Europe's CHMP adopts positive opinions on Dexdor, Incivo, Plenadren, Vyndaqel and Zytiga; backs extensions

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), at its meetings last week, adopted positive opinions recommending the granting of marketing authorizations for the following new medicines:

• Dexdor (dexmedetomidine), from Finland’s Orion Corp, intended for sedation of adult intensive care unit (ICU) patients. Dexdor allows more flexibility in the ICU setting for patients who do not require deep sedation and has shown the additional advantage of reducing the time for extubation compared with the standard of care.

• Incivo (telaprevir; also known as Incivek), from Janssen-Cilag International, a unit of US drug major Johnson & Johnson (NYSE: JNJ) intended for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease. Telaprevir belongs to a new class of medicines for the treatment of chronic hepatitis that can directly inhibit viral replication in infected host cells which can lead to the eradication of the virus, and thus effectively to a cure of chronic hepatitis C. The CHMP assessed this application under an accelerated timetable, because it considered that, as 70% of hepatitis C virus infections in the Western world are genotype 1, there would be an important public health gain in making this medicine available to patients as a treatment option.