Trophozoite

SIFI ANNOUNCES EMA VALIDATION OF ITS MARKETING AUTHORISATION APPLICATION FOR AKANTIOR® FOR THE TREATMENT OF ACANTHAMOEBA KERATITIS AND THE OPENING OF AN EARLY ACCESS PROGRAM

Retrieved on: 
Tuesday, June 7, 2022
Severe cognitive impairment, Marketing, Leadership, Eye, Company, Acanthamoeba keratitis, Research, EMA, EC, UCL Institute of Ophthalmology, Standard of care, Transplant, University College London, Disease, CEO, Committee, European Directive on Traditional Herbal Medicinal Products, Partnership, Trophozoite, CHMP, Medicines and Healthcare products Regulatory Agency, Patient, Fungal keratitis, SIFI, EAPS, Committee for Medicinal Products for Human Use, Polyhexanide, Phase, Medication, Incidence, Quality of life, European Medicines Agency, Royal commission, European Commission, Drug development, West Pharmaceutical Services, Marketing Authorisation Application, Institute, AK, Cyst, Medical device, Pharmaceutical industry, Acanthamoeba, Ophthalmology

"We are incredibly pleased to be working in partnership with SIFI on this important access program," said Dan Piggott, Managing Director of Uniphar Group's Product Access Division.

Key Points: 
  • "We are incredibly pleased to be working in partnership with SIFI on this important access program," said Dan Piggott, Managing Director of Uniphar Group's Product Access Division.
  • "We look forward to helping facilitate broader access to polihexanide for patients with critical unmet medical needs suffering from acanthamoeba keratitis."
  • AKANTIOR (polihexanide) stands to become the first approved drug for the treatment of acanthamoeba keratitis in the world.
  • Polihexanide is also being developed by SIFI for the treatment of fungal keratitis for which indication it also has FDA Orphan Drug Designation.

SIFI ANNOUNCES EMA VALIDATION OF ITS MARKETING AUTHORISATION APPLICATION FOR AKANTIOR® FOR THE TREATMENT OF ACANTHAMOEBA KERATITIS AND THE OPENING OF AN EARLY ACCESS PROGRAM

Retrieved on: 
Tuesday, June 7, 2022
Severe cognitive impairment, Marketing, Leadership, Eye, Company, Acanthamoeba keratitis, Research, EMA, EC, UCL Institute of Ophthalmology, Standard of care, Transplant, University College London, Disease, CEO, Committee, European Directive on Traditional Herbal Medicinal Products, Partnership, Trophozoite, CHMP, Medicines and Healthcare products Regulatory Agency, Patient, Fungal keratitis, SIFI, EAPS, Committee for Medicinal Products for Human Use, Polyhexanide, Phase, Medication, Incidence, Quality of life, European Medicines Agency, Royal commission, European Commission, Drug development, West Pharmaceutical Services, Marketing Authorisation Application, Institute, AK, Cyst, Medical device, Pharmaceutical industry, Acanthamoeba, Ophthalmology

"We are incredibly pleased to be working in partnership with SIFI on this important access program," said Dan Piggott, Managing Director of Uniphar Group's Product Access Division.

Key Points: 
  • "We are incredibly pleased to be working in partnership with SIFI on this important access program," said Dan Piggott, Managing Director of Uniphar Group's Product Access Division.
  • "We look forward to helping facilitate broader access to polihexanide for patients with critical unmet medical needs suffering from acanthamoeba keratitis."
  • AKANTIOR (polihexanide) stands to become the first approved drug for the treatment of acanthamoeba keratitis in the world.
  • Polihexanide is also being developed by SIFI for the treatment of fungal keratitis for which indication it also has FDA Orphan Drug Designation.

SIFI RECEIVES FAVORABLE FEEDBACK FROM THE US FDA ON AKANTIOR® FOR THE TREATMENT OF ACANTHAMOEBA KERATITIS

Retrieved on: 
Monday, May 16, 2022
Company, Disease, Polyhexanide, Acanthamoeba keratitis, Eye, Incidence, NCE, Cyst, Patient, Quality of life, Severe cognitive impairment, SIFI, Research, Patent, FDA, Trophozoite, Massachusetts Eye and Ear, Transplant, University, Orphan, NDA, American Journal, Illinois Eye and Ear Infirmary, AK, The Company, Ophthalmology, MD, Fungal keratitis, CEO, Pharmaceutical industry, Acanthamoeba, New chemical entity

ABOUT AKANTIOR: AKANTIOR (polihexanide) stands to become the first approved drug for the treatment of acanthamoeba keratitis in the world.

