A Gilead Sciences HIV drug designed for twice-yearly dosing is now on the market officially recognized Used in Europe to provide new treatment options for patients whose virus no longer responds to currently available therapies.
The approval, announced by the European Commission on Monday, covers the drug lenacapavir being used in combination with other antiretroviral drugs in people with HIV. The drug, which patients start with an oral dose before a long-acting injection, will be marketed under the brand name Sunlenca.
While there is no cure for HIV/AIDS, antiretroviral therapy can control the virus and give the immune system a chance to recover. Antiviral drugs work by addressing part of the viral life cycle and preventing viral replication. While most antiviral drugs target one stage of the life cycle, Foster City, Calif.-based Gilead designed Sunlenca to block HIV at multiple stages. In addition, the company said its new HIV drug has no known cross-resistance with other classes of drugs currently available to treat HIV. This means it can be used in combination with other HIV medicines.
The European Commission’s decision was based on the results of a placebo-controlled Phase 2/3 study that enrolled 72 patients with HIV resistant to multiple therapies. The results showed that 83 percent of study participants who received the experimental Gilead drug and other therapies achieved an undetectable viral load at week 52, meeting the study’s primary goal. Gilead also reported that patients treated with the drug showed increased levels of CD4 cells, a type of immune cell counts used to measure the health of the immune system in HIV patients. The most common adverse reactions reported were nausea and injection site reactions.The results of this study are post May in the New England Journal of Medicine.
“Lenacapavir is a unique and potent drug with the potential for flexible dosing options,” Gilead Chairman and CEO Daniel O’Day said in a prepared statement. “After being approved today, it will now be the only biannual treatment for people with multidrug-resistant HIV.”
The European regulatory nod is a first for Sunlenca.The drug hits a snag at the FDA; in March, U.S. agency reject Gilead filed for the drug due to manufacturing issues. Regulators have questions about the compatibility of the drug with the glass used in the vials. Gilead resubmitted its application in June. A regulatory decision is now expected by Dec. 27. Gilead said it expects to submit additional regulatory filings and decisions later this year.
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