Rigel’s ITP Drug Fostamatinib Enters Phase 3 Clinical Trial in Japan
Category: #health  By Pankaj Singh  Date: 2019-09-25
  • share
  • Twitter
  • Facebook
  • LinkedIn

Rigel’s ITP Drug Fostamatinib Enters Phase 3 Clinical Trial in Japan

Chronic immune thrombocytopenia (ITP) is a disorder in which the body’s immune system destroys platelets which play a key role in blood clotting and healing. Currently, therapies such as steroids and splenectomy are used to treat ITP. However, patients are not adequately treated with such therapies, thus arising the need for alternative ITP treatment options.

Some advances were made in this field recently when Rigel Pharmaceuticals Inc., a clinical-stage biotechnology company, announced that its partner firm Kissei Pharmaceuticals Co. Ltd., initiated a Phase 3 trial of fostamatinib disodium hexahydrate for treatment of chronic immune thrombocytopenia (ITP) in adult patients.

According to reports, the safety and efficacy of the orally processed drug will be determined by comparing it with placebo in a randomized, double-blind study. Under the brand name TAVALISSE®, fostamatinib is commercially available in the U.S. and is used for treating patients who are suffering from chronic ITP.

Sources claim that the outcomes of this trial will be applied for supporting a new drug application (NDA) which the company is planning to file in late 2021 or early 2022 in Japan. Presently, the European Medicines Agency is reviewing the marketing authorization application for fostamatinib in chronic ITP in adult patients for potential approval in Europe.

For a record, Kissei is a pharmaceutical company in Japan which focuses on patients' unmet medical needs by collaborating with partners as well as by research, development and commercialization. Previously, Kissei offered a Phase 3 trial design to Pharmaceuticals and Medical Devices Agency (PMDA) of Japan and was recently accepted by the agency.

In 2018, Kissei and Rigel collaborated for the commercialization and development of fostamatinib in all current and potential indications in China, Japan, the Republic of Korea and Taiwan.

According to reports, Rigel, under the terms of the deal, received an upfront cash payment of $33 million, with an additional potential for $147 million in commercial and development milestone payment. The company would also receive payments of product transfer price in the range between mid to upper 20% range depending on tiered net sales.

Source Credit – https://ir.rigel.com/news-releases/news-release-details/rigels-fostamatinib-enters-phase-3-clinical-trial-japan-kissei

  • share
  • Twitter
  • Facebook
  • LinkedIn


About Author

Pankaj Singh    

Pankaj Singh

With an experience as an insurance underwriter and a freelance writer under his belt, Pankaj Singh boasts of quite some expertise in the field of content creation. A qualified Post Graduate in Management, Pankaj has also completed a detailed course in Digital Marketin...

Read More

More News By Pankaj Singh

French-Belgian biotech PDC*LINE bags USD 22.2M in a Series B funding
French-Belgian biotech PDC*LINE bags USD 22.2M in a Series B funding
By Pankaj Singh

A clinical stage biotechnology company, PDC*line Pharma, focused upon developing a new class of effective and scalable active immunotherapies for treating cancers, recently announced completion of a Series B round of funding. The company ha...

VMware plans to acquire Nyansa to expand its SW-WAN portfolio
VMware plans to acquire Nyansa to expand its SW-WAN portfolio
By Pankaj Singh

  The deal for the acquisition will close in the first quarter of the FY2021 The terms of the deal have not been disclosed by the company yet VMware, a leading provider of virtualization and cloud computing software and services, recently ...

Rogers Communications launches 5G network services across Canada
Rogers Communications launches 5G network services across Canada
By Pankaj Singh

  The network will first be implemented in Toronto, Vancouver, Montreal and Ottawa Rogers has collaborated with Ericsson to provide the required technology to develop the network Rogers Communications – a Toronto based telecommunicat...