PCR43 A Review of Migraine-Related Pros in FDA Labelling Claims (2018-2023)
Само за регистроване кориснике
2023
Конференцијски прилог (Објављена верзија)
,
Elsevier
Метаподаци
Приказ свих података о документуАпстракт
Objective
The objective of this review was to characterize the inclusion of migraine patient-reported outcomes (PROs) in FDA approvals subsequent the FDA’s release in 2018 of the Patient Focused Drug Development (PFDD) guidance.
Methods
The PROLABELS database was searched over a 5-year period between June 2018 and June 2023 for migraine disorders with label claims referencing migraine-specific PROs. The PROLABELS database is a commercially available database for Clinical Outcome Assessment (COA) endpoint strategies that are used to demonstrate the efficacy and safety of drugs or devices in the market approval process.
Results
Eleven drugs with migraine PROs in the label were identified. The primary and secondary endpoints were most often assessed using daily diaries measuring the number of monthly migraine days (n=5, 45%) or headache pain occurring two hours post dosing (n=5, 45%), use of rescue medication (n=3, 27%), most bothersome symptom freedom at two hours post-dosage (n...=5, 45%), pain relief 2hrs post dose (n=5, 45%), migraine associated symptoms (n=4, 36%), headache severity diary (n=1, 1%), and activities of daily living and motor function due to migraine (n=1, 1%). Other validated PRO questionnaires included the labels assessed the impact of migraine (n=2, 18%), and migraine quality of life (n =1, 1%).
Conclusions
Only 11 migraine-related therapies were approved by FDA in the 5-year period since the FDA released its PFDD guidance that incorporated migraine-specific PROs in the product label. Data used to assess endpoints were most often gathered using daily dairies. However, only two migraine-related diaries included in label claims have been published to date. Future work should focus on further development of diaries for migraine symptoms meeting the labelling claims criteria. The availability of such diaries to the scientific community could facilitate timely access to effective migraine treatments.
Кључне речи:
migraine / fda / symptoms / drug therapy / pcr43Извор:
Value in Health, 2023, 26, 12, S456-S457Издавач:
- Elsevier
Институција/група
Psihologija / PsychologyTY - CONF AU - Zupan, Zorana AU - Doma, Rinchen AU - Heinrich, Maggie AU - Rudell, Katja PY - 2023 UR - http://reff.f.bg.ac.rs/handle/123456789/6014 AB - Objective The objective of this review was to characterize the inclusion of migraine patient-reported outcomes (PROs) in FDA approvals subsequent the FDA’s release in 2018 of the Patient Focused Drug Development (PFDD) guidance. Methods The PROLABELS database was searched over a 5-year period between June 2018 and June 2023 for migraine disorders with label claims referencing migraine-specific PROs. The PROLABELS database is a commercially available database for Clinical Outcome Assessment (COA) endpoint strategies that are used to demonstrate the efficacy and safety of drugs or devices in the market approval process. Results Eleven drugs with migraine PROs in the label were identified. The primary and secondary endpoints were most often assessed using daily diaries measuring the number of monthly migraine days (n=5, 45%) or headache pain occurring two hours post dosing (n=5, 45%), use of rescue medication (n=3, 27%), most bothersome symptom freedom at two hours post-dosage (n=5, 45%), pain relief 2hrs post dose (n=5, 45%), migraine associated symptoms (n=4, 36%), headache severity diary (n=1, 1%), and activities of daily living and motor function due to migraine (n=1, 1%). Other validated PRO questionnaires included the labels assessed the impact of migraine (n=2, 18%), and migraine quality of life (n =1, 1%). Conclusions Only 11 migraine-related therapies were approved by FDA in the 5-year period since the FDA released its PFDD guidance that incorporated migraine-specific PROs in the product label. Data used to assess endpoints were most often gathered using daily dairies. However, only two migraine-related diaries included in label claims have been published to date. Future work should focus on further development of diaries for migraine symptoms meeting the labelling claims criteria. The availability of such diaries to the scientific community could facilitate timely access to effective migraine treatments. PB - Elsevier C3 - Value in Health T1 - PCR43 A Review of Migraine-Related Pros in FDA Labelling Claims (2018-2023) EP - S457 IS - 12 SP - S456 VL - 26 DO - https://doi.org/10.1016/j.jval.2023.09.2482 ER -
@conference{ author = "Zupan, Zorana and Doma, Rinchen and Heinrich, Maggie and Rudell, Katja", year = "2023", abstract = "Objective The objective of this review was to characterize the inclusion of migraine patient-reported outcomes (PROs) in FDA approvals subsequent the FDA’s release in 2018 of the Patient Focused Drug Development (PFDD) guidance. Methods The PROLABELS database was searched over a 5-year period between June 2018 and June 2023 for migraine disorders with label claims referencing migraine-specific PROs. The PROLABELS database is a commercially available database for Clinical Outcome Assessment (COA) endpoint strategies that are used to demonstrate the efficacy and safety of drugs or devices in the market approval process. Results Eleven drugs with migraine PROs in the label were identified. The primary and secondary endpoints were most often assessed using daily diaries measuring the number of monthly migraine days (n=5, 45%) or headache pain occurring two hours post dosing (n=5, 45%), use of rescue medication (n=3, 27%), most bothersome symptom freedom at two hours post-dosage (n=5, 45%), pain relief 2hrs post dose (n=5, 45%), migraine associated symptoms (n=4, 36%), headache severity diary (n=1, 1%), and activities of daily living and motor function due to migraine (n=1, 1%). Other validated PRO questionnaires included the labels assessed the impact of migraine (n=2, 18%), and migraine quality of life (n =1, 1%). Conclusions Only 11 migraine-related therapies were approved by FDA in the 5-year period since the FDA released its PFDD guidance that incorporated migraine-specific PROs in the product label. Data used to assess endpoints were most often gathered using daily dairies. However, only two migraine-related diaries included in label claims have been published to date. Future work should focus on further development of diaries for migraine symptoms meeting the labelling claims criteria. The availability of such diaries to the scientific community could facilitate timely access to effective migraine treatments.", publisher = "Elsevier", journal = "Value in Health", title = "PCR43 A Review of Migraine-Related Pros in FDA Labelling Claims (2018-2023)", pages = "S457-S456", number = "12", volume = "26", doi = "https://doi.org/10.1016/j.jval.2023.09.2482" }
Zupan, Z., Doma, R., Heinrich, M.,& Rudell, K.. (2023). PCR43 A Review of Migraine-Related Pros in FDA Labelling Claims (2018-2023). in Value in Health Elsevier., 26(12), S456-S457. https://doi.org/https://doi.org/10.1016/j.jval.2023.09.2482
Zupan Z, Doma R, Heinrich M, Rudell K. PCR43 A Review of Migraine-Related Pros in FDA Labelling Claims (2018-2023). in Value in Health. 2023;26(12):S456-S457. doi:https://doi.org/10.1016/j.jval.2023.09.2482 .
Zupan, Zorana, Doma, Rinchen, Heinrich, Maggie, Rudell, Katja, "PCR43 A Review of Migraine-Related Pros in FDA Labelling Claims (2018-2023)" in Value in Health, 26, no. 12 (2023):S456-S457, https://doi.org/https://doi.org/10.1016/j.jval.2023.09.2482 . .