IHS Global Insight Perspective | |
Significance | Roche's Japanese subsidiary Chugai has confirmed the results of a study, which links Actemra to the deaths of 15 patients and severe side effects of over 200. However, the company is not going to stop selling the drug. |
Implications | Approved in Japan last April for RA treatment, Actemra, the first antibody drug originating from Japan, was forecast to be a blockbuster in its peak year. |
Outlook | The link to deaths and serious side effects is likely to give Actemra's sales a blow as well as trigger safety concerns in its U.S. regulatory approval review. |
Japanese drug maker Chugai, a unit of Swiss drug giant Roche, today confirmed that a study of about 5,000 cases has shown that its RA treatment Actemra (tocilizumab) might be a determining factor in the deaths of 15 Japanese patients and serious side effects found in 221 cases. The heavy side effects included severe fever, pneumonia and phlegmon. A spokesperson for Chugai noted that the company will not halt the sales of Actemra, however, it will provide more information to doctors about possible side effects of using the drug.
Setback for a Potential Blockbuster
As the first antibody drug originating from Japan, Actemra has been sold in Japan since 2005 starting as a treatment of Castleman's disease. In April 2008, Japan's Ministry of Health, Labour and Welfare gave its nod for the additional indication of RA treatment to Actemra (see Japan: 16 April 2008: Actemra, Humira Approved to Treat Rheumatoid Arthritis in Japan).
Looking outside the Japanese market, the European green light for the drug, marketed under the brand name RoActemra, came in January 2009; however, the U.S. FDA's okay has been delayed until the third quarter of 2009 (see Switzerland: 21 January 2009: Roche Clinches European Approval for Rheumatoid Arthritis Drug RoACTEMRA). The annual sales of Actemra in 2008 stood at ¥7.2 billion (US$73 million). According to Chugai's prediction, Actemra's peak-year global sales will reach over US$1 billion (see Japan: 18 February 2008: Access to Rheumatoid Arthritis Biologics to Improve in Japan).
Outlook and Implications
The first setback for Actemra's blockbuster hope came in September 2008, when the U.S. FDA asked for additional information on the drug's manufacturing process and detailing information. Although there were no concerns related to the drug's safety or clinical studies, the further request inevitably delayed Actemra's commercialisation in the world's largest pharmaceutical market.
Despite the continuation of the drug's sales, the serious side effects, especially with reported links to deaths, are likely to have a negative impact on Actemra's sales in both Japan and Europe. Moreover, it may also spark safety concerns in its pursuit of U.S. regulatory approval, which might lead to a longer review process or further safety watch and warning requests.
Nevertheless, as a new treatment option innovatively inhibiting the interleukin-6 receptor, Actemra still holds a significant market potential for RA treatment in competition with other drugs including Roche's own RA therapy MabThera/Rituxan (rituximab).