EU medicines agency backs new drugs from J&J, others

LONDON, July 22 (Reuters) - European Medicines Agency statement following monthly meeting of Committee for Medicinal Products for Human Use (CHMP).

Positive opinions recommending the granting of a marketing authorisation, for the following medicines:

* Dexdor (dexmedetomidine), from Orion Corporation, intended for sedation of adult intensive care unit (ICU) patients.

* Incivo (telaprevir), from Janssen-Cilag International N.V., intended for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease.

* Plenadren (hydrocortisone), an orphan medicine from DuoCort Pharma AB, intended for the treatment of adrenal insufficiency in adults.

* Vyndaqel (tafamidis), from Pfizer Specialty UK Ltd, an orphan medicine intended for the treatment of transthyretin amyloidosis in adult patients with symptomatic polyneuropathy, a severe, progressive orphan disease.

* Zytiga (abiraterone acetate), from Janssen-Cilag International N.V., intended in combination with prednisone or prednisolone for the treatment of metastatic castration resistant prostate cancer in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.

Positive opinions for applications for extension of indication:

* Afinitor (everolimus), from Novartis Europharm Ltd, to include treatment of patients with unresectable or metastatic, well- or moderately differentiated neuroendocrine tumours of pancreatic origin in adults with progressive disease.

* Enbrel (etanercept), from Wyeth Europa Ltd, to extend the lower age range in polyarticular juvenile idiopathic arthritis (JIA) from four to two years; and to extend the lower age range in paediatric plaque psoriasis from eight to six years.

* Tarceva (erlotinib), from Roche Registration Ltd, to include first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer with EGFR activating mutations. (Reporting by Ben Hirschler)