Astellas-UCB romatoid artrit tedavisi Japonya’da pazarlama onayı aldı (İng)


Astellas-UCB rheumatoid arthritis therapy wins marketing approval in Japan

PBR Staff Writer Published 26 December 2012

Astellas Pharma and UCB have announced the marketing approval of Cimzia (certolizumab pegol) to treat rheumatoid arthritis (RA) in Japan.

The Japanese Ministry of Health, Labor and Welfare has approved Cimzia as a 200mg syringe for subcutaneous (s.c.) injection to treat adult RA patients who failed to respond to conventional treatment.

The only PEGylated Fc-free anti-TNF is designed in the form of a prefilled syringe that enables self-administration by RA patients.

Adult patients can be administered with 400mg s.c. of certolizumab pegol at weeks zero, two and four, subsequent to 200mg every two weeks, while 400mg every four weeks s.c. can be considered for maintenance dosing.

Japanese clinical trials conducted in RA patients demonstrated a significant efficacy and safety profile of certolizumab pegol.