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Keeping Track: US FDA Approves J&J’s Novel MS Drug Ponvory, Breakthrough Pericarditis Claim For Kiniksa’s Arcalyst

 
• By Bridget Silverman

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

Keeping Track Feature image

A new molecular entity approval for Johnson & Johnson’s Ponvory capped the past week at the US FDA, but a new indication for Arcalyst – now marketed byKiniksa Pharmaceuticals Corporation – made the biologic one of the few approved cardiovascular agents to hold a breakthrough therapy designation.

Another cardiovascular candidate with a BTD, mavacamten, was submitted for approval by Bristol Myers Squibb Company, just months after the

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