After stinging FDA setback, GlaxoSmithKline’s ViiV finally notches US approval for long-acting HIV injection

GlaxoSmithKline’s HIV unit ViiV was dealt a stinging loss back in late 2019 when the FDA slammed the brakes on its application for a once-monthly injection based on manufacturing issues. Now, with that roadblock in the rearview, ViiV has finally made good on its promise to change the HIV game.

The FDA on Thursday approved ViiV’s Cabenuva (cabotegravir and rilpivirine) as a long acting, once-monthly therapy for HIV-positive adults who are virologically suppressed and on a stable antiviral regimen.

Cabenuva is the first FDA-approved injectable for HIV on the market and will look to replace the daily oral pills that are currently standard of care in treating HIV-positive adults. The agency based its review on data from the Phase III ATLAS and FLAIR studies, which found Cabenuva helped maintain viral suppression after one year of treatment.

The agency also approved oral cabotegravir (Vocabria) in tandem with the dual injectable for virally suppressed HIV adults. The company plans to file that pill in the pre-exposure prophylaxis (PReP) setting and has a clutch of data backing its use over blockbuster Truvada from Gilead.

Sold as a two-shot kit, Cabenuva is recommended for treatment after patients have received oral cabotegravir and rilpivirine for at least a month to determine potential side effects, ViiV said in a release.

Cabenuva’s road to an approval took surprisingly long after the FDA hit the company with a CRL back in December 2019, citing manufacturing concerns. Kimberly Smith, ViiV’s head of R&D, said that delay was “obviously disappointing,” but was — in hindsight — a blessing as it allowed the drugmaker to add even more long-term safety data to its reworked application.

“It was a relief that the issue was around the manufacturing process and not around the safety of the product,” Smith told Endpoints News. “We worked very closely with our colleagues in CMC to make sure we clarified to the FDA to what the questions were and how we addressed them. It was particularly important for us to make sure that we nailed it.”

Cabenuva’s monthly injectable formulation will be a game-changer for the HIV population, ending the often laborious process of keeping up with a daily pill, Smith said. While injections will require patients to go to an HCP, Smith said her team had heard nothing but positive reviews about the dosing requirements.

“What we learned (from reaching out to doctors) was essentially that it wasn’t going to be as tough as they expected,” Smith said.

The drugmaker said some clinics have established special lines for patients to receive their injections during Covid-19 and others had created designated parking spaces for patients to get the shots without entering the building.

With the initial approval out of the way, ViiV plans to soon file an amended application for a once-every-two-months regimen for Cabenuva with the groundwork laid at the FDA, Smith said. That updated regimen would get patients closer to a “normal frequency of visits to an HCP,” she said.

Click to view original post