The recent first global approval of elsulfavirine has been reviewed in detail in the First Global Approval report in Adis’ journal Drugs[1], based on the development milestones tracked in AdisInsight[2].

In June 2017, elsulfavirine (Elpida®), developed by Viriom, received its first global approval in Russia for the treatment of HIV-1 infection in combination with other antiretroviral medicines.[3] Elsulfavirine, dispensed as a once-daily oral capsule, is a new generation non-nucleoside reverse transcriptase inhibitor (NNRTI), prodrug of the active compound VM1500a that is also being developed by Viriom.[4]

According to a report from CNN earlier in 2017, the Russian Federal AIDS center had recorded more than 1 million people living with HIV during 2016.[5] This is the results of a 10% per annum increase over the last five years. The most common reason for the spread of the disease is said to be the result of shared needles in communities of people who inject drugs. [5] [6]

Elsulfavirine was approved by the Russian Ministry of Health based on the positive results from a phase III, 48-week study in 120 patients in Russia.[7]

The prescribing information describes the risk of significant adverse events at rates above 10% and well as those between 1 and 10% as low, and states that the events are most common in the first 4 weeks of therapy but generally resolve without the need for treatment withdrawal.[8]

For further information related to the first approval of elsulfavirine please visit Drugs[1],  or to learn more about the overall development of elsulfavirine across all indications visit AdisInsight[2].

Image credit: mipan / Fotolia

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