EQS-News

Biotest AG: Biotest receives approval for innovative immunoglobulin Yimmugo in the UK

EQS-News: Biotest AG / Key word(s): Regulatory Approval Biotest AG: Biotest receives approval for innovative immunoglobulin Yimmugo in the UK 21.09.2023 / 09:00 CET/CEST The issuer is solely responsible for the content of this announcement.

PRESS RELEASE

 

 

Biotest receives approval for innovative immunoglobulin Yimmugo in the UK

 

• New approval enables future sales growth
• Important therapeutic option for paediatric and adult patients with congenital and acquired immunodeficiencies as well as for immunomodulation
• Manufactured in highly efficient Biotest Next Level production facility in Germany

 

Dreieich, 21 September 2023. Biotest AG announced today that its intravenous immunoglobulin Yimmugo (IgG Next Generation) has now also received approval in the United Kingdom for the treatment of patients with congenital and acquired immunodeficiencies and for immunomodulation, following approvals in Germany and Austria.

"We are delighted that this approval gives us the opportunity to launch our new immunoglobulin in another important European market," said Enrico D'Aiuto, Senior Vice President, Head of Global Sales and Marketing. "This will help us to meet the growing demand for immunoglobulin therapies, provide even more patients with our new immunoglobulin and thus contribute to improving their quality of life."

The new immunoglobulin is the first product to be manufactured using an innovative process in the new "Biotest Next Level" production facility at the Dreieich site. It has been investigated in extensive approval studies for safety, efficacy and tolerability. The UK market launch is possible with immediate effect.

 

 

 

 

 

About Yimmugo (IgG Next Generation)

Yimmugo is a newly developed polyvalent immunoglobulin G preparation from human blood plasma for intravenous administration (IVIg). The sugar-free ready-to-use solution is approved for substitution therapy in primary antibody deficiency syndromes and secondary immune deficiency, as well as for immunomodulation in autoimmune diseases such as ITP, GBS, CIDP, MMN and Kawasaki syndrome. Yimmugo is the first approved product from the new Biotest Next Level production facility. The modern production process stands for highest product quality and an extremely responsible use of resources.