Humanigen Raises Chances of Lenzilumab EUA With Severe COVID-19 Data
Data on medRxiv showed a 90% improvement in likelihood of need for mechanical ventilation in the intent-to-treat population. The company plans a filing in Q2.
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The company is assessing a potential path forward in COVID-19 for the drug and is in talks with platform study groups after a Phase III study did not show statistical significance, but still showed activity.
The company plans to make a new EUA request prior to filing a BLA, but does not yet have a specific timeline. Meanwhile, it has been preparing for the drug’s distribution as a COVID-19 treatment.
While some cancer centers report sufficient stocks of the drug, they have already been turning to potential alternatives due to supply issues that could last for weeks or months.