WEP Clinical LTD (WEP), a specialist services company that works with drug developers to help patients and physicians gain early access to medicines when no other treatment options are available, has partnered with Japan-based Global Specialty Pharmaceutical company, Kyowa Kirin, to launch a Post-Approval Named Patient Program (PA-NPP) for CRYSViTA® (burosumab).
CRYSViTA® is a fibroblast growth factor 23 (FGF23)–blocking monoclonal antibody indicated for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 1 year of age and older and for a tumour-induced osteomalacia (TIO) associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized in adults and children and adolescents aged 1 to 17 years.
The PA-NPP is designed to ensure that physicians in the following countries in the Asia Pacific region, Bangladesh, Bhutan, Brunei, Cambodia, East Timor, India, Myanmar, Nepal, New Zealand, Palau, Papa New Guinee, Philippines, Sri Lanka and Vietnam, can request CRYSViTA® on behalf of individual patients who reside in countries where CRYSViTA® is not currently commercially available and who have been diagnosed with XLH or TIO, rare, chronic progressive musculoskeletal disorders that affect both adults and children.
Jas Khera, Managing Director of WEP, said:
“We are grateful to partner with Kyowa Kirin to help ensure broader access to this important treatment option for patients affected by XLH and TIO. Kyowa Kirin has already achieved some important clinical results with CRYSViTA®, and the WEP Clinical team is looking forward to helping make this treatment available to patients in a number of countries in the Asia Pacific region.”
For physicians who are interested in further information on the CRYSViTA® PA-NPP, please contact: firstname.lastname@example.org.
At WEP Clinical, we are With Every Patient, as we believe every patient should have access to treatment! With this as our guiding principle, we have created a market leading, solutions driven, healthcare services company that partners with drug developers to create broader treatment access solutions for patients worldwide. We take pride in the high-quality output and positive customer experience we create while delivering our services. We specialize in the following: Expanded Access and Post-Approval Named Patient Programs; Market Access Solutions; Home Nursing Services for Decentralized Clinical Trials; and Clinical Trial Sourcing. For more information, please visit www.wepclinical.com.
About Kyowa Kirin
Kyowa Kirin strives to create and deliver novel medicines with life-changing value. As a Japan-based Global Specialty Pharmaceutical Company with a heritage of more than 70 years, the company applies cutting-edge science, including expertise in antibody research and engineering, to address the needs of patients across multiple therapeutic areas such as nephrology, oncology, immunology/allergy and neurology. Across its four regions – Japan, Asia Pacific, North America and EMEA/International – Kyowa Kirin focuses on its purpose, to make people smile, and is united by its shared values of commitment to life, teamwork, innovation and integrity. Learn more about the Company at www.kyowakirin.com.
About CRYSViTA® (burosumab)
CRYSViTA® (burosumab) is a breakthrough therapy in the treatment of patients with X-linked hypophosphatemia (XLH) or tumor-induced osteomalacia (TIO), which addresses the underlying cause of the disease. It is a recombinant fully human monoclonal lgG1 antibody against the phosphaturic hormone fibroblast growth factor 23 (FGF23). It works by increasing phosphate reabsorption in the kidney and the production of vitamin D, which enhances intestinal absorption of phosphate and calcium in XLH and TIO patients.
CRYSViTA® is the first and only approved therapy for the treatment of XLH and TIO.
The first EU approval in February 2018 granted a conditional marketing authorization for CRYSViTA® for the treatment of XLH with radiographic evidence of bone disease in children one year of age and older and adolescents with growing skeletons. In October 2020, this authorization was subsequently expanded to include older adolescents and adults. Since August 2022, CRYSViTA® has been indicated in the EU for the treatment of FGF23-related hypophosphatemia in TIO associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized in children and adolescents aged 1 to 17 years and in adults, as well as for XLH in adults and children and adolescents aged 1 to 17 years with radiographic evidence of bone disease.
CRYSVITA® was approved in the US in April 2018 for patients with XLH aged one year and older. In June 2020, the US approved CRYSViTA® for patients aged two and older with tumor-induced osteomalacia.