Janssen – a pharmaceutical arm of Johnson & Johnson – has announced that its new first-of-its-kind HIV drug, Cabenuva (rilpivirine and cabotegravir), has received approval for an expanded label from the US Food and Drug Administration (FDA) and can be given to eligible patients with HIV every two months.
The long-acting HIV treatment is part of a collaborative development between Janssen and Viiv Healthcare.
Cabenuva is made up of two separate injectable medicines – rilpivirine, Janssen’s single-dose vial injectable and Viiv Healthcare’s cabotegravir, which is also produced as a single-dose vial.
The new treatment is specifically for adults with HIV-1, who have no previous history of treatment failure and no recorded or suspected resistance to either drug.
James Merson, global therapeutic area head at Janssen Research & Development, commented: “An important goal for us in HIV is alleviating the need for daily medication, which can serve as a constant reminder for people living with the condition.”
In order to assess the patient’s tolerability of Cabenuva, it is recommended that oral doses of both rilpivirine and cabotegravir should be given for approximately one month. Following this, the approval from the FDA indicates that Cabnuva may be dosed monthly or every two months.
The FDA’s approval of long-acting rilpivirine and cabotegravir is based on the global ATLAS-2M phase 3b trial results. In these trials it was demonstrated that giving a dose every two months was as effective as results seen in patients receiving a dose once a month.
The European Commission, Health Canada and the Swiss Agency for Therapeutic Products have approved both the once-monthly and twice-monthly versions of rilpivirine and cabotegravir as an injectable treatment. It is planned that regulatory reviews will go ahead with additional submissions expected this year.
“The expanded label approval for Cabenuva – to be administered every two months – marks an important step forward in advancing the treatment landscape for people living with HIV,” said Candice Long, president, Infectious Diseases & Vaccines, Janssen Therapeutics, a Division of Janssen Products.
Long added: “With this milestone, adults living with HIV have a treatment option that further reduces the frequency of medication.”