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GlaxoSmithKline's ViiV Healthcare Bags EU Marketing Authorization For Long-Acting HIV Treatment

GlaxoSmithKline's ViiV Healthcare Bags EU Marketing Authorization For Long-Acting HIV Treatment

British pharmaceutical company GlaxoSmithKline PLC’s (NYSE: GSK) majority-owned subsidiary ViiV Healthcare received the marketing authorization approval for its HIV treatment in the European Union, the company announced on Monday.

What Happened: ViiV announced that the European Commission authorized Vocabria (cabotegravir injection and tablets) to be used in combination with Johnson & Johnson’s (NYSE: JNJ) subsidiary Janssen Pharmaceutical’s Rekambys (rilpivirine injection) and Edurant (rilpivirine tablets) to treat virologically suppressed adults with an HIV infection.

Adults in Europe diagnosed with HIV can switch over from the daily oral tablet regimen to an injectable and longer-acting alternative.

CEO of ViiV Healthcare, Deborah Waterhouse, says that 90% of the clinical trial participants claimed they would opt for the new regimen instead of the previous daily oral medication.

To receive the marketing authorization, ViiV conducted Phase 3 ATLAS (Antiretroviral Therapy as Long-Acting Suppression), FLAIR (First Long-Acting Injectable Regimen), and ATLAS-2M trials covering 1,200 participants across 16 countries.

Why It Matters: The patient-reported outcomes study (Positive Perspectives Wave 2) conducted by ViiV Healthcare showed that 55% of the participants preferred a longer-acting treatment to daily doses, whereas 38% of the participants were anxious that the daily doses could signal others about their medical condition.

The press release quoted Dr. Antonio Antela from the University Hospital in Spain saying that, “cabotegravir and rilpivirine injections could reduce the number of days of treatment per year from 365 down to 12 for the once-monthly, or 6 for the once every 2-months dosing regimen, representing a paradigm shift in how we are able to treat and manage the condition.”

The cabotegravir and rilpivirine treatment regimen, under the brand name Cabenuva, is approved for a dose once a month by the Canadian health authorities. In July, ViiV Healthcare resubmitted the New Drug Application (NDA) for once-monthly dosing of cabotegravir and rilpivirine, to the U.S. Food and Drug Administration, which is currently under review.

Price Action: GSK shares are down 2.73% at $36 in the pre-market session on the last check Monday. JNJ shares closed 0.58% higher at $154.51 on Friday.


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