Putting its pivotal failure in the rearview mirror, AstraZeneca scores an EU nod for its lupus drug
After a bumpy road to approval in the US, AstraZeneca is touting a nod for Saphnelo in the EU to treat moderate to severe systemic lupus erythematosus (SLE), an autoimmune disease in which the immune system attacks healthy tissue in the body.
The news doesn’t come as much of a surprise, as the EMA’s Committee for Medicinal Products for Human Use (CHMP) offered up a positive recommendation for the drug back in December. Investors were mostly muted on Wednesday morning, with $AZN stock up less than 1%.
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