Regeneron

This sponsor has funded 10 studies across 39 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
17314 Finalised EU RMP category 3 Monitoring the safety of alirocumab in HIV patients: A Post-Authorization Safety Study Using Healthcare Databases Yes Yes
21314 Finalised EU RMP category 3 A drug utilization study (DUS) of alirocumab in Europe to assess the effectiveness of the dosing recommendation to avoid very low LDL-C levels Yes Yes
25203 Ongoing Not included in RMP Asthma and Type 2 Comorbidities - Real-life Characterisation of Patients with Active Asthma and Type 2 Asthma Comorbidities Yes No
37360 Finalised Not included in RMP International Registry of Coronavirus Exposure in Pregnancy (IRCEP) Yes No
41565 Ongoing Not included in RMP Assessing Long-Term Outcomes of DUPIXENT® Treatment in Patients with Chronic Rhinosinusitis with Nasal Polyposis (AROMA) No No
41963 Ongoing Not included in RMP Registry of Asthma Patients Initiating DUPIXENT® (RAPID) No No
42461 Finalised Not included in RMP A Retrospective Evaluation of Conjunctivitis and Keratitis Among Individuals with Moderate-to-severe Atopic Dermatitis Treated with Dupilumab in the... No Yes
43819 Ongoing EU RMP category 3 Post-Authorization Safety Study to Monitor Pregnancy and Infant Outcomes Following Administration of Dupilumab During Planned or Unexpected Pregnancy... No No
43837 Ongoing EU RMP category 3 Dupilumab and Pregnancy Outcomes: A Retrospective Cohort Study Using Administrative Healthcare Databases (Dupi PODS) No No
49201 Ongoing Not included in RMP Characteristics of type 2 asthma phenotypes and oral corticosteroid (OCS) use in the International Severe Asthma Registry (ISAR) (STAR) No No

PAS by Risk Management Plan (RMP) requirement

Regeneron

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.