Rigel Receives EMA Validation of the Marketing Authorization Application for Fostamatinib Disodium Hexahydrate in Chronic ITP in Adult Patients

First SYK inhibitor for the treatment of adult chronic ITP

SOUTH SAN FRANCISCO, Calif., Oct. 11, 2018 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for fostamatinib in adult chronic immune thrombocytopenia. The validation was received on October 4, 2018 and initiated the MAA review process. The company anticipates a decision from the Committee on Human Medicinal Products by the fourth quarter of 2019. Currently, fostamatinib is commercially available in the U.S. under the brand name TAVALISSE™ (fostamatinib disodium hexahydrate), which is the first and only SYK inhibitor indicated for the treatment of thrombocytopenia in adult patients with chronic ITP who have had an insufficient response to a previous treatment.

- From Rigel Press Release

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Five-year-old Wrexham boy with unusual and rare disease takes part in photo project to raise awareness

"Charlie Clarke and his Mum Carrie, from Wrexham, are raising awareness of ITP (Immune Thrombocytopenia) by taking part in the Rare Aware photography project by Mold-based organisation Same but Different.

"It’s important to us that there is more awareness, which is why we wanted to take part in the Rare Aware campaign.

"Knowledge is power. The more people that know about ITP and other rare conditions, the better."

- By Steve Craddock, Chief Reporter, The Leader. Photo Courtesy Ceridwen Hughes.

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International ITP Alliance Members Attend Events

Hike and Seek 2018Global ITP advocacy partners from Denmark, Finland, Netherlands, and New Zealand attended the 18th ITP Conference 2018 for the first time as the International ITP Alliance. The three-day event and scholarship opportunity presented by the Platelet Disorder Support Association (PDSA), offered attendees information on the latest advancements in the diagnosis and treatment of ITP, small group sessions where patients shared their stories, an educational dinner program, a fun-filled hike and seek event and PDSA’s 20th Anniversary celebration at the legendary Rock and Roll Hall of Fame.

ITP Alliance at the 23rd Congress of European Hematology Association

EHA 2018International ITP Alliance members from Denmark, Italy, Sweden and the United States participated in the 23rd Congress of the European Hematology Association (EHA) in Stockholm, Sweden on June 14-17, 2018. It was the largest EHA Congress held to date with more than 11,000 participants from around the world. The program covered every subspecialty in hematology and attendees networked with worldwide experts. This year’s educational and scientific program highlighted state-of-the-art clinical practice, the latest findings in hematology research and other interesting sessions, provided satellite programs and an exhibition organized by pharmaceutical companies.

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PATIENT FILES: ITP

"Derek Elston, trustee of the ITP Support Association, tells PharmaTimes about his experiences of being diagnosed and living with the rare bleeding disorder.

I was first diagnosed in 1993 with ITP after working in the Far East for 14 months. At the end I was fairly shattered both with the intensity of the work and commuting regularly. After about four weeks, I decided to visit the doctor. He took a sample of blood. This was followed by a frantic telephone call at midday. My platelet count was much lower than normal and he arranged for me to see the haematologist consultant at our local hospital. Normally the platelet count should be between 150 and 450, mine was ten!
After asking many questions and another blood sample, he concluded I had been infected with a virus and it had affected my autoimmune system. This he informed was called idiopathic (now immune) thrombocytopenic purpora or ITP for short, a non-malignant bleeding disorder."

- By Selina McKee for PharmaTimes.com

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NOVARTIS' REVOLADE PROVED EFFECTIVE FOR SENIORS

"Novartis Korea said Tuesday additional data analysis from its EXTEND clinical trial for Revolade (ingredient: eltrombopag) proved it safe and effective for those 65 years and older with idiopathic thrombocytopenic purpura (ITP).

The sub-set study findings were presented at the first International Congress of BMT symposium held in Seoul on Aug. 26.

Revolade (known as Promacta in the U.S.) was developed by GlaxoSmithKline (GSK) and transferred to Novartis노바티스 when it acquired the former’s oncology portfolio."

- By Marian Chu, Korea Biomedical Review

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BISHOP SUTTON STUDENT'S WARRIOR SPIRIT

"...Whilst studying for a degree in Stage Management at the Bristol Old Vic Theatre School Megan is aiming to raise £100,000 to support her consultant Dr Charlotte Bradbury and her research team at Bristol Haematology and Oncology Centre in their study of ITP. The team are developing a tracer and blood scanning techniques that will enable them to identify suitable and effective treatments for the individual patients."

- By Selina Cuff, for http://www.chewvalleygazette.co.uk

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GIRL WITH RARE BLOOD DISORDER FORCED TO BEG FOR COSTLY MEDICINE

"...Instead of lying in a hospital bed and receiving medical care, 10-year old Bakhtawar Shafiq, who is suffering from a rare blood disorder, was forced to hold a protest demonstration in front of the Karachi Press Club (KPC) on Tuesday for a medicine that is vital for her survival but very costly and beyond the means of her poor parents.

“Doctors have diagnosed Bakhtawar with chronic immune thrombocytopenia purpura (ITP), which is a bleeding disorder in which the blood doesn’t clot as it should. They have prescribed her tablet Revolade 50mg, whose single tablet costs around Rs3,660,” said the girl’s mother after the demonstration."

By M. Waqar Bhatti.  From thenews.com.pk.

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DOCS RESCUE DENGUE PATIENT WITH RARE BLOOD DISORDER

"...Dengue can lead to unforeseen complications if not diagnosed and treated in time.

A 34-year-old motivational speaker and trainer Anne Anish suffered multiple complications after being gripped by dengue. However, she returned to recovery following constant monitoring by a team of intensivists, doctors and support staff at a city hospital recently.

An underlying medical condition — immune thrombocytopenia (ITP), which she had been living with since childhood, led to rapid deterioration in her health. The blood disorder can lead to excessive bleeding resulting from unusually low levels of platelets — the cells that help blood clot."

- By Umesh Isalkar, The Times of India

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