Janssen's mixed bag from CHMP meeting

Belgian Johnson & Johnson subsidiary Janssen-Cilag received a mixture of news from the late-November meeting of the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP).

On the one hand, the CHMP adopted positive opinions for both Stelara (ustekinumab) in the treatment of moderate-to-severe plaque psoriasis and Zevtera (ceftobriprole medocaril), co-developed with Basilea Pharmaceutica, as a therapy for complicated skin and soft tissue infections, as well as to extend the indication for HIV drug Prezista (darunavir) to include treatment-naive patients in addition to the current indication of heavily pre-treated people who failed more than one regimen containing a protease inhibitor, due to the new 400mg strength tablet of the drug.

Less positively, the CHMP has recommended that the marketing authorization for the firm's Ionsys (fentanyl HCl) be suspended due to a defect with the delivery system that the Committee says could lead to overdose.