Janssen submits rare blood disease drug for US / EU approval

Janssen Research & Development has announced the simultaneous submissions of a Biologic License Application (BLA) to the US FDA and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for siltuximab for the treatment of patients with multicentric Castleman disease (MCD) who are HIV-negative and human herpes virus-8 (HHV-8)-negative.

MCD is a rare disorder in which lymphocytes, a certain type of white blood cells, are over-produced and lead to enlargement of lymph nodes. There are currently no approved treatments in the US or Europe for this rare blood disease.

Siltuximab has been granted orphan drug status in MCD in the US and EU.

“We’re proud of our work on siltuximab. As a rare disease with a small patient population, MCD is an area of significant unmet need. Siltuximab works by targeting interleukin-6 which appears to be the critical driver of this disease. By focusing on core biologic mechanisms, we now have the potential of helping patients with a condition that is challenging to treat.”

Peter F. Lebowitz, M.D., Ph.D., global oncology therapeutic area head, Janssen.

Janssen’s regulatory submissions for siltuximab include data from a randomized clinical trial and two non-randomized supportive studies. Results of the primary study analysis have been submitted for presentation at a medical meeting later this year.

 

Related news:

Janssen files for EU and US approval of siltuximab (Zenopa)

Reference links:

Janssen press release

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