EU Approval Recommendations for Novartis and Roche Products

Europe's Committee for Medicinal Products for Human Use has released a positive statement on two products developed by Swiss drugmakers Novartis and Roche. The former company's Aclasta (zoledronic acid 5mg solution) injected treatment for Paget's disease in bones reportedly has a clear therapeutic advantage in relation to rival products. The company added that the therapy is also being studied as a potential treatment for osteoporosis, and final EU approval is expected later in the year.

Meanwhile, the CHMP also issued a favourable opinion on Roche's hepatitis B treatment Pegasys (peginterferon alpha-2a), which the company claims is more effective than the standard therapy, UK drug major GlaxoSmithKline's Zeffix (lamivudine). Roche claims Glaxo's product does not simultaneously stimulate immune system responses while slowing virus replication. The product is already widely approved as a treatment for Hepatitis C. However, despite the company's claims that worldwide sales of Pegasys are on course to reach the forecast US$1.7bn, revenue on the product in Japan, where it is distributed by local affiliate Chugai, recently failed to meet targets.