New drug for plate plate plate reduction! The second generation of oral platelet-promoting pigment-producing agent Doptelet is about to be approved in the European Union!

December 16, 2020 // -- Swedish pharmaceutical company Swedish Orphan Biovitrum AB (SOBI) recently announced that the European Medicines Agency (EMA) Commission on Human Pharmaceutical Products (CHMP) has issued an active review. Approval is recommended to expand the scope of doptelet (avatrombopag) for the treatment of primary chronic immunoploid reduction (ITP) adult patients who are ineffective with other treatments such as corticosteroids and immunoglobulins.
, CHMP's comments will now be submitted to the European Commission, which usually makes a final review decision within two months.
immune plateboard 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 usually 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 thyroid-producing perstortor (TPO-RA) that simulates the effects of TPO, the main regulatory factor for normal platelet production.
U.S., 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 have not responded well to previous treatments.
in the European Union, Doptelet was approved in June 2019 to treat severe platelet reduction in adult CLD patients planning invasive surgery.
News is an important step towards providing treatment options to ITP patients in Europe," said Ravi Rao, chief medical officer and head of research and development at SOBI.
's positive comments today are an important milestone for ITP patients across Europe.
if approved by the European Commission, Doptelet will provide patients and medical experts with a new oral treatment without any restrictions on the type of food.
" () Original source: European advisory group backs SOBI's Gilead's Doptelet in thrombocytopenia