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EMA Moves Forward with Recommendation for Lenacapavir based on 26-Week Data

A positive recommendation now heads to the European Commission, which can grant marketing authorization for 27 European Union member states.


The European Medicines Agency (EMA) adopted a appositive opinion for investigational lenacapavir to treat HIV in combination with other antiretroviral therapies, according to a press release from drugmaker Gilead. This opinion comes from the Committee for Medicinal Products for Human Use (CHMP) and is targeted to adults with drug-resistant HIV for whom it is otherwise not possible to achieve viral suppression.

The investigational, long-acting capsid inhibitor is being evaluated in multiple ongoing studies, the statement added, and is designed to be administered twice yearly. Additionally, the press release noted, the drugs different than most other ARTs because it is designed to inhibit HIV at multiple stages within the life cycle, having no known resistance to other existing drug classes.

The next step is for the CHMP recommendation to go to the European Commission to grant marketing authorization in the 27 member states of the European Union, the press release continued, with a decision expected later in 2022.

“Treatment options are extremely limited for people living with HIV whose virus is no longer effectively controlled by their current regimen,” Jared Baeten, MD, PhD, vice president, HIV Clinical Development, Gilead Sciences said in the statement. “We are encouraged by this CHMP positive opinion for lenacapavir, as it is an important step toward a potential new treatment option for individuals with multi-drug resistant HIV.”

In the United States, investigational lenacapavir studies were paused by the FDA in March as they were concerned about the compatibility of the drug with the borosilicate glass vials they were stored in, as Contagion previously reported.

Results from the phase 3 CAPELLA trial were presented at the 2021 Annual Conference on Retroviruses and Opportunistic Infections (CROI) in 2021 and then in May, published The New England Journal of Medicine. These results showed that participants with drug-resistant HIV had limited or no ARTs available to them and had experienced between 9 to 11 antiviral agents. By week 14, the principal investigator explained to Contagion, 81 percent of participants had undetectable HIV and sustained this metric through week 26 of the study.

Just under two-thirds of the participants experienced injection site reactions, though the principal investigator noted in another interview with Contagion that these reactions were all mild and no participant stopped treatment because of them.

The study remains ongoing and the investigators aim to publish the 52-week data in the future. The team also wants to explore investigational lenacapavir in treatment-naïve patients and for HIV PrEP implementations, they said.

The FDA’s clinical hold on investigational lenacapavir was lifted in May once Gilead provided new data to the FDA outlining their plan to store the drug in a vial made from aluminosilicate glass. When the pause went into effect, 10 clinical studies were put on hold but then were allowed to resume.

As Contagion has previously noted, Gilead has worked in HIV research, treatment, and prevention for 35 years with credits including 11 HIV medications and the first single-tablet antiviral regimen for HIV PrEP. They received Breakthrough Therapy Designation for lenacapavir after the results of the CAPELLA trial were released.