CYP3A

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5-8 February 2024

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Saturday, February 10, 2024
Communication, Signal, PRAC, Civil service commission, COVID-19, Protein, European Commission, Everolimus, RMP, Vaccine, Health care, EMA, Risk, CHMP, Ritonavir, Immune system, Marketing, CYP3A, Data, Plasma protein binding, Tacrolimus, State, Medicine, Sirolimus, Disease

EMA’s safety committee (PRAC) is reminding healthcare professionals of the risk of serious and potentially fatal adverse reactions with Paxlovid (nirmatrelvir, ritonavir) when…, Agenda Agenda of the PRAC meeting 5-8 February 2024DraftFirst published: 05/02/2024Last updated: 06/02/2024Reference Number: EMA/PRAC/11237/2024…, PRAC statistics: February 2024, PRAC statistics: February 2024First published: 09/02/2024 English (EN) (22.52 MB - PDF)View , Glossary:Safety signal assessments.

Key Points: 
  • EMA’s safety committee (PRAC) is reminding healthcare professionals of the risk of serious and potentially fatal adverse reactions with Paxlovid (nirmatrelvir, ritonavir) when…, Agenda Agenda of the PRAC meeting 5-8 February 2024DraftFirst published: 05/02/2024Last updated: 06/02/2024Reference Number: EMA/PRAC/11237/2024…, PRAC statistics: February 2024, PRAC statistics: February 2024First published: 09/02/2024 English (EN) (22.52 MB - PDF)View , Glossary:Safety signal assessments.
  • A safety signal is information which suggests a new potentially causal association, or a new aspect of a known association between a medicine…, Ongoing referralsProcedureStatusUpdateHydroxyprogesterone-containing medicinal products – Article-31 referralUnder evaluationPRAC continued its assessment

Human medicines European public assessment report (EPAR): Symkevi, tezacaftor,ivacaftor, Date of authorisation: 31/10/2018, Revision: 13, Status: Authorised

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Tuesday, January 2, 2024
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Human medicines European public assessment report (EPAR): Symkevi, tezacaftor,ivacaftor, Date of authorisation: 31/10/2018, Revision: 13, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Symkevi, tezacaftor,ivacaftor, Date of authorisation: 31/10/2018, Revision: 13, Status: Authorised

Investigators from John Byrd's Lab at University of Cincinnati Presented Non-Clinical Summary Data for The Best-in-Class Selective BCL2 Inhibitor Clinical Candidate Developed by Eilean Therapeutics in Collaboration with ChemDiv

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Wednesday, December 13, 2023
BCL2, SAN, Expert system, Chemical Diversity, CYP3A, Eilean Donan, Pharmacology, University, Cancer, Safety, University of Cincinnati, Venetoclax, Pharmaceutical industry

"A Novel Selective BCL2 Inhibitor with Limited Immune Suppression and Improved Safety Compared to Venetoclax" was presented by collaborators from University of Cincinnati (Ohio), Molsoft LLC, Expert Systems Inc of San Diego California, and Eilean Therapeutics LLC of Dover, Delaware.

Key Points: 
  • "A Novel Selective BCL2 Inhibitor with Limited Immune Suppression and Improved Safety Compared to Venetoclax" was presented by collaborators from University of Cincinnati (Ohio), Molsoft LLC, Expert Systems Inc of San Diego California, and Eilean Therapeutics LLC of Dover, Delaware.
  • The presentation highlighted best-in-class potency and selectivity against BCL2, a key pro-survival protein that is overexpressed in many cancers.
  • This clinical candidate demonstrated an equivalent in vivo anti-tumor efficacy as venetoclax in both B cell and myeloid malignancy cell lines and in vivo models.
  • Compared to venetoclax, the candidate exhibits significantly less suppression of non-malignant immune cell populations, a result that signals superior selectivity and improved safety profile.

