After Novartis’ Adakveo was pulled in Europe, the UK follows suit
Novartis is pulling Adakveo from the UK market as its clinical benefits no longer outweigh its risks, a month after the Medicines and Healthcare products Regulatory Agency (MHRA) revoked the marketing authorization of the drug.
The MHRA revoked the marketing authorization of Adakveo on Jan. 10. The European Commission also pulled the drug last August, following an EMA recommendation in May.
The revoked authorizations follow the completion of Novartis’ Phase III STAND trial, which failed to show Adakveo performed better than placebo. The drug is still approved in the US market and Novartis “continues to discuss the STAND study results with FDA,” according to the company’s annual report on Jan 31.
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