US FDA approves drug duo pill for HIV

By Flora Southey contact

- Last updated on GMT


Related tags: Hiv

The US Food and Drug Administration has approved ViiV Healthcare’s two-drug treatment for HIV-1 maintenance, the first time the drugs have been combined into a single pill.

ViiV Healthcare, which is majority owned by GlaxoSmithKline, and has Pfizer and Shionogi Limited as shareholders, said the combination therapy aims to reduce drug intake.

Juluca “provides people living HIV who are virologically suppressed, the option to reduce the number of antiretrovirals they take, while maintaining the efficacy of a traditional three-drug regimen,” ​said chief scientific and medical officer John Pottage in a statement.

Each film-coated tablet, to be taken once-daily, combines 50mg of integrase strand transfer inhibitor (INSTI) dolutegravir made by ViiV Healthcare, and 25mg of non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine 25mg made by Janssen Therapeutics.

“A combination of these two drugs is a potent, well-tolerated regimen that contains only 75mg of active ingredient in total, making for an extremely small pill size when formulated,” ​spokesperson Patricia O’Connor told us.

“Juluca is the smallest-sized, single-pill combination regimen for the maintenance treatment of HIV,” ​she added.

The firm told us it makes the drug at a GSK manufacturing facility in Ware, UK, but did not disclose whether the approval would drive capacity expansion or create jobs.

“Specific details on capacity and recruitment is company confidential information,” ​O’Connor told us.

Marketing plans

Spokesperson Isabelle Scali told us the firm is targeting developing markets, where patient populations with virologically supressed HIV-1 patients are higher.

ViiV filed for marketing approval with the European Medicines Agency on May 23, 2017, and expects an update from the Agency later this year.

“A submission has also been made in Canada, Australia and Switzerland,” ​said O’Connor.

Related topics: Drug Delivery, Delivery formulations

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