Pfizer Presents New Data at IDWeek 2023 Highlighting Advances in Prevention and Treatment of Certain Respiratory Illnesses and Other Infectious Diseases

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Thursday, October 5, 2023
Biotechnology, Pharmaceutical, Oncology, General Health, Health, FDA, COVID-19, Clinical Trials, Pain, Shenzhen Kangtai Biological Products, Food, Gram-negative bacteria, Preterm birth, Act, Death, Ritonavir, Plasma, Treatment, Myalgia, Stevens–Johnson syndrome, EUA, Risk, Hospital, Jaundice, Emergency Use Authorization, Nausea, Allergy, Microsome, Headache, Fatigue, CYP3A, Immune system, Safety, History, Regulation of tobacco by the U.S. Food and Drug Administration, Gestational age, Post-exposure prophylaxis, Anaphylaxis, Patient, Medicine, Vaccine, Pharmaceutical industry, Birth control

PAXLOVID is not approved for use as pre-exposure or post-exposure prophylaxis for prevention of COVID-19.

Key Points: 
  • PAXLOVID is not approved for use as pre-exposure or post-exposure prophylaxis for prevention of COVID-19.
  • There are certain other drugs for which concomitant use with PAXLOVID should be avoided and/or dose adjustment, interruption, or therapeutic monitoring is recommended.
  • Drugs listed here are a guide and not considered a comprehensive list of all drugs that may be contraindicated with PAXLOVID.
  • Drugs that are primarily metabolized by CYP3A for which elevated concentrations are associated with serious and/or life-threatening reactions:
    Microsomal triglyceride transfer protein inhibitor: lomitapide

Exavir Therapeutics Receives $3M Award from NIH / NIAID to Advance Ultra-Long-Acting Integrase Inhibitor XVIR-110

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Tuesday, August 22, 2023
White House, Federal Government, AIDS, Public Policy, Government, Health, Infectious Diseases, Pharmaceutical, Biotechnology, Therapy, HIV, National Institute of Allergy and Infectious Diseases, Pharmacokinetics, CYP3A, CNS, Patient, Central nervous system disease, NIAID, IND, NIH, Infection, Foundation for the National Institutes of Health, Conditional sentence, Pharmaceutical industry

Exavir Therapeutics, a company dedicated to transforming the lives of patients with chronic viral infections and CNS disorders with ultra-long-acting therapeutics, today announced that the company has received a $3M award from the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institute of Health (NIH), to support the development of XVIR-110.

Key Points: 
  • Exavir Therapeutics, a company dedicated to transforming the lives of patients with chronic viral infections and CNS disorders with ultra-long-acting therapeutics, today announced that the company has received a $3M award from the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institute of Health (NIH), to support the development of XVIR-110.
  • XVIR-110 is an ultra-long-acting HIV integrase inhibitor with a preclinical profile that suggests best-in-class potential for HIV pre-exposure prophylaxis (PrEP), and for HIV treatment as the cornerstone of a next-generation multi-drug regimen.
  • “We are thankful for the NIH’s support of American companies and innovative biotechnology, particularly in an area like HIV / AIDS that affects so many millions of people worldwide,” said Alborz Yazdi, co-founder and CEO of Exavir.
  • “This award speaks to XVIR-110’s transformative potential, but also the importance of American agencies and public-private partnerships in improving population health outcomes.

FORE Biotherapeutics to Present Promising New Data from Phase 1/2a Trial Evaluating Plixorafenib (FORE8394) in Patients With BRAF-Altered Advanced Solid and Central Nervous System Tumors at ASCO 2023

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Friday, May 26, 2023
Oncology, Health, FDA, Genetics, Clinical Trials, Pharmaceutical, Biotechnology, University, PRS, PD, Shepherd, CRC, AE, Diarrhea, Neoplasm, Safety, Primary central nervous system lymphoma, DOR, Aes, MAPK, CYP3A, BRAF, Doctor of Philosophy, CNS, Associate, Glioblastoma, ASCO, V600, Malignancy, Neuro, American Society of Clinical Oncology, HIV disease progression rates, MD, Patient, Agency, Colorectal cancer, FORTE, Cancer, Annual general meeting, Memorial Sloan Kettering Cancer Center, Nausea, Orphan, Cobicistat, Ovarian cancer, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Society, Fasting, ORR, Food, Fatigue, Disease, Pharmaceutical industry, Medical imaging, Vaccine, Phosphorus

The results demonstrate promising single-agent activity against BRAF-altered tumors, including primary central nervous system (CNS) tumors, and will be featured in presentations at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, being held June 2-6, 2023, in Chicago, IL.

