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Immunoplate plateplate reduction (ITP) is an autoimmune disease characterized by a small number of plateboards, leading to an increased risk of bruising and bleeding.
estimates that 100 out of every million people have ITP, a condition that is considered chronic when symptoms persist for more than 12 months.
incidence of primary ITP in the adult population is 3.3 per 100,000 people per year.
currently, there is no cure for ITP, and these patients often relapse after receiving various treatments and still need medication to reduce the risk of clinically significant bleeding.
Doptelet's active pharmaceutical ingredient, avatrombopag, is a second-generation, daily oral platelet-promoting platelet-producing perstortor (TPO-RA) that simulates the effects of TPO, the main regulatory factor for normal platelet production.
the United States, Doptelet was approved by the FDA in May 2018 to treat platelet reduction in adult patients with chronic liver disease (CLD) who plan to undergo surgery.
June 2019, the FDA approved the expansion of Doptelet's scope of application for the treatment of platelet reduction in adult patients with chronic immunodeficirative platelet reduction (ITP) who did not respond well to previous therapies.
in the European Union, Doptelet was approved in June 2019 to treat severe platelet reduction in adult CLD patients planning invasive surgery.
Rao, Chief Medical Officer and Head of Research and Development at SOBI, said: "The EU's approval of Doptelet for ITP adaptation is a milestone for ITP patients across Europe.
significant medical needs in the ITP patient population were not met.
this approval is a great opportunity for us to give patients access to a new treatment option.
Doptelet will provide patients and medical professionals with a new oral treatment without any restrictions on the type of food.
" original source: Doptelet ® (avatrombopag) approved in the EU for treatment of ITP
