- The Food and Drug Administration on Tuesday approved the first two-drug regimen for maintenance treatment of HIV-1, giving patients who are virologically suppressed a safer and less burdensome option than current regimens consisting of three or more drugs.
- Juluca, which combines GlaxoSmithKline plc's Tivicay and Johnson & Johnson's Edurant, will be available in U.S. pharmacies beginning Dec. 11. Approval of the drug represents a major boon for GSK and should help the British drugmaker better compete with rival Gilead Sciences Inc.
- Likely with an eye to that competition, GSK used a priority review voucher — for which it paid $130 million to acquire — to speed up the FDA's review of the drug.
For GSK, approval of Juluca (dolutegravir/rilpivirine) marks a clean sweep of the three near-term product opportunities the drugmaker has highlighted as key to future growth. Over the past three months, GSK has also won regulatory OKs for its lung drug Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) and shingles vaccine Shingrix.
In HIV, the British drugmaker has remained a top competitor thanks to its majority ownership of ViiV Healthcare, which developed both Juluca and its component Tivicay. (Pfizer Inc. and Shionogi Ltd. also own stakes in ViiV.)
Together with Juluca, the three drugs could help offset flagging sales from GSK's flagship Advair franchise, which faces looming generic competition.
Success with the three drugs is all the more important due to lackluster R&D productivity for the company as a whole — something that CEO Emma Walmsley hopes to fix with a major R&D shakeup announced this past summer.
As the first two-drug regimen for maintenance treatment of HIV-1, Juluca represents a new phase in GSK and ViiV's efforts in the space.
"This is the start of a new era in HIV treatment," said ViiV CEO Deborah Waterhouse in a Nov. 21 statement. Two-drug regimens like Juluca offer the possibility of reducing long-term exposure to multiple anti-retrovirals and condense patient pill burden into a single, once-daily tablet.
One limitation, however, is that Juluca must be taken together with a meal.
GSK is currently developing two other two-drug regimens, one aimed at previously untreated patients and another as a long-acting injectable.
While GSK focuses on two-drug regimens, rival Gilead is hustling a new three drug combination through the FDA —using a priority review voucher of its own to secure a Feb. 12 decision date.
The combo consists of a new integrase strand transfer inhibitor called bictegravir together with Gilead's already approved Descovy (emtricitabine/tenofovir alafenamide). Gilead hopes to win approval for both maintenance treatment and for patients who are treatment naive.
Uptake of Descovy, which was approved in spring 2016, has been strong — boosting Gilead's HIV portfolio just as its hepatitis C franchise sputters.