Key Points: 
  • The results demonstrate promising single-agent activity against BRAF-altered tumors, including primary central nervous system (CNS) tumors, and will be featured in presentations at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, being held June 2-6, 2023, in Chicago, IL.
  • “The updated data from our Phase 1/2a study further reinforces plixorafenib’s differentiated clinical profile,” said Stacie Shepherd, MD, PhD, and Chief Medical Officer of FORE.
  • “Plixorafenib has demonstrated both promising antitumor activity with durable responses and favorable tolerability as a single agent in patients with advanced BRAF-altered tumors.
  • Details for the ASCO 2023 presentations are as follows:
    Title: Safety and efficacy of the novel BRAF inhibitor FORE8394 in patients with advanced solid and CNS tumors: Results from a phase 1/2a study

Reviva Pharmaceuticals Announces Presentation of Clinical Pharmacology Studies Data on Brilaroxazine at the ASPET 2023 Annual Meeting

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Monday, May 22, 2023
Volunteering, Human, Central nervous system, Metabolism, Schizophrenia, American Society for Pharmacology and Experimental Therapeutics, New Drug Application, PME, NDA, CYP3A, Schizoaffective disorder, SAD, Cmax, Experiment, CNS, Clozapine, CYP3A4, Risperidone, Plasma, Aripiprazole, Animal, DSM-IV codes, Patient, Phenytoin, Itraconazole, Mouse, State, Glucuronic acid, Pharmacology, Lurasidone, Society, Brexpiprazole, Cariprazine, Safety, ASPET, Vaccine, Pharmaceutical industry, Brilaroxazine

CUPERTINO, Calif., May 22, 2023 (GLOBE NEWSWIRE) -- Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) (“Reviva” or the “Company”), a clinical-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), respiratory and metabolic diseases, has presented two posters on promising clinical pharmacology and safety studies data on the novel serotonin-dopamine stabilizer brilaroxazine at the American Society for Pharmacology and Experimental Therapeutics (ASPET) 2023 annual meeting took place in St. Louis, Missouri, USA, May 18-21, 2023. The ASPET posters are available at revivapharma.com/publications. Brilaroxazine is currently in phase 3 clinical trials for schizophrenia and topline data from the pivotal phase 3 is anticipated in mid this year.

Key Points: 
  • Brilaroxazine is currently in phase 3 clinical trials for schizophrenia and topline data from the pivotal phase 3 is anticipated in mid this year.
  • “These data support the concomitant use of brilaroxazine with other medications metabolized by CYP3A4 as most schizophrenia patients take multiple concomitant medications.
  • As part of the required clinical studies for New Drug Application (NDA), the drug-drug interactions between brilaroxazine with a strong CYP3A4 inhibitor (itraconazole) and inducer (phenytoin) were evaluated.
  • Brilaroxazine single dose co-administered with phenytoin at steady-state resulted in decrease of ~33%, 57% and 54% in brilaroxazine Cmax, AUC0-t, and AUC0∞, respectively.

Insilico Medicine Announces IND Approval of Oral 3CLpro Inhibitor ISM3312 for COVID-19

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Thursday, February 23, 2023
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ISM3312 is a highly selective 3CLpro inhibitor with a novel molecular structure optimized from compounds designed by Chemistry42, Insilico’s generative chemistry AI platform.