Key Points: 
  • ABOUT AKANTIOR: AKANTIOR (polihexanide) stands to become the first approved drug for the treatment of acanthamoeba keratitis in the world.
  • Polihexanide is also being developed by SIFI for the treatment of fungal keratitis for which indication it also has FDA Orphan Drug Designation.
  • ABOUT Acanthamoeba Keratitis (AK): AK is a rare, acute, severe parasitic corneal infection caused by Acanthamoeba, a free-living amoeba.
  • ABOUT SIFI: SIFI is a leading international ophthalmic company, headquartered in Italy, focusing on eye care since 1935.

SIFI RECEIVES FAVORABLE FEEDBACK FROM THE US FDA ON AKANTIOR® FOR THE TREATMENT OF ACANTHAMOEBA KERATITIS

Retrieved on: 
Monday, May 16, 2022
Company, Disease, Polyhexanide, Acanthamoeba keratitis, Eye, Incidence, NCE, Cyst, Patient, Quality of life, Severe cognitive impairment, SIFI, Research, Patent, FDA, Trophozoite, Massachusetts Eye and Ear, Transplant, University, Orphan, NDA, American Journal, Illinois Eye and Ear Infirmary, AK, The Company, Ophthalmology, MD, Fungal keratitis, CEO, Pharmaceutical industry, Acanthamoeba, New chemical entity

ABOUT AKANTIOR: AKANTIOR (polihexanide) stands to become the first approved drug for the treatment of acanthamoeba keratitis in the world.

Key Points: 
  • ABOUT AKANTIOR: AKANTIOR (polihexanide) stands to become the first approved drug for the treatment of acanthamoeba keratitis in the world.
  • Polihexanide is also being developed by SIFI for the treatment of fungal keratitis for which indication it also has FDA Orphan Drug Designation.
  • ABOUT Acanthamoeba Keratitis (AK): AK is a rare, acute, severe parasitic corneal infection caused by Acanthamoeba, a free-living amoeba.
  • ABOUT SIFI: SIFI is a leading international ophthalmic company, headquartered in Italy, focusing on eye care since 1935.

SIFI Announces Positive Topline Results of the Pivotal Phase III Study of Polihexanide for the Treatment of Acanthamoeba Keratitis

Retrieved on: 
Tuesday, October 19, 2021
Marketing, Caregiver, European Directive on Traditional Herbal Medicinal Products, University College London, Adequate Yearly Progress, Acanthamoeba keratitis, Institute, AK, Trophozoite, Transplant, Patient, European Medicines Agency, MAA, Incidence, EMA, SIFI, Disease, III, UCL Institute of Ophthalmology, FDA, Quality of life, CEO, Medicine, Phase, Severe cognitive impairment, Cyst, Food, Physician, Safety, Pharmaceutical industry

CATANIA, Italy, Oct. 19, 2021 /PRNewswire/ -- SIFI, a leading international ophthalmic company, announced today that the pivotal Phase III study on polihexanide 0,08% monotherapy in adults and adolescents with Acanthamoeba keratitis (AK), met its primary endpoint of 'clinical resolution rate over a 12-month timeframe'. It also demonstrated an encouraging safety and tolerability profile. Based on these results, SIFI will request an accelerated assessment and plans to file a Marketing Authorisation Application (MAA) at the European Medicines Agency (EMA) for polihexanide 0,08% monotherapy under the Centralised Procedure for Orphan-Designated Medicinal Products in the first half of 2022.

Key Points: 
  • - Polihexanide would become the first approved drug for the treatment of Acanthamoeba Keratitis, a rare, sight-threatening parasitic eye infection.
  • With these trial results, polihexanide could become the first approved drug for the treatment of AK anywhere in the world.
  • The Phase III data give us clarity that monotherapy with polihexanide 0,08% will effectively address this unmet medical need.
  • Both treatment arms have used a novel standardized treatment protocol It is the first-ever Phase III study for an investigational medicine performed for AK.