Zilebesiran awarded 'Innovation Passport' by UK regulator for hypertension

US RNAi therapeutics company Alnylam Pharmaceuticals (Nasdaq: ALNY) today announced that zilebesiran (formerly ALN-AGT), an investigational RNAi therapeutic targeting liver-expressed angiotensinogen (AGT), has been awarded an Innovation Passport for the treatment of hypertension by the UK Medicines and Healthcare products Regulatory Agency (MHRA), National Institute for Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC) and the All Wales Therapeutics and Toxicology Centre (AWTTC).

The Innovation Passport is the entry point to the UK’s Innovative Licensing and Access Pathway (ILAP), which aims to accelerate the time it takes to bring a molecule to market and facilitate patient access to medicine through the development of a target development profile that outlines a unique product-specific roadmap for regulatory and development milestones [i]. Other benefits of ILAP include a 150-day accelerated assessment of the initial Marketing Authorization Application, rolling review and a continuous benefit-risk assessment.

Zilebesiran is an investigational RNA interference (RNAi) therapeutic targeting angiotensinogen (AGT) – a protein produced by the liver and involved in regulating blood pressure. Zilebesiran is administered under the skin and is designed to inhibit the production of AGT preventing constriction of blood vessels which may help reduce elevated blood pressure.