The FDA has approved a dual therapy for HIV from GlaxoSmithKline’s ViiV joint venture with Johnson & Johnson, which is expected to mount a strong challenge to rival treatments from Gilead.
The US regulator gave a green light to Juluca, which combines ViiV’s integrase inhibitor Tivicay (dolutegravir) with a non-nucleoside reverse transcriptase inhibitor Edurant (rilpivirine) developed by J&J’s Janssen unit, both of which are already approved for marketing separately.
The new regimen is “the first, complete, single-pill, two-drug regimen for the treatment of HIV”, rather than the standard three or more drugs, according to Janssen and GSK, and has been approved as a new option for people with HIV who have been virally suppressed on their current regimen for at least six months.
Patients considering Juluca as a treatment option should also have no history of HIV treatment failure and no known viral mutations associated with resistance to either of the drugs in the regimen, according to the FDA.
GSK has high hopes for the new regimen, so much so that it used an FDA priority review voucher purchased for $130m so it can bring the new product to market quickly. It has been trying to develop two-drug regimens that can reduce drug exposure and side effects, as well as improve adherence to therapy while maintaining the same level of efficacy.
Commenting on the approval, the head of the FDA’s antiviral products division, Debra Birnkrant, said: “Limiting the number of drugs in any HIV treatment regimen can help reduce toxicity for patients.”
The new drug is due to go on sale in December, crucially giving ViiV a few months grace before Gilead is due to get approval for a new three-drug regimen that adds integrase inhibitor bictegravir to the two ingredients in its fast-growing Descovy (emtricitabine/tenofovir alafenamide) product. Descovy was approved in the US last year and is often prescribed alongside Tivicay.
Figures from EvaluatePharma predict Gilead’s triple will make an impressive $4.4bn in sales in 2024, but it expects GSK to do a billion dollars better in that year with turnover of $5.4bn for Juluca. It’s an important drug for GSK, and along with shingles vaccine Shingrix and recently-approved triple therapy for chronic obstructive pulmonary disorder (COPD) Trelegy.
The company is also testing the combination of dolutegravir and Epivir (lamivudine) in phase III trials for treatment-naive HIV patients, and the pairing of integrase inhibitor cabotegravir and rilpivirine that could be given as a monthly or bi-monthly injection as an alternative to daily doses of tablets.
ViiV has said Juluca will be priced at about $31,000-a-year, comparable to its three-drug HIV regimen Triumeq (abacavir, lamivudine and dolutegravir), a $1.7bn product that is likely to be hit hard if Gilead’s triple regimen reaches the market.