The U.S. Food and Drug Administration has approved Merck & Co.’s once-daily oral combination regimen for HIV treatment, the company said on Tuesday, offering patients a new option to manage the condition.
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The two-drug combination of doravirine and islatravir, marketed as Idvynso, has been approved as a replacement for existing antiretroviral therapy in certain adults living with HIV/AIDS.
While islatravir remains an investigational therapy, Merck & Co.’s doravirine is already approved and marketed in the U.S. under the brand name Pifeltro for HIV-1 treatment in combination with other antiretroviral drugs, as well as in a single-tablet regimen called Delstrigo.
HIV-1 is the most prevalent strain of the retrovirus responsible for HIV/AIDS.
According to National Institutes of Health data, around 40.8 million people are living with HIV worldwide, with approximately 1.3 million new infections reported each year.
“Idvynso expands therapeutic diversity beyond the currently available oral treatment options,” said Dr. Eliav Barr, senior vice president and chief medical officer, Merck Research Laboratories.
In two late-stage trials involving more than 1,000 patients, the combination therapy met its primary endpoint by significantly suppressing HIV-1 replication in adults already receiving other treatments.
Last year, Merck & Co.’s oral drug combination was shown to be non-inferior to Gilead Sciences’ flagship therapy Biktarvy, demonstrating similar levels of HIV-1 suppression compared with the current standard of care.
While the results mark an important development milestone for Merck, RBC Capital Markets analyst Trung Huynh expects the initial commercial impact to remain limited, with a key growth catalyst likely coming from potential approval in treatment-naïve patients.
Merck’s HIV story is best viewed as a “multi-year build rather than a near-term growth driver,” said Huynh.
Islatravir is being tested in multiple trials in combination with other antiretrovirals for potential daily and once-weekly treatments for HIV-1.
