InflaRx Report EMA’s Validation of MAA for Vilobelimab to Treat Critically Ill COVID-19 Patients
Shots:
- The EMA has validated the MAA for Vilobelimab to treat critically ill COVID-19 patients. The application is now under regulatory review by CHMP under the centralized procedure which valid to all 27 member states of the EU
- The submission was based on the P-III trial (PANAMO) trial evaluating vilobelimab in invasively mechanically ventilated COVID-19 patients in intensive care units which showed that vilobelimab improved survival with a relative reduction in 28-day all-cause mortality of 23.9%
- The results were published in The Lancet Respiratory Medicine. The company continues to discuss with the US FDA related to the submission of a BLA for full approval of Gohibic (vilobelimab)
Ref: Globenewswire | Image: inflarx
Related News:- InflaRx Receives the US FDA’s EUA for Gohibic (vilobelimab) to Treat COVID-19
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
