Onspira’s bronchiolitis obliterans treatment secures FDA orphan drug status
BO is a progressive inflammatory condition resulting in airflow obstruction and loss of function in the lung and is considered a form of chronic rejection. There are no
China’s National Medical Products Administration (NMPA) has granted marketing authorisation for Bio-Thera Solutions’ BAT2506 to treat ankylosing spondylitis and rheumatoid arthritis.
Onpattro is claimed to be the first-of-its-kind RNAi therapeutic and only FDA-approved treatment for this indication. Earlier, Onpattro secured breakthrough therapy and orphan drug designations from the FDA.