FDA declines Rigel Pharma's EUA for COVID indications

Aug. 13, 2021

The U.S. FDA has declined to issue emergency use authorization for Rigel Pharmaceuticals' drug for the treatment of COVID-19 in hospitalized adults, citing insufficient clinical data.

Specifically, the agency referred to the clinical data submitted in late-May from a 59-patient NIH/NHLBI-sponsored phase 2 trial of Rigel's Tavalisse (fostamatinib) to treat patients hospitalized with COVID-19.

Tavalisse tablets are the California-based biotech's first FDA approved product and the only oral spleen tyrosine kinase (SYK) inhibitor for the treatment of adult patients with chronic immune thrombocytopenia, an autoimmune disorder, who have had an insufficient response to a previous treatment.

In terms of obtaining an EUA, Rigel says it is currently conducting a larger phase 3 clinical trial evaluating Tavalisse in hospitalized patients and anticipate completing it later this year. According to the company, if the trial meets endpoints, Rigel will resubmit its EUA application with the additional data.

Read the press release