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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.

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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.

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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.

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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 July 2023, and is available in the DIDB Resource Center.

In this update, 25 compounds were identified as substates, inhibitors, and inducers of CYP enzymes and transporters (P-gp, BCRP, and OATP1B1/3). Among them, 3 compounds were sensitive substrates and could lead to strong drug interactions mediated by CYP1A2, 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.

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Data Curation and Entry in DIDB – June Summary

In June, we added 77 citations in DIDB, including 22 in vitro (with 15 articles published in June 2023) and 55 in vivo articles (with 45 articles published in June 2023).

3 recently approved NDAs/BLAs were also added: leniolisib (JOENJA), pegunigalsidase alfa (ELFABRIO), fezolinetant (VEOZAH).

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.

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We are now Certara

“We are thrilled to share an important development related to Drug Interaction Solutions (DIS) and the DIDB® – The Drug Interaction Database, which you and your teams have relied on over the years. As of June 21, 2023, DIS and DIDB® have been acquired by Certara – a global leader in biosimulation and technology-enabled services that accelerate drug development. 

This move represents a significant milestone in the growth and development of DIDB® and further strengthens its position as an internationally recognized authoritative, unbiased, and transparent drug development tool. As a part of Certara’s data sciences portfolio, we know we have found the right home for DIDB® to continue towards becoming a standard in supporting drug development, healthcare applications, and complex clinical decision algorithms.”

UW CoMotion

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Data Curation and Entry in DIDB – May Summary

In May, we added 107 citations in DIDB, including 45 in vitro (with 14 articles published in May 2023) and 62 in vivo articles (with 39 articles published in May 2023).

2 recently approved NDAs/BLAs were also added: retifanlimab (DAYBUE), tofersen (QALSODY).

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.

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DIDB Team to participate in the 2023 Marbach DDI Workshop, June 4-6, in Germany

Drs. Isabelle Ragueneau-Majlessi and Jingjing Yu will give two talks at the upcoming 2023 Marbach DDI workshop, June 4-6, Marbach Castle, Germany.

Dr Isabelle Ragueneau-Majlessi will speak about the “Important Methodological Aspects of Smoking Interactions Studies – Review of three Decades of Literature”.

Dr Jingjing Yu will present an”Overview of 2022 NDA Reviews: Understanding the Risk of Metabolism- and Transporter-Based Drug-Drug Interactions with Novel Drugs Approved by the US FDA”.

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Data Curation and Entry in DIDB – April Summary

In April, we added 111 citations in DIDB, including 40 in vitro (with 11 articles published in April 2023) and 71 in vivo articles (with 43 articles published in April 2023).

Four recently approved NDAs were also added: elacestrant (ORSERDU), omaveloxolone (SKYCLARYS), trofinetide (DAYBUE), zavegepant (ZAVZPRET).

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.