Bio Products Laboratory (BPL), a leading manufacturer of plasma-derived protein therapies, based in Elstree, UK, announced today the issuance of a marketing authorization for Coagadex® in the Dominican Republic.
Coagadex® is the first and only specific treatment for Hereditary Factor X Deficiency, an ultra-rare inherited clotting disorder, affecting up to 1 in a million people worldwide. The disease causes problems with blood clotting due to not having enough Factor X in the blood, and people with Factor X Deficiency can have serious and life-threatening bleeding episodes.
The treatment is critical to meet the increasing needs of patients in the region, with a population of 10.8 million, the Dominican Republic is the tenth largest economy in Latin America. The approval is also timely, as only two months ago, the protocol was updated in the country for the treatment of paediatric and adult Haemophilia, including Hereditary Factor X Deficiency.
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This is the first marketing authorization for BPL in Central America and the Caribbean, and with a robust strategic expansion plan in motion, the company expects this to be the first of many countries in the region to receive marketing authorization.
It also follows some key milestones for BPL this past year who received two marketing authorizations for Coagadex®, firstly in India last September, followed by Mexico in May.
Bob Rossilli, Chief Commercial Officer, Global Business, said, “We are delighted by this approval, which means we can soon provide patient communities in the Dominican Republic with Coagadex® – the only treatment specifically for Hereditary Factor X Deficiency.
This authorization and our recent approvals in India and Mexico for Coagadex®, reflects our plans for expansion in Central America and across the world. It also highlights our corporate mission of providing a continuous supply of plasma-derived products worldwide to support healthcare professionals and patients every day.”
Thank you to our distributor, Bioplus Care, and all those involved, for the great collaborative work during a long journey to make another success happen for patients in the Dominican Republic and around the world.”
Stephanie Waserstein, Head of BioPlus Care, said, “It is extremely satisfying for BioPlus Care to have partnered with BPL, a truly patient centred company, committed to making its therapies available in all parts of the world where patients need them.”