New EU Approvals

The Pink Sheet’s list of EU centralized approvals of new active substances now includes five new products, one of which is BioMarin Pharmaceutical's Palynziq for treating phenylketonuria. The list, which contains information dating back to January 2018, includes brand name, generic name, company, therapeutic indication, date of marketing authorization and product type (eg, medicine, vaccine, biologic).

BioMarin Pharmaceutical’s Palynziq (pegvaliase injection) for treating phenylketonuria in patients aged 16 years or older is among five new additions to the Pink Sheet’s regularly updated list of products containing new active substances that have been approved for marketing in the EU under the centralized authorization procedure. The other new additions are Akcea Therapeutics’ Waylivra (volanesorsen), Portola Pharmaceuticals’ Ondexxya (andexanet alfa), AbbVie’s Skyrizi (risankizumab) and Sanofi/Lexicon Pharmaceuticals’ Zynquista (sotagliflozin).

The great majority of new, innovative medicines and vaccines that are marketed in the EU go through the centralized procedure....