Key Points: 
  • ISM3312 is a highly selective 3CLpro inhibitor with a novel molecular structure optimized from compounds designed by Chemistry42, Insilico’s generative chemistry AI platform.
  • ISM3312 has a novel molecular structure that provides broad anti-coronavirus activity, excellent single agent oral bioavailability, and potential drug-resistant mutations.
  • Insilico Medicine, a clinical-stage biotech company powered by generative AI, today announces that China National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for ISM3312, an orally available 3CLpro inhibitor generated and designed with the support of Insilico’s proprietary generative chemistry platform Chemistry42 for the treatment of COVID-19.
  • “Generative AI is transforming every area of human development,” says Alex Zhavoronkov, PhD, founder and CEO of Insilico Medicine.

Atea Pharmaceuticals Presents Favorable Drug Interaction Profile of Bemnifosbuvir in Phase 1 Studies at CROI 2023

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Thursday, February 23, 2023
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BOSTON, Feb. 23, 2023 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a clinical-stage biopharmaceutical company, today announced that data from three Phase 1 studies suggest a favorable drug-drug interaction profile. No dosage adjustment is needed for CYP3A substrates or for drugs that are sensitive substrates of efflux and hepatic uptake transporters when co-administrated with bemnifosbuvir. CYP3A is an enzyme that metabolizes many classes of prescribed medicines and medicinal supplements, and efflux/hepatic uptake transporters regulate cellular trafficking of many drugs that are commonly prescribed to patients that are at high risk for severe COVID-19.

Key Points: 
  • BOSTON, Feb. 23, 2023 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a clinical-stage biopharmaceutical company, today announced that data from three Phase 1 studies suggest a favorable drug-drug interaction profile.
  • No dosage adjustment is needed for CYP3A substrates or for drugs that are sensitive substrates of efflux and hepatic uptake transporters when co-administrated with bemnifosbuvir.
  • These results were presented at the Conference on Retroviruses and Opportunistic Infections (CROI), which took place February 19-22, 2023 in Seattle, Washington.
  • A single dose (simultaneous or staggered) of bemnifosbuvir 1100 mg administered with ROSU slightly increased the plasma exposure of ROSU.

Optime Care, Specialty Pharmacy Patient Management Organization Announces Enhanced Partnership with Rigel Pharmaceuticals, Inc. for Rezlidhia™ Patients

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Tuesday, December 13, 2022
Biotechnology, FDA, Health, Family, Consumer, Other Health, Pharmaceutical, Oncology, Other Science, Research, Managed Care, Genetics, Science, Women, Recurrence, Liver, Hepatotoxicity, Cancer, Uric acid, Mucositis, Disease, Woman, AML, URAC, Hypertension, Potassium, Transaminase, Rash, Sodium, Azacitidine, Partnership, Degenerative disease, Knowledge, HUB, ACHC, Fatigue, Hypotension, Alkaline phosphatase, Clinical trial, Constipation, Fatality, Leukocytosis, Probability, Retinoic acid syndrome, Creatinine, AST, Diarrhea, Jaundice, Postcholecystectomy syndrome, Weight gain, Market access, Dexamethasone, Purging disorder, Edema, Case management (US healthcare system), Mutation, Acute kidney injury, Lymphocyte, Lipase, Disorder, IDH1, CYP3A, Patient, Myelocyte, Nausea, FDA, Hydroxycarbamide, ALT, Breathe Me, Arthralgia, Bilirubin, Accreditation Commission for Health Care, Acute myeloid leukemia, Pharmaceutical industry, Generic drug, Rigel, Fever

Scott Yohe, Vice President Market Access at Rigel Pharmaceuticals, says, We are excited to work with Optime Care in the complete management of our Rezlidhia patients.

Key Points: 
  • Scott Yohe, Vice President Market Access at Rigel Pharmaceuticals, says, We are excited to work with Optime Care in the complete management of our Rezlidhia patients.
  • If differentiation syndrome is suspected, withhold REZLIDHIA and initiate treatment with corticosteroids and hemodynamic monitoring until symptom resolution.
  • Of the 25 patients who experienced differentiation syndrome, 19 (76%) recovered after treatment or after dose interruption of REZLIDHIA.
  • Our experience with small patient populations, coupled with our strategic partnership with AscellaHealth , enhances our services and ability to serve the specialty pharmacy market.