FDA authorises Lilly's antibody therapy bamlanivimab for recently diagnosed COVID-19

Eli Lilly announced Monday that the FDA has granted its emergency-use authorisation (EUA) request for the investigational neutralising antibody bamlanivimab. The AbCellera-partnered therapy, also known as LY-CoV555, is authorised to treat recently diagnosed, mild-to-moderate COVID-19 in patients 12 years and older with a positive COVID-19 test, who are at high risk for progressing to severe COVID-19 and/or hospitalisation.

The FDA decision is based on data from the Phase II BLAZE-1 study in patients with recently diagnosed mild-to-moderate COVID-19 in the outpatient setting. Preliminary findings demonstrated that bamlanivimab led to reduced viral load, as well as rates of symptoms and hospitalisation. Daniel Skovronsky, chief scientific officer at Lilly, said the BLAZE-1 data suggest that "when given early in the disease course, [bamlanivimab] may help patients clear the virus and reduce COVID-related hospitalisations, supporting our belief that neutralising antibodies can be an important therapeutic option for patients fighting this virus."

Shipping immediately

Lilly noted that bamlanivimab, which is administered via a single intravenous infusion, should be given as soon as possible after a positive COVID-19 test, and within 10 days of symptom onset. The EUA includes a warning for hypersensitivity, including anaphylaxis and infusion-related reactions. Lilly recently signed a $375-million contract to supply the US government with 300,000 vials of the treatment, and the company said it will begin shipping bamlanivimab immediately to AmerisourceBergen, which will distribute it as directed by the US government's allocation programme.

In October, scientists at the US National Institute of Allergy and Infectious Diseases said that no more hospitalised patients with COVID-19 enrolled in the ACTIV-3 study would be receiving bamlanivimab, after that trial's independent monitoring board suggested the monoclonal antibody was unlikely to be of clinical value in this population. However, the ongoing ACTIV-2 study evaluating bamlanivimab among outpatients continues to enrol patients.

The FDA is also currently reviewing an EUA submission for Regeneron Pharmaceuticals' REGN-COV2, a combination of two monoclonal antibodies, in adults with mild-to-moderate COVID-19 who are at high risk for poor outcomes. Regeneron recently paused enrolling hospitalised COVID-19 patients with high oxygen needs in its REGN-COV2 trials on the advice of an independent data monitoring committee, citing "a potential safety signal and an unfavourable risk/benefit profile at this time." For related analysis, see ViewPoints: Regeneron's mAb wobbles highlight importance of bispecifics.

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