Akcea Therapeutics

This sponsor has funded 4 studies across 12 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
36702 Planned EU RMP category 2 WAYLIVRA® Post-Authorisation Safety Study (PASS) and Product Registry (WAYLIVRA PASS) No No
37728 Planned EU RMP category 3 A Prospective, Non-interventional, Long-term, Multinational Cohort Safety Study of Patients with Hereditary Transthyretin Amyloidosis with... No No
37731 Planned EU RMP category 3 A Retrospective, Non-interventional, Multi-centre Study of TEGSEDI-treated Patients to Evaluate Real-world Adherence to, and Effectiveness of the... No No
41839 Planned EU RMP category 3 Pregnancy Surveillance Program of Women and Infants Exposed to TEGSEDI During Pregnancy (TEDSEDI-PRG) No No

PAS by Risk Management Plan (RMP) requirement

Akcea Therapeutics

The RMP for a medical product outlines strategies to identify, assess, and mitigate risks, including PAS for further evaluation.

Category 1 studies are imposed as condition of marketing authorisation.
Category 2 studies are imposed as specific obligation of marketing authorisation.
Category 3 studies are required under other circumstances.