Is Alofisel FDA approved?
About Alofisel Alofisel was granted orphan drug designation by the European Commission in 2009,12 the U.S. Food and Drug Administration (FDA) in 2017,13 and the Japanese Ministry of Health, Labour and Welfare on March 13, 2019.
Who makes Alofisel?
Alofisel was initially developed by Belgian biopharma TiGenix, was acquired by Takeda for around $600 million in 2018.
What is Alofisel?
Alofisel is a medicine that is used to treat complex anal fistulas in adults with Crohn's disease (an inflammatory condition of the gut) when a conventional or biological medicine has not worked well enough.
What is complex perianal fistulas?
A complex fistula is high (high intersphincteric or high transsphincteric or extrasphincteric or suprasphincteric origin of the fistula tract), may have multiple external openings, may be associated with the presence of pain or fluctuation to suggest a perianal abscess, may be associated with the presence of a ...
What is luminal Crohn's disease?
Luminal Crohn's disease refers to Crohn's disease causing inflammatory changes in the lining, or wall, of the intestine. • Approximately 55 percent of patients with luminal Crohn's disease are symptom free or in remission in any given year.