Gilead Sciences Inc. announced that the European Commission has given marketing authorization to the company’s long-acting HIV injection and tablets Sunlenca (lenacapavir), making it the drug’s first global approval.
The drug will be marketed as Sunlenca in the European Union (EU). The marketing authorization applies to all 27 member states of the EU along with Norway, Iceland and Liechtenstein.
The treatment is authorized in combination with other anti-retroviral(s) for adults with multi-drug resistant HIV infection for whom an effective anti-viral regimen cannot be designed.
Sunlenca is approved to be given as a tablet-injection combo where the tablets are given as an ‘oral loading’ prior to administration of the long-acting injection. The injection is administered subcutaneously and given six months apart, twice a year.
Long-acting injections offer patients a more convenient administration option compared to taking oral pills daily.
“Sunlenca offers a new treatment option for people with HIV whose virus no longer effectively responds to their current therapy,” said Gilead in a press release.
Gilead will be going head-to-head with GSK’s ViiV Healthcare in the area of long-acting injectables. GSK’s Cabenuva can be administered once every two months and is available as a full HIV regimen.
Lenacapavir is a first-in-class capsid inhibitor with a multi-stage mechanism of action. It has no known cross resistance to other HIV drug classes in the market.
“After more than three decades of driving advancements in HIV treatment and prevention, Gilead scientists have now delivered an innovative new option for long-acting care,” said Daniel O’Day, chairman and chief executive officer, Gilead Sciences. “Lenacapavir is a unique and potent medicine with the potential for flexible dosing options.”
“Our goal is to deliver multiple long-acting options in the future, in the belief that this will make a fundamental difference in the journey to end the HIV epidemic,” O’Day added.
Data from the Phase II/III CAPELLA study supported Sunlenca’s marketing authorization application (MAA). The study evaluated lenacapavir in combination with an optimized background regimen in individuals with multi-drug resistant HIV, a patient population with significant unmet medical need.
Results of the CAPELLA study showed that 83 percent of participants who received lenacapavir paired with an optimized background regimen achieved an undetectable viral load after one year of treatment.
Sunlenca’s road to regulatory approvals has included some setbacks, including a clinical hold from the US Food and Drug Administration (FDA) due to concerns that the glass particles of the medication’s vial could get into the drug solution. This led the FDA to issue a on the drug’s application earlier this year. Gilead resubmitted its application with a different vial type and the FDA has set a new target decision date of December 27, 2022.
Additionally, Sunlenca currently has to be administered with other HIV drugs, although Gilead is evaluating it as a single agent HIV pre-exposure prophylaxis (PrEP) option in a Phase III trial called (PURPOSE 2).
Nevertheless, Gilead’s latest HIV drug offering will help support the company’s billion-dollar HIV portfolio, particularly when its immensely successful HIV drugs Biktarvy and Descovy go off patent.
Gilead is submitting additional regulatory filings and anticipates decisions by regulatory authorities to continue throughout the year.