Approve leronlimab for EUA for mild/moderate patients

Approve leronlimab for EUA for mild/moderate patients

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J R started this petition to FDA Stephen Hahn FDA

Dear Dr. Hahn,

Leronlimab has completed a phase 2 trial for Covid mild/moderate patients and demonstrated strong efficacy including a statistically significant 250% improvement in the NEWS2 score (50% of patients improving vs. 20% placebo) and a over 60% reduction in severe adverse effects (with none of the SAE’s related to leronlimab)  It also has a strong safety record with over 1,000 patients having no serious adverse effects.

Leronlimab is ideal for the mild/moderate patient population as is administered only once a week over two weeks via subcutaneous injection.  This makes it perfect for outpatient and even on site applications such as nursing homes.  It has no exclusions for pre-existing conditions such as liver and kidney issues.  By preventing Covid from progressing to severe and critical it will save the lives of 1000’s

Leronlimab has three primary modes of action: quiets the cytokine storm, restores the immune system, and reduces viral load to zero over 14 days.  

As you saw through the public response, plasma is not seen as an effective treatment and remdesivir has a high side effect profile and does not demonstrate its primary mechanism of action of reducing the viral load.  In contrast, leronlimab has a proven mechanism of action that not only shows in patient outcomes but also in blood tests.  In fact, the length of treatment can be adjusted based on these tests.

We ask that you please give rapid EUA approval for this critical drug that can truly be a gamechanger in our fight against Covid at a time when it is needed most.

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At 2,500 signatures, this petition is more likely to get picked up by local news!