Boehringer’s Spesolimab Wins First Approval In Rare Skin Condition
May Commercialize Therapy Alone
The German firm’s monoclonal antibody has received a US thumbs-up for a severe skin disease with high unmet need but it must address diagnostic and educational hurdles.
You may also be interested in...
Keeping Track: US FDA Novel Approvals Return With Xenpozyme, Spevigo Nods; Stimufend Survives COVID-19 Delays
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
The company is discontinuing the drug’s development in hidradenitis suppurativa after a Phase II flop, leaving GPP as the only viable indication, for which it is planning to out-license the drug.
With 19 novel approvals and 14 complete response letters in the first half of 2022, the year is shaping up to be a turnabout from the big approval counts and rare CRLs of the recent approvals boom years.