7 new medicines recommended by CHMP for approval in January 2015

By William Chin, PhD, Scientific Coordinator, EUCRAF

Seven new medicines have been recommended for approval at the January 2015 meeting of the Committee for Medicinal Products for Human Use (CHMP).

Medicine

Active ingredient

Applicant

Indication

Dutrebis

lamivudine / raltegravir

Merck Sharp & Dohme 

Treatment of human immunodeficiency virus (HIV-1)

Ikervis

ciclosporin

Santen 

Treatment of severe keratitis

Kengrexal

cangrelor

The Medicines Company UK 

Reduction of thrombotic cardiovascular events

Orbactiv

oritavancin

The Medicines Company UK

Treatment of acute bacterial skin and skin structure infections

Raplixa

human fibrinogen / human thrombin

ProFibrix 

Supportive treatment where standard surgical techniques are insufficient for improvement of haemostasis

Saxenda

liraglutide

Novo Nordisk

Treatment of obesity

Sivextro

tedizolid phosphate

Cubist

Treatment of acute bacterial skin and skin structure infections

Five medicines have received positive recommendations on new therapeutic indications: Abraxane (Celgene), Aloxi (Helsinn Birex Pharmaceuticals), Eylea (Bayer), Jakavi (Novartis) and Prevenar 13 (Novartis).

Source

1. EMA News, 23 January 2015, Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 January 2015.