FDA Approves Merck's Novel Two-Drug HIV Combination Therapy

Deep News03:20

The U.S. Food and Drug Administration has approved a new, once-daily, oral two-drug regimen, doravirine/islatravir, developed by Merck for the treatment of HIV-1 infection. The medication is indicated for adult patients who have achieved viral suppression following antiretroviral therapy.

The approval was primarily based on data from two pivotal Phase III clinical trials. Results demonstrated that after 48 weeks of treatment, the new regimen was non-inferior in efficacy to both the existing baseline antiretroviral therapy and three-drug regimens based on integrase inhibitors. Furthermore, the safety profile of the new regimen was comparable to that of the control groups.

The Head of Global Clinical Development at Merck stated that this regimen will provide an important new, complete treatment option for people living with HIV, helping to meet diverse patient health needs. It is noteworthy that Merck and Gilead Sciences are also evaluating another combination therapy, involving a Phase II study of islatravir in combination with lenacapavir for the treatment of HIV.

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Comments

We need your insight to fill this gap
Leave a comment