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news.The U.S. Food and Drug Administration (FDA) has approved Emergency Use Authorization (EUA) for investigational bamlanivimab and etesevimab as a combination therapy for the treatment of mild to moderate Covid-19 patients.
The EUA is based on the BLAZE-1 trial Phase 3 data announced on 26 January 2021. Credit: Tumisu from Pixabay
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The U.S. Food and Drug Administration (FDA) has approved Emergency Use Authorization (EUA) for investigational bamlanivimab and etesevimab as a combination therapy for the treatment of mild to moderate Covid-19 patients.
The patients however need to be aged 12 years or above and at high risk of contracting severe Covid-19 and/or hospitalisation.
Both products of the R&D centres of the 144-year-old global healthcare leader Eli Lilly, bamlanivimab (LY-CoV555) 700 mg and etesevimab (LY-CoV016) 1400 mg are to be used together to treat Covid-19, announced Lilly.
The administration of both the recombinant neutralising antibodies is to be made simultaneously through a single intravenous infusion, soon after a positive Covid-19 test and within 10 days of experiencing the symptoms.
Apart from this, the USFDA has also authorised a 16-minute infusion time limit for bamlanivimab alone or a 21-minute infusion time for bamlanivimab and etesevimab together.
Earlier the infusion time for Covid-19 treatment drugs was 60 minutes. The change in decision reflects the feedback made by front-line nurses and doctors and aim to lighten the burden on the already overtaxed healthcare system.
Lilly Research Laboratories president and chief scientific officer Daniel Skovronsky said: “Lilly has dedicated our time, resources, and expertise to discover and develop therapies to treat Covid-19. Bamlanivimab alone under emergency use authorisation has already provided many people with an early treatment option that could prevent hospitalisations and we are excited to now add an additional therapeutic option with a similar demonstrated clinical benefit.
“Additionally, with the risk of resistance emerging as various strains of the virus arise, bamlanivimab and etesevimab together could potentially allow efficacy against a broader range of naturally occurring SARS-CoV-2 variants as these new strains spread around the world.”
The EUA is based on the BLAZE-1 trial Phase 3 data announced on 26 January 2021, which demonstrated successful use of bamlanivimab and etesevimab together by reducing the risk of Covid-19 hospitalisations and even death by 70%. These data reflect previous results published in The Journal of the American Medical Association.
The USFDA approves EUA to a medicine which may assist in the diagnosis, treatment or prevention of a life-threatening disease when no other alternatives are available.
While several countries have authorised the use of bamlanivimab, the US and Italy are the only countries to currently authorise the bamlanivimab-etesevimab combo.
Collaborating with Amgen, Lilly plans to generate a consignment of about one million doses of etesevimab to be combined with bamlanivimab by mid-2021. With 100,000 doses immediately available, the first quarter will see the addition of 150,000 more doses.
However, bamlanivimab and etesevimab are not authorised to be used for patients hospitalised due to Covid-19 and those who require oxygen therapy due to Covid-19 or other underlying non-Covid-19 related comorbidities.