logo
Share SHARE
FONT-SIZE Plus   Neg

Merck: CHMP Adopts Positive Opinion For Isentress 600 Mg In EU

Merck & Co. Inc. (MRK) said that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency has adopted a positive opinion recommending approval of Isentress, or raltegravir 600 mg film-coated tablets, in combination with other anti-retroviral medicinal products, for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg.

In adults and pediatric patients, the recommended dosage is 1,200 mg (two 600 mg tablets) once daily for treatment-naïve patients or patients who are virologically suppressed on an initial regimen of Isentress 400 mg twice daily.

The CHMP positive opinion was based on findings from the ONCEMRK trial, an ongoing Phase 3 multicenter, double-blind, randomized, active comparator-controlled clinical trial.

The recommendation will now be reviewed by the European Commission for marketing authorization in the European Union. A decision on approval is expected in the second half of 2017.

The once daily formulation of Isentress is currently under review in the U.S. by the Food and Drug Administration.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Embark Veterinary Inc., a startup that makes dog DNA-testing kits for pet owners, vets and breeders, said it has raised $4.5 million in funding from investors and relocated its headquarters to Boston. The company intends to use the new funding to expand its canine genetic testing suite for pet owners, breeders, and veterinarians. Intel Corp. has completely shut down its wearables division about two weeks ago, CNBC reported, citing a person familiar with the matter. The company reportedly intends to focus on augmented reality. According to the CNBC report, Intel laid off about 80 percent of the team that made the Basis fitness watch in November 2016 and has now eliminated the division entirely. The Federal Trade Commission is investigating allegations that Amazon.com Inc. misled consumers about its pricing discounts, Reuters reported, citing a source close to the probe. The FTC probe is reportedly part of the agency's review of Amazon's proposed $13.4 billion deal to buy grocery chain Whole Foods Market Inc.
comments powered by Disqus
Follow RTT