Raul Rodriguez, Rigel CEO
Covid-19 roundup: Tiny sample size leads FDA to turn down Rigel's EUA; Seattle biotech to co-develop mRNA vaccine in South Korea
Four months after Rigel announced possible Phase II results for its Covid-19 treatment, the FDA has deemed the sample size too small and insufficient for an emergency use authorization, the company announced Friday.
The Phase II trial of fostamatinib, which has previously been approved by the FDA as a second-line therapy for thrombocytopenia, treated just 59 patients. Right now, a larger Phase III trial in hospitalized patients is underway to examine the efficacy of fostamatinib in hospitalized patients with mild-to-severe Covid-19 complications.
To read Endpoints News become a free subscriber
Unlock this article instantly, along with access to limited free monthly articles and our suite of newsletters