BIOVF - Sobi wins FDA nod for COVID-19 therapy

• Swedish Orphan Biovitrum AB ( OTCPK:BIOVF ), the biotech also known as Sobi, has received the FDA’s Emergency Use Authorization (EUA) for its anti-inflammatory medication Kineret as a treatment for certain hospitalized patients with COVID-19.
• The FDA decision was backed by data from a pivotal Phase 3 clinical trial involving more than 600 patients with COVID-19 pneumonia who were at risk of developing severe respiratory failure.
• Kineret, already approved in the U.S. for conditions including rheumatoid arthritis, is an Interleukin-1 (IL-1) receptor antagonist. IL-1 is linked to inflammatory diseases, including acute lung inflammation in COVID-19.
• According to the FDA, Kineret injection will only be limited for use in hospitalized adults with COVID-19 pneumonia requiring supplemental oxygen and who are at risk of developing severe respiratory failure.
• The authorization comes ahead of an FDA AdCom meeting scheduled for Wednesday to discuss the EUA filed by Veru ( VERU ) for its oral COVID-19 therapy, sabizabulin.

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