Baxalta Inc (NYSE:BXLT) has announced that its drug, Adynovate, has received an approval from the Japanese ministry of health, labor and welfare, to be used in the treatment of hemophilia patients that are 12-years or older. The schedule for the drug has been kept at twice a week. Through this decision, BXLT would now be able to transfer marketing rights of the drug, from Baxter Limited to Baxalta Japan Limited.
The World Federation of Hemophilia has stated that the decision would extend access to the drug, for approximately 5,000 people. In the US, however, the drug enjoys the status of an on-demand treatment and control drug. It is administered to patients above 12, to reduce bleeding episodes and prophylaxis. Moreover, the company is now seeking FDA approval to administer the drug to patients below 12-years of age.
Baxlata has a supplemental Biologics License application, pending at the FDA in this regard. A similar application is pending in the EU, which would allow the drug to be used in a surgical setting and as well as during surgery. The drug was originally developed in collaboration with Nektar Therapeutics, using their PEGylation technology. The technology allows the drug to remain inside the system for longer periods, thereby increasing its half-life and efficiency.
Baxalta had submitted the data from a phase-3 trial of the drug, by conducting non-randomized study in patients. The population included patients from 12 to 65 years of age. The study also revealed that patients treated twice a week, with the drug, had a 95% reduction in the annualized bleed rate. The phase-3 results also identified nausea and headaches as the adverse effects of the drug. Moreover, a total of 40% of the population experienced zero bleeds, during the trial. However, it should be noted here that only 11 out a patient population of 120 were Japanese.
Baxalta Inc (NYSE:BXLT) lost 7.39% of its share value, during the April 5 trading session, to reach a close at $38.50.