News

 |  New features

PMRs/PMCs for drugs approved by the FDA in 2014, 2015, and 2016 – Additional information now available in DIDB

As the DIDB content continues to expand, we are pleased to announce that post-marketing requirements and post-marketing commitments (PMRs and PMCs) for drugs approved by the FDA in 2014, 2015, and 2016 have now been entered in the DIDB. The DDI, hepatic impairment, and renal impairment results can be found under the drug’s original NDA or BLA numbers. Updated label recommendations are also presented in the drug DDI Summary.

Having access to this additional information is key to fully understand the DDI profile of NMEs, and the DIDB Editorial Team is now working on PMR/PMC data for drugs approved in 2017 and 2018.

As always, feel free to contact us at DIDBase@certara.com if you have any questions or comments.

 |  News

Data Curation and Entry in DIDB – October Summary

In October, we added 110 citations in DIDB, including 47 in vitro (with 16 articles published in October 2023) and 63 in vivo articles (with 38 articles published in October 2023).

4 recently approved NDAs/BLAs were also added: elranatamab (ELREXFIO), momelotinib (OJJAARA), pozelimab (VEOPOZ), sotagliflozin (INPEFA).

You can check the citations that are recently published and entered in DIDB and all the NDAs/BLAs in DIDB.

As always, feel free to contact us if you have any questions or comments.

 |  New features

Video tutorials for DIDB users – Updated

Did you know that we have recently recorded / updated 19 training videos to help DIDB users to make full use of the database?

Those videos are available in the DIDB Resource Center as well as on the DIDB pages that are relevant to their content. For example, on the Drug Query page you have access to 3 related videos, on the QT Interval page to 1 related video …

Please note that you must be signed-in to access.

Feel free to suggest additional topics for training videos that you will find useful. Please contact us. Thank you.

 |  News

DDI Marker Studies Knowledgebase – quarterly update

The DDI Marker Studies Knowledgebase (replacing the previous combined and individual lists of CYP/P-gp substrates and perpetrators) has been updated in October 2023, and is available in the DIDB Resource Center.

In this update, 35 compounds were identified as substates, inhibitors, and inducers of CYP enzymes and transporters (P-gp, BCRP, and OATP1B1/3). Among them, 2 compounds were sensitive substrates and 3 compounds were strong inhibitors which could lead to strong drug interactions mediated by CYP2D6 and CYP3A.

In addition to substrates, inhibitors and inducers of CYPs and transporters, the Knowledgebase provides useful information on the compounds therapeutic class, clinical recommended dosage, pharmacokinetics (e.g., dose proportionality accumulation ratio, time to steady-state), QT prolongation, and NTI characteristics.

As always, feel free to contact us if you have any questions or comments.

 |  News

Data Curation and Entry in DIDB – September Summary

In September, we added 74 citations in DIDB, including 33 in vitro (with 12 articles published in September 2023) and 41 in vivo articles (with 22 articles published in September 2023).

6 recently approved NDAs/BLAs were also added: avacincaptad pegol (IZERVAY), lotilaner (XDEMVY), nirmatrelvir and ritonavir (PAXLOVID),palovarotene (SOHONOS),  somatrogon (NGENLA), talquetamab (TALVEY).

You can check the citations that are recently published and entered in DIDB and all the NDAs/BLAs in DIDB.

As always, feel free to contact us if you have any questions or comments.

 |  News

Data Curation and Entry in DIDB – August Summary

In August, we added 117 citations in DIDB, including 63 in vitro (with 23 articles published in August 2023) and 54 in vivo articles (with 30 articles published in August 2023).

3 recently approved NDAs/BLAs were also added: glofitamab (COLUMVI), nirsevimab (BEYFORTUS), quizartinib (VANFLYTA)

You can check the citations that are recently published and entered in DIDB and all the NDAs/BLAs in DIDB.

As always, feel free to contact us if you have any questions or comments.

 |  Posters
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Understanding the role of CYP3A in the metabolism of kinase inhibitors marketed in the past decade to better manage the risk of clinical drug-drug interactions.

Presented at the 25th North American ISSX Meeting, September 2023
Jingjing Yu, Sophie Argon, Katie Owens, Ichiko Petrie, and Isabelle Ragueneau-Majlessi

2023 ISSX Poster Presentation – CYP3A-Kinase inhibitors

Abstract

Kinase inhibitors (KIs) are among the most represented therapeutic areas for novel drugs approved in recent years. In the present analysis, drug metabolism data for all KIs approved in the US since 2011 were reviewed. Mechanistic clinical drug interaction studies with CYP3A perpetrators were fully analyzed using Certara’s Drug Interaction Database (DIDB®). The mechanism(s) and clinical relevance of these interactions were characterized based on information available in the new drug application reviews.

 |  Posters
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Risk of pharmacokinetic drug-drug interactions with novel drugs approved by the US FDA in 2022: a detailed review of DDI data from NDA documentation.

Presented at the 25th North American ISSX Meeting, September 2023
Jingjing Yu, Yan Wang, and Isabelle Ragueneau-Majlessi

2023 ISSX Poster Presentation – 2022 NDA Reviews

Abstract

Understanding the ADME processes involved in pharmacokinetic-based drug-drug interactions (DDIs) is critical to facilitate an optimal management of DDIs in the clinic. In the present work, drug metabolism and transport in vitro and in vivo data for small molecular drugs approved by the U.S. Food and Drug Administration in 2022 (N=22) were analyzed using the Certara Drug Interaction Database. The mechanism(s) and clinical relevance of these interactions were characterized based on information available in the new drug application (NDA) reviews.

 |  Events

Certara Drug Interaction Solutions team members to attend the 25th North American ISSX Meeting in Boston

Drs Isabelle Ragueneau-Majlessi, and Jingjing Yu, respectively Senior Director and Associate Director at Certara Drug Interaction Solutions will be attending the ISSX Meeting in Boston, MA on Sept 10-13, 2023. In addition to Certara booth, we hope to meet you at our two posters:

  • “Risk of pharmacokinetic drug-drug interactions with novel drugs approved by the US FDA in 2022: a detailed review of DDI data from NDA documentation.” #P69 to be presented by Jingjing Yu on Sept 12 between 12:30-1:30pm
  • “Understanding the role of CYP3A in the metabolism of kinase inhibitors marketed in the past decade to better manage the risk of clinical drug-drug interactions.” #P68 to be presented by Jingjing Yu on Sept 12 between 1:30-2:30pm

If you wish to set up a meeting with Isabelle and/or Jingjing at the conference, please contact us at DIDBase@certara.com. We look forward to catching up with you there.

 |  News

Data Curation and Entry in DIDB – July Summary

In July, we added 110 citations in DIDB, including 55 in vitro (with 21 articles published in July 2023) and 55 in vivo articles (with 33 articles published in July 2023).

4 recently approved NDAs/BLAs were also added: flotufolastat F-18 gallium (POSLUMA), ritlecitinib (LITFULO), rozanolixizumab (RYSTIGGO), sulbactam and durlobactam (XACDURO)

You can check the citations that are recently published and entered in DIDB and all the NDAs/BLAs in DIDB.

As always, feel free to contact us if you have any questions or comments.