The ID Pipeline: FDA Activity from the Week of April 7, 2019

Here is a look at infectious disease related US Food and Drug Administration news from the week of April 7, 2019.

Here is a look at infectious disease related US Food and Drug Administration (FDA) news from the week of April 7, 2019.

Janssen Announces 48-Week Data From Phase 3 Trial of Symtuza, a Rapid-Initiation Single-Tablet HIV Regimen

On Thursday, April 11, 2019, Janssen announced new 48-week data from the DIAMOND study, the first prospective phase 3 trial on the rapid initiation of Symtuza (darunavir 800 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg D/C/F/TAF), a single-tablet regimen for patients with HIV. According to the data, Symtuza was found to effectively help a high proportion of HIV patients achieve an undetectable viral load through 48 weeks after rapidly starting the medication, and 97% of patients reported being satisfied with the single-tablet regimen.

Symtuza is approved by the US Food and Drug Administration for the treatment of HIV-1 infection in treatment-naïve and certain virologically suppressed adults, and is now being studied as a rapid-initation regimen. Patients in the DIAMOND study were enrolled within 14 days of receiving an HIV diagnosis and then started on Symtuza before laboratory or baseline resistance test results were available.

Results from the DIAMOND study were presented at the 13th Annual American Conference for the Treatment of HIV (ACTHIV 2019) in Miami, Florida.

The full press release is available here.

FDA Approves Dolutegravir/Lamivudine for Treatment-Naive Patients With HIV

On April 8, 2019, the US Food and Drug Administration (FDA) issued an approval for dolutegravir and lamivudine (Dovato), as a complete regimen for treatment-naïve adults with HIV-1.

This marks the first FDA-approved 2-drug, fixed-dose, complete regimen for treatment-naïve adults with HIV, according to the press release.

"Currently, the standard of care for patients who have never been treated is a three-drug regimen. With this approval, patients who have never been treated have the option of taking a two-drug regimen in a single tablet while eliminating additional toxicity and potential drug interactions from a third drug," Debra Birnkrant, MD, director of the Division of Antiviral Products, said in the statement. "Having a drug-sparing treatment available that uses fewer drugs is beneficial to patients who may have issues taking multiple medications over a long period of time."

The full story is available here.