logo
Share SHARE
FONT-SIZE Plus   Neg

Celgene Int'l.: CHMP Adopts Positive Opinion For REVLIMID - Quick Facts

Celgene International Sàrl (CELG: Quote) said the European Medicines Agency's or EMA: Committee for Medicinal Products for Human Use or CHMP has adopted a positive opinion for REVLIMID to treat patients with transfusion-dependent anemia due to low or intermediate-1-risk myelodysplastic syndromes or MDS associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.

The CHMP, that reviews applications for all 27 member states in the European Union or EU, as well as Norway and Iceland, has recommended approval for REVLIMID in this indication. The European Commission, which generally follows the recommendation of the CHMP, is believed to make its final decision within two to three months.

MDS is a type of cancer where the production of blood cells and platelets by the bone marrow is disrupted, which can often lead to severe anemia, infections and bleeding.

The CHMP positive opinion was based on the results of MDS-004, a phase III, multi-center, randomized, double-blind, placebo-controlled trial. The largest trial of MDS del(5q) patients conducted to-date, MDS-004 compared the efficacy and safety of once-daily oral treatment with REVLIMID to placebo in 205 patients at 37 participating centers throughout Europe.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
Internet giant Google Inc. (GOOGL, GOOG) has launched a new online flight search tool that makes it easy to find out the best flight deal. The tool dubbed "Google Flights" provides a calendar that one can scroll through and see the lowest fare highlighted for each day. One can also use the lowest... Hyperloop Transportation Technologies, a start-up that has adopted Elon Musk's ambitious project of high-speed transportation system, plans to build a Hyperloop test track in California and completed as early as 2016. Hyperloop Test Technologies, a crowd-funded company, plans to take Musk's dream... Colors have set the social media afire after an otherwise innocuous photo of a bodycon dress kept users guessing as to what hues permeate it. Opinions are divided, with some seeing the dress as white and gold, and others as blue and black. The photo was posted on Tumblr by a user called Swiked.
comments powered by Disqus
Follow RTT