Johnson & Johnson (J&J) has submitted its new combination HIV medicine for approval in the EU.
The healthcare giant’s Janssen subsidiary filed the marketing authorisation for a fixed-dose table that combines darunavir – the active ingredient in J&J’s big-selling Prezista – with Gilead’s cobicistat.
The combination treatment is the result of an agreement made between Janssen and Gilead in 2011 for the development and commercialisation of a once-daily, single tablet treatment for people with HIV-1.
Under the terms of the agreement, Janssen holds the worldwide rights for the darunavir/cobicistat combo, while Gilead retains sole rights for cobicistat as a stand-alone product and for use in combination with other agents.
The protease inhibitor Prezista has been a strong performer for J&J in recent years, achieving revenues of more than $1.2bn for the first nine months of 2013.
But HIV treatment is moving more towards combination treatment with complementary drugs, due to their simpler dosing and related improved adherence.
Cobicistat has proved a popular option as a companion to other HIV treatments due to its function as a pharmacokinetic enhancer or boosting agent.
In addition to featuring as part of J&J’s combination drug, cobicistat is also a part of Gilead’s own four-drug combination Stribild, which is approved in both the US and Europe, and is being investigated alongside Bristol-Myers Squibb’s Reyataz (atazanavir sulfate).
Cobicistat has also been recommended as a monotherapy in Europe under the name Tybost, although US regulators failed to recommend the drug on its own due to “deficiencies in documentation and validation of certain quality testing procedures and methods”.
J&J said that if the combination product is approved, it will be marketed under a new brand name.
“This filing demonstrates our ongoing commitment to develop new HIV treatment options and fixed-dose treatment regimens for those living with the disease,” commented Johan van Hoof, head of infectious disease and vaccines at Janssen.