Glaxo (GSK) Gets FDA Nod for Long-Acting HIV Regimen Cabenuva

GlaxoSmithKline plc’s GSK HIV subsidiary, ViiV Healthcare and Johnson & Johnson JNJ announced that the FDA has approved Cabenuva for treating adults with virally suppressed (HIV-1 RNA less than 50 copies per milliliter) HIV-1 infection. Please note that Cabenuva is a combination of ViiV Healthcare’s long-acting, injectable cabotegravir and J&J’s injectable rilpivirine.

The company stated that Cabenuva is the first and only complete long-acting regimen approved for treating HIV-1 infection in adults. The drug is approved for adults who are on a stable antiretroviral regimen and have no history of treatment failure, and no resistance to either cabotegravir or rilpivirine.

ViiV Healthcare will start distribution of Cabenuva in the United States next month. The drug was also approved for a similar indication in Europe and Canada last year.

Please note that the FDA also approved cabotegravir oral tablets with the tradename of Vocabria along with Cabenuva approval. Vocabria is approved in combination with J&J’s Edurant (oral rilpivirine) for short-term treatment of HIV-1 infection in adults who are virologically stable and suppressed.

Edurant is approved in combination with other antiretrovirals as oral therapy for the treatment of HIV-1 infection in treatment-naïve adult patients. Both Vocabria and Edurant are approved as once-daily oral dosage.

Approval to Cabenuva will significantly reduce administrations of antiretroviral regimens to HIV-1 patients from 365 to 12 a year. Moreover, Glaxo stated that the majority of patients preferred Cabenuva to previous daily oral therapy in clinical studies.

The approval for Cabenuva was based on data from two pivotal studies — ATLAS and FLAIR. Data from these studies demonstrated that treatment with Cabenuva maintained viral suppression compared to a daily oral three-drug regimen.

Shares of Glaxo have plunged 21% so far this year against the industry’s increase of 6.1%.

ViiV Healthcare is an HIV company, majorly owned by Glaxo and Pfizer PFE. Notably, ViiV Healthcare focuses on advancing HIV care by exploring new treatment paradigms (two-drug regimens), modalities (long-acting injectables) and mechanisms of actions (including maturation inhibitors and broadly neutralizing antibodies).

Last month, the company announced that the Committee for Medicinal Products for Human Use recommended approval of Rukobia for heavily treatment-experienced adult patients with HIV-1 infection in Europe.

We remind investors that HIV is a key therapeutic area for Glaxo. However, rising competitive pressure coupled with shift within its portfolio toward two-drug regimens is hurting sales of Glaxo’s HIV business. HIV sales totaled £3.6 billion in the first nine months of 2020, reflecting an increase of only 1% year over year. Upon potential approval, new medicines should further boost sales of the HIV franchise.

Other key players in the HIV market are Gilead Sciences GILD, Merck and AbbVie.

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Zacks Rank

Glaxo currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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