FDA gives a ‘go-ahead’ for Made-in-China HIV drug Trogarzo
Date: 2018-03-08   Author: Dhananjay Punekar  Category: #news

The U.S. Food and Drug Administration has apparently given a green signal for the use of Trogarzo, a drug used in alternative HIV therapy for adult patients. Also referred to as Ibalizumab-uiyk, this drug has been developed by a Taiwanese firm TaiMed Biologics and manufactured in China in association with WuXi Biologics.

Reliable sources claim that Trogarzo is the first of its kind across the new class of antiretroviral medicines that can provide relief to the patients treated earlier with conventional drugs without any success. According to the U.S. drug authority, the new medicine was proved to be safe & effective in the clinical tests conducted by TaiMed on forty patients, who had experienced substantial improvement in a week after being treated with Trogarzo.

TaiMed stated that after 24 weeks of treating patients with both Trogarzo and other antiretroviral medicines, it was found that 43% of the patients had developed HIV RNA suppression. FDA declared that this medicine will be prescribed for a small percentage of patients (only around one percent), who have been treated for HIV infections through multidrug methodologies, but without any positive outcomes.

Jeff Murray, deputy director of the Antiviral Products division in the FDA’s Center for drug evaluation & research, remarked that while most of the HIV infected persons can be successfully treated by combining two or many antiretroviral medicines, a minor section of patients are resistant to multidrug therapy. He further added that these individuals will have limited treatment alternatives, thereby putting them at a higher risk of acquiring HIV-related complications.

Reports claim that TaiMed’s drug application received a fast-track approval, priority review, and breakthrough treatment designation from the FDA. Trogarzo was also granted the “orphan drug” status from the U.S. drug authority for promoting the discovery of new medicines with limited market potential.

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

Alibaba prioritizes SEA expansion, pours in USD 2bn more in Lazada
Author: Dhananjay Punekar

Alibaba Group Holding Limited, a Chinese eCommerce & retail firm, is expected to provide an additional investment worth USD 2 billion to Lazada Group SA, an eCommerce firm headquartered in Singapore.  Incident...

Grofers secures USD 61.6 million in funding round led by SoftBank
Author: Dhananjay Punekar

Grofers, an India-based online grocery delivery service, has received funds worth USD 61.6 million from SoftBank Group via its initial fund-raising round. Incidentally, the round also witnessed the participation of Apo...

Mayne Pharma Group launches a generic alternative to Monodox in U.S.
Author: Sunil Hebbalkar

Mayne Pharma Group, the Australia-headquartered drug delivery conglomerate, has recently announced the launch of doxycycline monohydrate IR capsules in the United States. Reportedly, the scarcely launched drug is a gen...