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Symfi Triple Combo Once-Daily HIV Treatment Receives FDA Approval

MAR 28, 2018 | KRISTI ROSA
Another HIV drug combination developed by Mylan Pharmaceuticals has been approved by the US Food and Drug Administration (FDA).

The antiretroviral in question?

Symfi, a once-daily single-tablet regimen, which is comprised of efavirenz, lamivudine, and tenofovir disoproxil fumarate, in the form of 600 mg/300 mg/300 mg tablets. Symfi has been indicated as a complete treatment regimen for the treatment of HIV-1 infection in both adult and pediatric patients who weigh at least 40 kg, according to the announcement.

This comes on the heels of 2 other recently approved antiretrovirals (ARVs) developed by Mylan: Cimduo and Symfi Lo. Cimduo, comprised of lamivudine and tenofovir disoproxil fumarate, is a combination of nucleo(t)side reverse transcriptase inhibitors to be taken once-daily in the form of 300 mg/300 mg tablets; the drug is indicated to be used in combination with other ARV agents to treat adults and pediatric patients who have HIV-1 and weigh at least 35 kg. Symfi Lo tablets are another combination product comprised of efavirenz 400 mg, lamivudine 300 mg, and tenofovir disoproxil fumarate 300 mg. The recommended dose is 1 tablet, taken once-daily, on an empty stomach right before bed.

Mylan launched Symfi Lo in early March and expects to launch Cimduo and Symfi in the second quarter of 2018.

“Mylan has been on the forefront of bringing innovative delivery and dosage forms of ARVs to millions of patients in the developing world,” Rajiv Malek, president of Mylan, stressed in a recent statement. “We’ve already extended our reach to people in the United States living with HIV with the introduction of Symfi Lo and Cimduo. Adding Symfi to our portfolio further strengthens our commitment to investing in developing and manufacturing these important products.”

Although the drugs Symfi and Symfi Lo are comprised of the same triple combination of molecules, the difference between the 2 is in the dosing. While Symfi Lo includes a reduced dose of efavirenz, the newly-approved Symfi features dosing similar to other products containing efavirenz that are already on the market.

“The combination represented by Symfi 600 mg/300 mg/300 mg tablets is the most widely-taken ARV regimen outside of the United States, with more than 7 million users worldwide in 2016,” according to Mylan Pharmaceuticals.

Total spending on HIV drugs has increased 3-fold since 2007, outpacing the estimated growth in overall drug spending by a staggering 60%. In an effort to make HIV treatment more affordable in the United States, Mylan’s ARVs will be “discounted significantly” compared with similar medicines available on the market.
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