MHRA Awards Alnylam Innovation Passport for Hypertension Candidate

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) granted Alnylam Pharmaceuticals’ investigational RNA interference (RNAi)-based therapy zilebesiran an Innovation Passport for treatment of hypertension.

The new MHRA designation gives applicants access to the agency’s Innovative Licensing and Access Pathway (ILPA) that aims to accelerate the review process as well as offer timelier patient access to drugs.

Alnylam is currently evaluating zilebesiran in a phase 2 study as an add-on therapy for patients with hypertension not adequately controlled by a standard of care antihypertensive drug.

The company believes its subcutaneous formulation may be more effective in controlling hypertension, noting that “despite the availability of oral antihypertensive therapies, many patients remain uncontrolled.”