Early development of six pharma agents urged in Japan

The early development of six pharmaceutical products in Japan has been recommended to their relevant manufacturers by the Study Committee on Usage of Unapproved Drugs at the Japanese Ministry of Health, Labor and Welfare.

The six products are: Schering-Plough's Noxafil (posaconazole), a treatment for invasive fungal infection which was approved in the European Union on October 25, 2005; Bristol-Myers Squibb's Orencia (abatacept), for rheumatoid arthritis in patients with an inadequate response to tumor necrosis factor antagonists and disease-modifying antirheumatic drugs, which was cleared in the USA on December 28, 2005; Celgene's Revlimid (lenalidomide), for anemia caused by myelodysplastic syndromes, which was oked in the USA on December 28, 2005; Astellas Pharma's Vaprisol (conivaptan), a euvolemic hyponatremia therapy which was approved in the USA on December 29, 2005; Swedish Orphan International's Orfadin (niticinone), for hereditary tyrosinemia type I, which was cleared in the USA and the EU in 2002 and 2005, respectively; and Genzyme's Myozyme (alglucosidase alpha), a treatment for Pompe disease, which was passed in the EU and the USA on March 29 and April 28 (see page 23), respectively.

Among these, a study for early development of Orfadin and Myozyme has been requested by academic societies and a patient group. Since Orencia is entering into Phase II clinical trials, safety of the drug should be closely watched, the study committee recommended to the MHLW.