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FDA approves first extended-release injectable HIV drug regimen

The FDA approved cabotegravir and rilpivirine, injectable formulation (Cabenuva), as a complete regimen for the treatment of HIV-1 infection. The injectable is intended for adults to replace a current antiretroviral regimen in those who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. It is the first approved injectable, complete regimen for adults with HIV-1 infection administered once a month, allowing some patients the option of taking once-monthly injections in lieu of a daily oral treatment regimen.


The FDA also approved cabotegravir in a tablet formulation (Vocabria), which should be taken in combination with oral rilpivirine (Edurant) for 1 month prior to starting treatment with Cabenuva to ensure the medications are well tolerated before switching to the extended-release injectable formulation.


The safety and efficacy of Cabenuva were shown in 2 randomized, open-label, controlled clinical trials in 1,182 adults with HIV-1 infection who were virologically suppressed before starting treatment with Cabenuva. Patients in both trials continued to show virologic suppression at the end of each study, and no clinically relevant change from baseline in CD4+ cell counts was observed.


Drug approved to reduce heart failure risk with reduced ejection fraction

Vericiguat (Verquvo) was approved by the FDA to reduce the risk of cardiovascular (CV) death and heart failure (HF) hospitalization following a hospitalization for HF or the need for outpatient I.V. diuretics in adults with symptomatic chronic HF and ejection fraction less than 45%.


Approval was based on results of the phase 3 VICTORIA trial in 5,050 adults with symptomatic chronic HF and left ventricular ejection fraction less than 45% following a worsening HF event. Verquvo was superior to placebo in reducing the risk of CV death or HF hospitalization at a median follow up of 11 months based on a time-to-event analysis. Treatment with Verquvo was associated with a 4.2% annualized absolute risk reduction compared with placebo; Verquvo also reduced the incidence of HF hospitalizations and CV death.

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Anemia and hypotension were the most common adverse reactions observed with Verquvo. Verquvo should not be used by patients with concomitant use of other soluble guanylate cyclase stimulators or by pregnant women.


Verquvo is a product of Merck.


New treatment approved for overactive bladder

The FDA approved vibegron (Gemtesa) for the treatment of overactive bladder (OAB) in adults with symptoms of urinary incontinence, urgency, and urinary frequency in adults. Gemtesa helps relax the detrusor bladder muscle, enabling the bladder to hold more urine, thereby reducing symptoms of OAB. The oral treatment is the first beta-3-adrenergic agonist available as a once-daily pill that does not require titration. Gemtesa is a product of Urovant Sciences.


Approval was based on the results of a phase 3 study in which patients were randomized to receive Gemtesa 75 mg once daily (545 patients), placebo (540 patients), or tolterodine extended-release 4 mg once daily (430 patients) for 12 weeks. Data showed that treatment with Gemtesa was associated with statistically significant reductions in daily urge urinary incontinence (P<.0001), micturition (P<.001), and urgency episodes (P=.002), and an increase in the volume voided (P<.0001) compared with placebo.

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The most common adverse reactions reported with Gemtesa included headache, urinary tract infection, nasopharyngitis, diarrhea, nausea, and upper respiratory tract infection. Gemtesa may cause urinary retention, especially if patients have bladder outlet obstruction or take other medications for OAB.