- Gilead’s long-acting HIV shot Sunlenca is now cleared for sale in Europe, marking the first marketing authorization for a treatment the California biotechnology company hopes can be used broadly as a standard therapy and preventive regimen.
- The decision by the European Commission, announced Monday, authorizes Sunlenca for patients whose current treatment regimen can no longer keep their infection at bay. Sunlenca, previously called lenacapavir, will be added to other antiviral drugs to boost patients’ immune response and reduce levels of virus in the body.
- Gilead is still waiting on a regulatory decision in the U.S., where it has been delayed by manufacturing issues. An approval by the Food and Drug Administration’s December deadline could put the drug on track to reach sales that RBC Capital Markets analysts estimate will climb as high as $4 billion a year.
While Gilead has spent years and billions of dollars trying to expand its cancer drug business, HIV remains its core business due to the success of new combination therapies and preventive pills.
Sunlenca has potential advantages over existing treatments. The drug is injected only once every six months following a loading period with an oral version of the treatment, which could make the regimen more tolerable and less costly than others currently available.
Sunlenca is also the first HIV drug that targets the protein shell, or “capsid,” of the virus. That approach keeps the virus from breaking apart, blocking its replication in multiple ways. Antivirals like protease inhibitors only target a single process.
Prior to the European Commission’s authorization Monday, a key drug review committee of the European Medicines Agency recommended approval in late June.
Regulators based their decision on a trial called CAPELLA, which found the shot, when added to an optimized antiviral regimen, rendered viral loads undetectable in 81% of patients with multi-drug resistant HIV after 26 weeks of treatment.
The drug-resistant indication is the first treatment setting Gilead is targeting. Phase 3 trials are underway in pre-exposure prophylaxis, as is a Phase 2 trial testing the drug in people who have never received HIV treatment before.
Those trials were put on hold in the U.S. due to manufacturing issues flagged by the FDA. The agency was concerned about the formation of glass particles from the interaction between Sunlenca and vials made with borosilicate, and in March rejected Gilead’s initial approval application.
Gilead switched to a different type of vial, which led the FDA to clear a trial restart and paved the way for the company to resubmit its application.
Gilead said in its second-quarter earnings report that the trials have now resumed and are enrolling patients.