Please login to the form below

Not currently logged in
Email:
Password:

Astellas withdraws drug application in Japan

Astellas Pharma has withdrawn the marketing application for its venous thromboembolism preventative darexaban in Japan

Astellas Pharma has withdrawn the marketing application for its venous thromboembolism preventative darexaban in Japan, the first market in which it had filed the drug.

The marketing application, which was submitted in late September 2010, had been seeking approval of the oral Factor Xa direct inhibitor for the prevention of venous thromboembolism (VTE) in patients at risk, such as those undergoing orthopaedic surgical procedures in the lower limbs.

Astellas said it was withdrawing the application based on feedback from Japanese regulators that additional clinical trials would be required before the drug could be approved. The marketing application contained two phase II/III studies that compared darexaban to placebo in patients who had elective total knee or hip replacement surgeries in Japan and other Asian countries.

In addition, a North American phase II study for VTE prevention in patients after elective primary knee arthroplasty demonstrated dose-dependent efficacy in VTE prevention, according to the company.

Astellas said it will seek a partner for the development and commercialisation of darexaban for the VTE indication in the US and Europe and for an indication of stroke prevention in atrial fibrillation globally. "Astellas expects to decide future plans, including the indication of VTE in Japan, based on the outcome of the partnership discussion," the company noted.

Darexaban, which was discovered and developed by Astellas, works by directly and selectively inhibiting activated Factor X in the cascade of blood coagulation.

16th February 2011

Share

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
mXm Medical Communications

mXm Medical Communications meets the needs of pharmaceutical marketers and medics who require a highly experienced, bespoke service from their...

Latest intelligence

patients
Retaining reader value in plain language summaries of clinical studies
Balancing the risk of misinterpretation with the public’s ability to understand simplified plain-language summaries...
Can we talk about the ego-bias and chemicals influencing your target audience’s behaviour?
Over the Summer, the Page & Page team became fascinated by two books on this very subject. Two books from one author, Dean Burnett, an eminent neuroscientist, lecturing at Cardiff...
Paris
Making Europe a leader in bioscience: boosting trust and opening minds
A vision of Paris as Europe's leading hub for life sciences innovation...

Infographics