Merck & Co., Inc. (NYSE:MRK) has said that it plans to seek approval for its once-daily formulation of Isentress (raltegravir) in the U.S. and several other countries. That comes after the company presented safety and efficacy data on the investigational therapy for treatment of HIV-1 in adult patients.
The announcement of the plans to seek license approval for the drug in several more countries also comes after the European Medicines Agency agreed to review the results from the pivotal Phase 3 study of raltegravir. But besides the U.S., Merck didn’t name the other countries it hopes to apply for license for raltegravir, but it said that it hopes to begin the process of license approval before the end of this year.
Merck presented safety and efficacy data on raltegravir in South Africa during the 21st International AIDS conference. The data specifically came from the pivotal Phase 3 ONCEMRK study that covered 48 weeks. The drug was tested in patients with previously untreated HIV-1 infection.
The study outcome
First, the once-daily formulation of ISENTRESS (raltegravir) is known as raltegravir 600 mg. After 48 weeks of raltegravir 600 mg treatment, evaluation of the results showed that the once-daily formulation was statistically non-inferior to the approved dose of the twice-daily Isentress 400mg.
It is worth pointing out that each of the formulations was rendered as a combination therapy with Truvada.
The treatment difference observed in the study was 0.5, based on the assessment of the proportion of patients having less than 40 copies/mL of the HIV RNA.
Safety of the once-daily formulation
According to Merck’s data on safety of the once-daily raltegravir 600 mg, the formulation exhibited adverse events and discontinuation rates comparable to those of the approved twice-daily Isentress 400mg.
Additional therapeutic options
The once-daily raltegravir 600 mg is expected to expand the treatment options for patients with HIV once it is cleared for marketing. But Merck is not currently discussing what amount of revenue it hopes to generate from the sale of the therapy. Experts involved in the ONCEMRK study also say that the once-daily formulation will simplify HIV regimen for many patients.