EMA Calls for Novartis’ Sickle Cell Treatment to Lose Market Authorization

Novartis took a hit this week as the European Medicines Agency (EMA) has recommended that its market authorization for Adakveo, a sickle cell medication, be revoked. Although initial data suggested the drug could help reduce pain crises in patients 16 and older, the agency argues that new data showing increased levels of serious side effects do not outweigh the modest treatment effect.

According to Emily Kimber, “The study also showed that Adakveo did not reduce the number of painful crises leading to a healthcare visit, with patients in the Adakveo group experiencing an average of 2.5 over the first year of treatment, compared with 2.3 in the placebo cohort. Additionally, the average number of crises requiring a healthcare visit or treatment at home was 4.7 with Adakveo compared with 3.9 for those receiving placebo.”

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(Source: PM Live, May 30^th, 2023)