[Opinion] EMA Advisors Say CSL's Tavneos Should Be Pulled From Sale
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4 Articles
Amsterdam – The C5a antagonist Avacopan (trade name Tavneos), used to treat ANCA-associated vasculitis in adults, had already come under criticism due to the risk of liver damage. Drug authorities are now also accusing the manufacturer at the time, ChemoCentryx, of data manipulation in the pivotal Phase 3 ADVOCATE trial...
EMA recommends three new medicines and an orphan treatment for rare Rett Syndrome
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 aga…
The European Medicines Agency (EMA) recommended on the 29th that the manufacturing and marketing authorization for Tabneos (generic name avacopan), a vasculitis treatment developed by a US company, be revoked in the European Union (EU) due to doubts about its effectiveness. The European Commission will decide whether to accept the recommendation. EMA
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