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AstraZeneca: CHMP Recommends Saphnelo For Approval

By RTTNews Staff Writer   ✉  | Published:  | Google News Follow Us  | Join Us

AstraZeneca (AZN) said its Saphnelo or anifrolumab has been recommended for approval in the European Union as a self-administered once-weekly pre-filled pen for adult patients with systemic lupus erythematosus on top of standard therapy. The CHMP based its positive opinion on interim results from the Phase III TULIP-SC trial.

AstraZeneca acquired global rights to?Saphnelo?through an exclusive license and collaboration agreement with Medarex in 2004. Medarex was acquired by Bristol-Myers Squibb in 2009. AstraZeneca will pay BMS a low to mid-teens royalty for sales dependent on geography.

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