GSK’s Juluca gets European Medicines Agency approval for HIV therapy
Date: 2018-03-24   Author: Dhananjay Punekar  Category: #news

GSK’s Juluca gets European Medicines Agency approval for HIV therapy

European Medicines Agency, an EU authority that evaluates medicinal products, has approved GlaxoSmithKline’s two-drug treatment for HIV (human immunodeficiency virus), that causes AIDS (Acquired Immune Deficiency Syndrome). Reportedly, the board constituted for evaluating the human use of medicinal product supported the application of the two-drug regimen.

Juluca, a new HIV drug therapy, is a fixed dosage tablet combining two previously approved medicines, rilpivirine & dolutegravir, and is available for the patients on a stable drug treatment for nearly half of the year.

As per reliable reports, Juluca has been produced by GSK’s subsidiary ViiV Healthcare, which has a small stake owned by Shionogi and Pfizer. ViiV’s integrase inhibitor medicine dolutegravir is a part of GSK’s old triple-drug treatment that is used to control the spread of HIV in the human body.

Earlier, in the last quarter of 2017, U.S Food and Drug Administration (FDA) had approved the two-drug regimen of GSK. The CHMP (Committee for Medicinal Products for Human Use) approval is likely to facilitate Juluca’s approval by the European Commission, which is expected to come by the second quarter of this year. 

According to U.S. FDA, Juluca’s safety & efficiency in the adult HIV patients were assessed in two clinical tests in which 1,024 patients, whose HIV was suppressed due to the existing anti-HIV drug therapy, participated. Some of the patients were asked to either continue with the anti-HIV drug treatment or switch to Juluca’s two-drug therapy.

Reportedly, FDA derived the outcomes from the clinical trials on both the patients treated with GSK’s Juluca drug as well as the ones receiving anti-drug treatment. The regulator found that GSK’s two drug therapy had proved more effective in treating the HIV virus in the patients as compared to those who were treated with anti-HIV medicines.



About Author


Dhananjay Punekar

Dhananjay Punekar

Dhananjay currently works as a content writer at AlgosOnline. A post graduate in mathematics as well as business administration, he worked as a process executive in Infosys BPO Limited before switching his professional genre. Following his childhood passion, he opted fo...

Read More

More from Dhananjay


Post Recommendents

L Catterton purchases steakhouse restaurant chain Del Frisco’s
Author: Paroma Bhattacharya

The stakeholders of Del Frisco will receive $8 for each share, that is, an 18.9% premium to the last closing price.

Texas base...


Tata Power to raise minimum Rs 4,000 cr through renewables InvIT
Author: Pankaj Singh

The company would also aim to reduce the debt level by selling non-core assets

Tata Power, the largest private power company in India, is keen on raising funds t...


Yiwu collaborates with Alibaba to boost digital transformation efforts
Author: Pankaj Singh

Yiwu, one of the most favored destinations in China amongst overseas traders, is reportedly in talks to explore new trade channels in alliance with domestic e-commerce giant Alibaba, in order to speed up the digital tr...