUA. The randomized, double-blind, placebo-controlled Phase 2 study in patients with recently diagnosed mild to moderate COVID-19 in the outpatient setting. Patients treated with bamlanivimab showed reduced viral load and rates of symptoms and hospitalization.
In BLAZE-1, frequency and types of adverse events were similar between bamlanivimab and placebo, with the majority being mild to moderate in severity. Infusion reactions and other allergic hypersensitivity events have been reported. The EUA includes a warning for hypersensitivity including anaphylaxis and infusion-related reactions.
Is the EUA the same as an FDA Approval?
No. Bamlanivimab has not been approved by the FDA for any use. It is not known if bamlanivimab is safe and effective for the treatment of COVID-19.
Bamlanivimab is authorized under an Emergency Use Authorization only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of bamlanivimab under Section 564(b)(1) of the Act, 21 U.S.C § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
The FDA grants emergency use authorization to provide availability of a medicine that may help diagnose, treat or prevent a life-threatening disease when no adequate and approved alternatives are available.
This use of bamlanivimab is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use, unless the authorization is terminated or revoked sooner. The authorization is temporary and does not replace the formal review and approval process. Bamlanivimab remains an investigational drug and has not been approved under a Biologics License Application (BLA). Evaluation of its safety and efficacy is ongoing across a range of patient populations impacted by COVID-19. Data from these studies will be used to support a future BLA submission involving bamlanivimab.
What are the logistics of the EUA? How does it work?
Lilly is now authorized under this EUA to manufacture the investigational product specifically for the purposes of treating individuals considered high risk who have been recently diagnosed with COVID-19. Now doctors will have access to this investigational therapy.
Lilly will begin shipping bamlanivimab immediately to AmerisourceBergen, a national distributor, which will distribute it as directed by the U.S. government’s allocation program. For the most up-to-date information regarding access to bamlanivimab, Lilly suggests in their press release that patients should speak with their health care providers, and health care providers should contact their state health department directly.
What is the cost of this drug?
Lilly has pointed out in their press release that the U.S. government has purchased 300,000 doses of bamlanivimab and committed that Americans will have no out-of-pocket costs for the medicine, although healthcare facilities may charge a fee for the product’s administration.
TrialSite already reported that this totaled $12.5 billion—an unprecedented drug deal. Of course, this cost is ultimately absorbed by the taxpayer and additional health provider fees may add up to a substantial amount. TrialSite will be monitoring this carefully.
Will the federal government be responsible for the allocation of this investigational drug?
Yes. The federal government is responsible for the appropriate allocation of bamlanivimab. Weekly allocation decisions will be proportionally based on confirmed COVID-19 cases in each state and territory over the previous seven days, based on data from the U.S. Department of Health and Human Services’ Protect data collection platform. Each week, state and territorial health departments will select sites of care (that are accessible and can minimize infection transmission) to receive allocated doses and will provide AmerisourceBergen the list of sites. Sites of care will then confirm their need and AmerisourceBergen will distribute bamlanivimab overnight.
What is the manufacturing effort involved?
Lilly has been making considerable investments in manufacturing capacity at risk. This is one reason why they have pegged product price at $12,500 per dose for the EUA. Lilly sought, again at risk, that the product production could be ready for rapid access of this treatment to patients around the world. Lilly reminds all in their recent press release that they have maintained a robust, global supply chain in place to produce bamlanivimab, with numerous manufacturing sites worldwide.
Lilly anticipates manufacturing up to one million doses of bamlanivimab 700 mg by the end of 2020, for use around the world through early next year. Beginning in Q1 2021, the supply of Lilly’s antibody therapy is expected to increase substantially, as additional manufacturing resources come online throughout the year.
Is the product authorized on an emergency basis anywhere else?
No not yet. However, the Indianapolis-based pharmaceutical company is in discussions with global regulators to make bamlanivimab available around the world. Global allocation will be made based on Lilly’s guiding principles that aim to ensure access for patients with high unmet needs, no matter where they live.
About the Investigational Product
Bamlanivimab is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. It is designed to block viral attachment and entry into human cells, thus neutralizing the virus, potentially treating COVID-19. Bamlanivimab emerged from the collaboration between Lilly and AbCellera to create antibody therapies for the prevention and treatment of COVID-19. Lilly scientists rapidly developed the antibody in less than three months after it was discovered by AbCellera (University of British Columbia spinoff) and the scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center. It was identified from a blood sample taken from one of the first U.S. patients who recovered from COVID-19.
Lilly has successfully completed a Phase 1 study of bamlanivimab in hospitalized patients with COVID-19 (NCT04411628). A Phase 2 study in people recently diagnosed with COVID-19 in the ambulatory setting (BLAZE-1, NCT04427501) is ongoing. A Phase 3 study of bamlanivimab for the prevention of COVID-19 in residents and staff at long-term care facilities (BLAZE-2, NCT04497987) is also ongoing. In addition, bamlanivimab is being tested in the National Institutes of Health-led ACTIV-2 study in ambulatory COVID-19 patients.
Are there risks with this investigational product?
Absolutely. There is very limited amounts of clinical data and serious and unexpected adverse events may occur that have not been previously reported with use of bamlanivimab. Risks include hypersensitivity including anaphylaxis and infusion-related reactions. Moreover, one of the clinical trials involving this investigational product was paused. Moreover the drug poses potential greater risk to hospitalized patients. See FDA letter for more details.
Call to Action: See Lilly’s press release as well as FDA letter. For those seeking more information about bamlanivimab in COVID-19, contact Lilly’s 24-hour support line at 1-855-LillyC19 (1-855-545-5921).
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