logo
Plus   Neg
Share
Email
Comment

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

Celgene International Sàrl (CELG) 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

Quick Facts

Editors Pick
Amazon.com Inc. (AMZN) said Thursday that it has chosen the 20 metropolitan areas to move to the next phase of the selection process for the company's second headquarters. The company plans to invest over $5 billion and grow the second headquarters to accommodate as many as 50,000 high-paying jobs. Morgan Stanley (MS) reported net income applicable to company of $686 million, or $0.29 per share for the fourth quarter ended December 31, 2017. The results for the current quarter included a net discrete tax provision of $990 million or a loss of $0.55 per share. Excluding net discrete tax items, net... Cannae Holdings, Inc. said Wednesday that its portfolio company, Ceridian HCM Holding Inc., has confidentially filed for an initial public offering. Ceridian HCM, a provider of human resources software and services, filed a draft registration statement on Form S-1 to the U.S. Securities and Exchange Commission relating to the proposed IPO of its common stock.
comments powered by Disqus
Follow RTT