USA- The European Commission has approved Sunlenca® (lenacapavir) for use every six months along with other antiretrovirals to treat adults with HIV infections.
Lenacapavir is a first-in-class capsid inhibitor with a multi-stage mechanism of action and has no known cross-resistance to other existing drug classes.
The drug offers a new, every six-month treatment option for people with HIV whose virus no longer effectively responds to their current therapy.
“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.
He added that Lenacapavir is a unique and potent medicine with the potential for flexible dosing options and following the approval, it will now be the only twice-yearly treatment for people who struggle with multi-drug resistant HIV.
He highlighted that Gilead’s 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.
Sunlenca is expected to support Gilead’s multibillion-dollar HIV franchise in the long run if other medications like Descovy lose their patent protection
The clearance from the EU comes as Gilead tries to catch up to GSK’s ViiV Healthcare in the market for long-acting injectables, which are gaining popularity because they provide patients with greater convenience than daily oral pills.
Despite the enormous improvements in ARV medication, there are still many urgent and critical requirements for those living with HIV.
This is especially true for HIV patients who have undergone numerous treatments, have few therapeutic options, and are unable to sustain virologic suppression due to resistance or difficulties adhering to a demanding regimen.
This level of intricacy raises the likelihood of poor treatment adherence and failure, which emphasizes the need for a new treatment option that is effective against resistant viral variations and has a novel mechanism of action.
Sunlenca is expected to support Gilead’s multibillion-dollar HIV franchise in the long run if other medications like Descovy lose their patent protection. But there have been obstacles along the drug’s development and regulatory pathways.
Despite its effectiveness, Sunlenca needs to be used with other HIV medications. Therefore, if other ingredients in its combinations call for more frequent dosing, it doesn’t actually aid with convenience.
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