Scopulariopsis

Orphan designation: Olorofim Treatment of invasive Scopulariopsis, 14/01/2022 Positive

Retrieved on: 
Tuesday, April 9, 2024
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Overview

Key Points: 
  • Overview
    This medicine was designated as an orphan medicine for the treatment of invasive Scopulariopsis in the European Union on 14 January 2022.
  • All medicines, including designated orphan medicines, must be authorised before they can be marketed and made available to patients in the EU.
  • The full list of orphan designations is available in the Community register of orphan medicinal products for human use.
  • EU register of orphan medicines
    The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:

F2G and Shionogi Present Full Data Set from Pivotal Phase 2b Study at Trends in Medical Mycology (TIMM) 2023 Demonstrating Positive Therapeutic Responses in Patients with Invasive Fungal Infections Treated with Oral Olorofim

Retrieved on: 
Saturday, October 21, 2023
Standard of care, TIMM, Immunodeficiency, Congress, MD, EORTC, Doctor of Philosophy, Fungus, Research, Coccidioidomycosis, DRC, Shionogi, UZ Leuven, Hematology, OASIS, Scopulariopsis, World Health Organization, Risk, Antifungal, Medical Mycology, ACM, Fungal infection, Goodyear F2G Corsair, Patient, Infection, Birth control, Pharmaceutical industry, Coccidioides, F2G

These findings were submitted as a late breaking abstract and exceptionally accepted for an oral presentation during the 11th Congress on Trends in Medical Mycology (TIMM) 2023 held in Athens, Greece, from 20-23 October 2023.

Key Points: 
  • These findings were submitted as a late breaking abstract and exceptionally accepted for an oral presentation during the 11th Congress on Trends in Medical Mycology (TIMM) 2023 held in Athens, Greece, from 20-23 October 2023.
  • F2G and Shionogi & Co., Ltd. are collaborating to develop and commercialise olorofim, bringing the novel antifungal therapy to patients with invasive fungal infections.
  • F2G has commercial responsibility for olorofim in North America, and Shionogi has commercial responsibility for olorofim in Europe and Asia Pacific.
  • F2G and Shionogi are currently enrolling patients with invasive aspergillosis in a global Phase 3 study (OASIS) to compare treatment with olorofim versus AmBisome® followed by standard of care ( NCT05101187 ).

F2G Announces FDA Filing Acceptance of New Drug Application for Olorofim for the Treatment of Invasive Fungal Infections

Retrieved on: 
Monday, December 19, 2022
Fungus, Disease, PDUFA, Scopulariopsis, Food, Mycosis, MD, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Antibiotic, File, NDA, DHODH, Patient, Mortality, Aspergillosis, Prescription Drug User Fee Act, FDA, Breakthrough therapy, Coccidioides, New Drug Application, Pharmaceutical industry, F2G

F2G has requested approval of the NDA under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD pathway) for a limited, well-defined population with invasive fungal infections and limited or no treatment options.

Key Points: 
  • F2G has requested approval of the NDA under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD pathway) for a limited, well-defined population with invasive fungal infections and limited or no treatment options.
  • Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of June 17, 2023.
  • “Invasive fungal infections cause substantial morbidity and mortality, particularly among immunosuppressed patients, and can prove to be lethal in also healthy individuals when they get into deeper tissues.
  • If approved, olorofim will be the first of a new class of antifungal drugs.”
    Olorofim is the only antifungal medication to be awarded Breakthrough Therapy Designation by the FDA.

F2G Announces Data from Phase 2b Study at ID Week 2022 Showing Positive Therapeutic Response in Patients with Invasive Fungal Infections Treated with Olorofim

Retrieved on: 
Friday, October 21, 2022
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Approximately 75% of patients in this analysis had moderate to high levels of immunosuppression, with about half suffering from fungal infections due to Aspergillus.

Key Points: 
  • Approximately 75% of patients in this analysis had moderate to high levels of immunosuppression, with about half suffering from fungal infections due to Aspergillus.
  • Data came from 100 patients with proven invasive fungal infection or probable pulmonary invasive aspergillosis (IA).
  • Mortality remains unacceptably high in patients with severe and life-threatening fungal infections being treated with currently available therapies.
  • Olorofim has been granted Qualified Infectious Disease Product (QIDP) designation for invasive aspergillosis, invasive scedosporiosis, invasive lomentosporiosis, coccidioidomycosis, invasive disease due to Scopulariopsis species, and invasive fusariosis.

F2G to Present Interim Results from Phase 2B Open Label Study of Olorofim in Invasive Fungal Infections at IDWeek 2022

Retrieved on: 
Thursday, October 13, 2022
European Medicines Agency, Immunology, Disease, G.H. Raisoni Department of Microbiology and Biotechnology, SOC, Infection, QIDP, Mycosis, Gambat Liver Transplant Unit, Patient, Hematology, Standard of care, Inhalation, Comparison, Mortality, Coccidioidomycosis, Internal medicine, IFI, Company, Department, Transplant, OLO, Safety, GLOBE, Aspergillosis, Antifungal, FDA, UZ Leuven, Human, Pharmaceutical industry, Dentistry, Scopulariopsis, Coccidioides, KU Leuven, Aspergillus

The Company will also present posters on pharmacokinetic data from Phase 1 and Phase 2B studies of olorofim antifungal therapy.

Key Points: 
  • The Company will also present posters on pharmacokinetic data from Phase 1 and Phase 2B studies of olorofim antifungal therapy.
  • Olorofim has received orphan drug status from the European Medicines Agency for the treatment of invasive aspergillosis and invasive scedosporiosis.
  • Olorofim has been granted Qualified Infectious Disease Product (QIDP) designation for invasive aspergillosis, invasive scedosporiosis, invasive lomentosporiosis, coccidioidomycosis, invasive disease due to Scopulariopsis species, and invasive fusariosis.
  • Invasive aspergillosis is a rare disease that can occur in over 10% of some high-risk immunosuppressed populations with mortality exceeding 80%.

Forbion Co-leads $70 Million Financing of F2G to Advance Development and Commercialization of New Antifungal Agent Olorofim

Retrieved on: 
Thursday, August 4, 2022
Human, European Medicines Agency, United Nations Principles of Medical Ethics, Standard of care, BGV, ERP, LFA, Socially responsible investing, DVI, Patient, European Recovery Plan, QIDP, Marshall Plan, SOC, FDA, Disease, EIF, Infection, EUR, Inhalation, Investment, The Programme, Coccidioidomycosis, Health, Antifungal, EFSI, Mycosis, Mortality, Aspergillosis, Pharmaceutical industry, Aspergillus, Scopulariopsis

Forbion manages well over EUR 2 billion across multiple fund strategies that cover all stages of (bio-) pharmaceutical drug development.

Key Points: 
  • Forbion manages well over EUR 2 billion across multiple fund strategies that cover all stages of (bio-) pharmaceutical drug development.
  • Forbion operates a joint venture with BGV, the manager of seed and early-stage funds, especially focused on Benelux and Germany.
  • Olorofim has received orphan drug status from the European Medicines Agency for the treatment of invasive aspergillosis and invasive scedosporiosis.
  • Olorofim has also received orphan drug status from the FDA for the treatment of coccidioidomycosis scedosporiosis, and invasive aspergillosis.