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Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, September 2021
The EMA’s drug safety committee (PRAC) assessed risks of thrombocytopenia and venous thromboembolism with the Janssen COVID-19 Vaccine.
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immune thrombocytopenia (ITP)
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FDA grants Avatrombopag Orphan Drug Designation for thrombocytopenia
The US FDA has granted avatrombopag (Doptelet) ODD as around 10 percent of US cancer patients per year experience chemotherapy-induced thrombocytopenia (CIT) with no available treatment.
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Revolade shows long-term disease control for immune thrombocytopenia
Novartis has announced long-term study results supporting the positive safety and efficacy of Revolade in adults with chronic/persistent immune thrombocytopenia...
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Rigel submits new drug application to FDA for Fostamatinib in Chronic ITP
18 April 2017 | By Niamh Marriott, Junior Editor
Rigel Pharmaceuticals has submitted a new drug application to the US FDA for fostamatinib in patients with immune thrombocytopenia...
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Rigel’s fostamatinib successfully meets endpoint in chronic ITP trial
30 August 2016 | By Niamh Louise Marriott, Digital Content Producer
The study (n=76) showed that 18% of patients receiving fostamatinib achieved a stable platelet response compared to none receiving a placebo control (p=0.0261)...
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Long-term safety data for Revolade in adults with chronic ITP
10 June 2016 | By Victoria White, Digital Content Producer
Data from the largest study of its kind confirm the long-term safety profile of Novartis’ Revolade in adults with chronic immune thrombocytopenia...
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Amgen’s Nplate shows significant increase in durable platelet response in ITP
21 April 2016 | By Victoria White, Digital Content Producer
A Phase III study shows that 52 percent of Nplate patients achieved a durable platelet response, compared with 10 percent of placebo-treated patients...
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EU approval for Revolade for paediatric patients with chronic ITP
7 April 2016 | By Victoria White
The approval includes the use of a new oral suspension formulation of Revolade designed for younger children who may not be able to swallow tablets...
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Eltrombopag shown to be effective in children with ITP
9 October 2015 | By Victoria White
The study demonstrate that eltrombopag is well tolerated and effective, consistently stabilising the platelet count to over 50 X 109 per litre within 2-6 weeks for 40% of children...
