Shots:

• The US FDA has granted ODD for Kiniksa’s Rilonacept to treat pericarditis- which includes recurrent pericarditis. The company plans to submit sBLA in recurrent pericarditis to the US FDA in late 2020
• Earlier- the company has reported the results of P-III RHAPSODY study that met its all 1EPs & 2EPs showing that the therapy improved clinical outcomes associated with the unmet medical need in recurrent pericarditis
• Rilonacept (SC- qw) is a recombinant fusion protein that blocks IL-1α and IL-1β signaling and has received the US FDA’s BT designation in 2019. In 2017- Regeneron out-licensed rilonacept to Kiniksa for recurrent pericarditis under which Regeneron will receive equal profit on sales of the therapy- if approved in the US

  Ref: Kiniksa | Image: Kiniksa