LEDAGA® (Chlormethine hydrochloride) – TGA APPROVAL
Accelagen, a Melbourne based Regulatory Affairs, Clinical Research and Development Organisation, are pleased to be an integral part of the approval of LEDAGA® by the Therapeutic Goods Administration (TGA) on behalf of the Australian office of Recordati Rare Diseases.
LEDAGA, indicated for the topical treatment of mycosis fungoides-type cutaneous T-cell lymphoma (MF-type CTCL) in adult patients, was recently granted regulatory approval in Australia, after earlier obtaining Orphan Drug Designation (ODD) for the same indication. The decision was based on an extensive submission of quality, nonclinical and clinical data prepared and submitted by the Accelagen regulatory team on behalf of our valued client. The regulatory submission was a culmination of the expertise and strategic input provided by Accelagen, Recordati Rare Diseases and their commercial partner.
Greg Plunkett, Founder and Managing Director of Accelagen notes that “This approval signifies an exciting development for not only Accelagen and Recordati Rare Diseases Australia, but for those patients this therapy seeks to help. On behalf of the team at Accelagen, this is another meaningful contribution to our industry and one we are proud of. I’d like to thank our partner Recordati and more importantly the team who have diligently driven this project from inception in mid-2019 through to approval. We look forward to following the progress and outcomes of this specific product and to future products with Recordati Rare Diseases.”
Tony Shelton, General Manager of Recordati Rare Diseases Australia adds “We’ve had a highly engaged and productive partnership with Accelagen to bring this product to this stage. The team at Accelagen have delivered a program that has not only been effective but efficient, and we look forward to exploring future endeavours with them.
For more information about this project or Accelagen please visit www.accelagen.com.au or contact the office on +61 3 9114 2270
Accelagen, an Australian based Regulatory Affairs, Clinical Research and Development organisation, are a highly successful, effective and committed Contract Research Organisation (CRO) working with an array of local and international clients.
Founded in 2010, Accelagen’s growth allowed it to expand their services and expertise to facilitate the development of novel pharmaceutical and medical device products from concept to commercialization. Accelagen’s unique skills and expertise are highly sought by clients seeking the right partner in Australia and have elevated Accelagen to become a CRO of choice. With a focus on client’s objectives first and foremost, Accelagen deliver strategies to achieve goals in a time and cost-effective way, while minimizing the time required on a project by combining key specialist skills within one organisation.
About Recordati Rare Diseases
Recordati, established in 1926, is an international pharmaceutical group, listed on the Italian Stock Exchange, with a total staff of more than 4,300, dedicated to the research, development, manufacturing and marketing of pharmaceuticals. Headquartered in Milan, Italy, Recordati has operations in Europe, Russia and the other C.I.S. countries, in Ukraine, Turkey, North Africa, the United States of America, Canada, Mexico, some South American countries, Japan and Australia. An efficient field force of medical representatives promotes a wide range of innovative pharmaceuticals, both proprietary and under license, in several therapeutic areas including a specialized business dedicated to treatments for rare diseases. Recordati Rare Diseases is a partner of choice for new product licenses for its territories. Recordati Rare Diseases is committed to the research and development of new specialties with a focus on treatments for rare diseases.
® LEDAGA is a registered trademark of Helsinn Healthcare S.A.