Product information and disease description Place of product in therapy Approaches to treatment

Ongoing post-approval monitoring

6 evidence topics · 6 sources

Extension phase of the pivotal A-T trial

“Patients who have participated in the study may be offered the opportunity to roll over into an Extension Phase, which is planned to allow patients to have further access to IB1001.” (opens the source at this quote in a new tab)
“Randomized, placebo-controlled, double-blind, crossover, multi-center, study with 1:1 randomization of IB1001 plus SOC for 12-weeks versus placebo plus SOC for 12-weeks, followed by open-label extension study.” (opens the source at this quote in a new tab)

“The study includes a randomized, placebo-controlled, double-blind crossover phase, followed by a long-term open-label extension.” (opens the source at this quote in a new tab)
“It was designed in partnership with key opinion leaders and A-T patient organizations to evaluate both symptomatic effects and longer-term clinical outcomes.” (opens the source at this quote in a new tab)

Adverse reaction reporting

“To report SUSPECTED ADVERSE REACTIONS, contact IntraBio Inc. at 1-833-306-9677 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.” (opens the prescribing information at this quote)

Monitoring recommended in the prescribing information

“Monitor more frequently for P-gp substrate related adverse reactions when used concomitantly with AQNEURSA.” (opens the prescribing information at this quote)
“For females of reproductive potential, verify that the patient is not pregnant prior to initiating treatment with AQNEURSA.” (opens the prescribing information at this quote)

Periodic status reports on postmarketing studies

“Section 505(o)(3)(E)(ii) of the FDCA requires you to report periodically on the status of any study or clinical trial required under this section.” (opens the source at this quote in a new tab)
“This section also requires you to periodically report to FDA on the status of any study or clinical trial otherwise undertaken to investigate a safety issue.” (opens the source at this quote in a new tab)

European Union pharmacovigilance: additional monitoring

“This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines.” (opens the source at this quote in a new tab)
“As for all medicines, data on the use of Aqneursa are continuously monitored.” (opens the source at this quote in a new tab)

Real-world evidence collection through the specialty pharmacy

“In collaboration with IntraBio, Curant Rare developed a first-of-its-kind real-world evidence (RWE) system that is delivering unprecedented NPC insights to the scientific community.” (opens the source at this quote in a new tab)

Product registry for ataxia-telangiectasia

No evidence found.