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EMA recommends three new medicines and an orphan treatment for rare Rett Syndrome

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At its monthly meeting, the human medicines committee approved six medicines, issued three negative opinions and gave positive opinions on the extensions of thirteen therapeutic indications.

CSL Seqirus had a mostly good week. In addition to the Commission starting its investigation into possible disparagement (see below), EMA has recommended granting a marketing authorisation for Aujemflu, a vaccine to protect people aged 50 years and older against influenza.

However, the CHMP recommended that Tavneos (avacopan), a medicine used to treat two inflammatory conditions in blood vessels, have its market authorisation revoked. The Committee found that data provided from its main ‘Advocate’ study had been incorrect and misleading. As the study was found to breach good clinical practice (GCP), it was concluded that it could not be relied on for the earlier positive decision.

CSL Seqirus published a letter from their Senior Vice President for Medical Affairs, Dr Deborah Long addressed to “the ANCA /(Anti-neutrophil cytoplasmic antibody) Associated Vasculitis Community”, acknowledging that the news may be difficult and “naturally raises questions about ongoing treatment”...

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