Mabion obtained ODD status from the FDA for MabionCD20 in another indication

Mabion has been granted orphan drug (ODD) status by the U.S. Food and Drug Administration (FDA) for MabionCD20 in the indication of autoimmune hemolytic anemia (AIHA), the company announced. The ODD status is granted to drugs to prevent and treat rare diseases, and provides biotechnology companies with a number of incentives to support the development of diagnostics and therapies.


“After obtaining in January this year. ODD status for MabionCD20 in the indication of membranous nephropathy, we inform you about another positive FDA decision for the company, granting us the ODD status in the indication of autoimmune hemolytic anemia. I would like to draw your attention to the fact that MabionCD20 is historically only the second rituximab-type compound to obtain this status in the AIHA indication. Possible proceeding of the project in this indication in the mode reserved for orphan drugs is associated with the possibility of obtaining a number of benefits at the cost and business level. (…),” said Sławomir Jaros, Member of the Management Board for Operations and Science, quoted in the release.

MabionCD20 is a monoclonal antibody, a drug biosimilar to MabThera/Rituxan (rituximab), and its mechanism of action means that it is used in many therapeutic indications, including numerous rare and autoimmune diseases, which at the same time increases the attractiveness of this drug for pharmaceutical companies.

“The orphan drug status obtained by MabionCD20 in just two indications increases the attractiveness of the project according to several scenarios we have analyzed. When work on the company’s long-term development strategy is completed, we will be able to more precisely define the possible paths for the MabionCD20 project,” added Adam Pietruszkiewicz, Member of the Management Board for Sales.

Autoimmune haemolytic anemia (AIHA) is a severe autoimmune disorder in which the patient’s antibodies attack his own red blood cells (red blood cells), causing them to break down and reduce the oxygen-carrying capacity of the blood.

Mabion is an integrated Polish biopharmaceutical company whose main area of activity is the development of the latest generation of drugs based on recombinant protein technology (e.g. monoclonal antibodies). In 2010, Mabion entered the NewConnect market, and in 2013 the company moved to the main floor of the Warsaw Stock Exchange.

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