Business Wire

ViiV Healthcare announces FDA approval of Cabenuva (cabotegravir, rilpivirine), the first and only complete long-acting regimen for HIV treatment

Cabenuva allows virologically suppressed adults living with HIV without prior treatment failure or resistance to cabotegravir or rilpivirine to maintain viral suppression with 12 dosing days per year ...
Monthly Prescribing Reference

Cabenuva Approved as First Long-Acting Injectable for HIV Treatment

The approval of Cabenuva was based on data from two phase 3 trials which included 1182 HIV-infected adults who were virologically suppressed (HIV-1 RNA less than 50 copies/mL) prior to initiation. The ...
Medscape

FDA Approves HIV Injectable Cabenuva Initiation Without Oral Lead-in

Initiating treatment may become easier for adults living with HIV. The US Food and Drug Administration has approved a label update that allows adults living with HIV to begin treatment with Cabenuva ...
Bay Area Reporter

FDA approves first injectable HIV regimen

The federal Food and Drug Administration has approved Cabenuva, the first complete long-acting injectable HIV regimen that does not require daily pills. It is approved for people with an undetectable ...
Metro Weekly

FDA approves HIV treatment replacing daily pills with monthly injections

The U.S. Food and Drug Administration has approved the first monthly, injectable treatment for HIV. Cabenuva, developed by ViiV Healthcare, replaces the traditional daily pill regimen with two ...
FiercePharma

GSK's ViiV, post-FDA rejection, scores Canadian nod for once-monthly HIV regimen Cabenuva

Despite high hopes for its game-changing monthly HIV regimen Cabenuva, GlaxoSmithKline's ViiV Healthcare went back to the drawing board after the FDA slammed the drug's manufacturing late last year.
Business Insider

Janssen Announces Submission of Supplemental New Drug Application to U.S. FDA by ViiV Healthcare for Expanded Use of CABENUVA (rilpivirine and cabotegravir) as an HIV Treatment ...

TITUSVILLE, N.J., Feb. 24, 2021 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that a supplemental New Drug Application (sNDA) has been submitted to the U.S.
Forbes

Why Did The FDA Deny Approval For A Monthly HIV Injection Treatment?

Last week, the FDA denied the approval of Cabenuva, the first of its kind monthly HIV injection treatment. Developers hoped that the monthly injection would replace daily pills, thus making life ...
Yahoo

GSK logs win as Health Canada approves its monthly HIV injection

A GSK logo is seen at the GSK research centre in Stevenage (Reuters) - GlaxoSmithKline's HIV treatments division has received approval for its long-acting HIV injection from Canada's healthcare ...
Nasdaq

ViiV Healthcare Announces First Global Regulatory Approval of CABENUVA; the First Complete, Long-acting, Regimen for the Treatment of HIV

Simultaneous approval of VOCABRIA (cabotegravir oral tablets), for short-term treatment in conjunction with CABENUVA (cabotegravir and rilpivirine extended-release injectable suspensions), also ...
Business Wire

ViiV Healthcare announces FDA approval of Cabenuva (cabotegravir, rilpivirine), the first and only complete long-acting regimen for HIV treatment

The most common adverse reactions (incidence ≥2%, all grades) with Cabenuva were injection site reactions, pyrexia, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and ...