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The US FDA has approved ziresovir (AK0529) for a P-II trial in the severely ill RSV infected infant patients, including those in the pediatric intensive care unit (PICU)
The trial will compare ziresovir with PBO to evaluate clinical efficacy, particularly oxygen-treatment duration & sustained recovery time, generating data to support future registrational trials
In a Chinese study on pts aged 1–24 mos., ziresovir significantly reduced viral load, accelerated respiratory symptom resolution, & lowered the risk of recurrent wheezing and asthma over 24 mos. Findings were published in The NEJM & The Lancet Child & Adolescent Health
Ref: PRnewswire | Image: ArkBio | Press Release
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The post ArkBio’s Ziresovir Secures the US FDA Approval for P-II Trial in RSV Infant Patients appeared first on PharmaShots.
ArkBio’s Ziresovir Secures the US FDA Approval for P-II Trial in RSV Infant Patients | PharmaVoice