Clinigen
20 December 2022
Clinigen initiates a Managed Access Program for relugolix in Europe for the attraction of advanced hormone-sensitive prostate cancer
Clinigen Limited (‘Clinigen’), the planetary pharmaceutical and services company, has entered into an statement with Accord Healthcare (‘Accord’) to initiate a Managed Access Program successful Europe for relugolix (ORGOVYX®).
Relugolix was granted support by the European Medicines Agency (EMA) successful April 2022 for the attraction of big patients with precocious hormone-sensitive prostate cancer. The support is applicable successful circumstantial European countries and is the archetypal oral androgen deprivation attraction available.
Prostate crab is the astir communal crab successful men accounting for 23% of caller cases successful Europe successful 2020 and the 3rd astir communal origin of cancer-related decease successful men, aft lung and colorectal cancers.1,2
The Managed Access Program is designed to let entree to relugolix for selected candidates who are not eligible oregon capable to enactment successful a objective proceedings oregon successful a state wherever reimbursement is yet to beryllium approved by respective healthcare authorities. Clinigen’s Unlicensed Medicines concern volition supply relugolix to patients successful circumstantial European countries until the medicine is disposable done mean commercialized channels.
Suzanne Aitken, SVP Managed Access, Clinigen Group said:
“Clinigen is proud to grow our longstanding partnership with Accord to guarantee that eligible patients with precocious hormone-sensitive prostate crab volition present beryllium capable to summation entree to this caller and important medicine.”
Healthcare professionals tin get details astir the relugolix Managed Access Program by calling the Clinigen medicine entree squad astatine +44 1283 494 340 oregon emailing medicineaccess@clinigengroup.com.
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Contact details
Clinigen Group Ltd. | +44 (0) 20 3907 0830 | ||
Michelle Shearly, Director of Communications | michelle.shearly@clinigengroup.com | ||
Consilium Strategic Communications |
Notes to Editors
About Clinigen
Clinigen is simply a global, specializer pharmaceutical services institution focused connected providing ethical entree to medicines. Its ngo is to present the close medicine to the close diligent astatine the close time. The Group operates from sites successful North America, Europe, Africa and the Asia Pacific. Clinigen has much than 1,000 employees crossed 5 continents successful 15 countries, with proviso and organisation hubs and operational centres of excellence successful cardinal semipermanent maturation regions. The Group works with 32 of the apical 50 pharmaceutical companies providing entree crossed much than 120 countries.
For much accusation connected Clinigen, delight sojourn http://www.clinigengroup.com
About Accord Healthcare
Accord Healthcare is 1 of the fastest increasing pharmaceutical companies successful Europe. Accord has 1 of the largest marketplace footprints of immoderate European generic and biosimilars companies, selling generic medicines successful implicit 80 countries astir the world.
Since Accord’s accomplishment into Europe successful 2008, arsenic the planetary limb of Intas Pharmaceuticals Ltd, their superior absorption has been to guarantee that patients person entree to precocious prime medicines astatine the constituent of need. Accord person dynamically evolved from their practice successful generics and biosimilars to go experts successful speciality and value-added medicines with 4 cornerstone franchises: Oncology & Haematology, Autoimmune, CNS and Critical Care.
About relugolix (ORGOVYX®)
ORGOVYX® (relugolix, 120 mg) is indicated successful Europe for the attraction of big patients with precocious hormone-sensitive prostate cancer. As a gonadotropin-releasing hormone (GnRH) receptor antagonist ORGOVYX® blocks the GnRH receptor and reduces accumulation of testicular testosterone, a hormone known to stimulate the maturation of prostate cancer.
About Prostate Cancer
In 2020, the full fig of men in Europe with prostate crab was astir 1.4 cardinal according to the World Health Organization.3
Prostate crab is considered precocious erstwhile it has dispersed beyond the prostate, is localized to the prostate and improbable to beryllium cured by country oregon radiation oregon has comeback aft archetypal attraction and cannot beryllium treated with salvage surgery. Front-line aesculapian therapy for precocious prostate crab typically involves androgen deprivation therapy, which reduces testosterone to precise debased levels, commonly referred to arsenic castrate levels (< 50 ng/dL). Luteinizing hormone-releasing hormone (LHRH) receptor agonists, specified arsenic leuprolide acetate, are depot injections and the existent modular of attraction for androgen deprivation therapy. LHRH agonists are associated with an archetypal surge successful testosterone levels that whitethorn exacerbate objective symptoms successful immoderate patients and delayed testosterone betterment aft the cause is discontinued owed to their depot injection formulation.
References
¹,² Health astatine a Glance: Europe 2020: State of Health successful the EU Cycle, OECD Publishing, Paris, https://doi.org/10.1787/429ff2a5-en
³ https://gco.iarc.fr/today/data/factsheets/cancers/27-Prostate-fact-sheet.pdf
Orgovyx® is simply a registered trademark of Accord Healthcare
English (US)