FDA Gives Mylan’s New HIV Drug a Thumbs-Up

The U.S. Food and Drug Administration (FDA) approved Mylan NV’s Symfi (efavirnenz, lamivudine and tenofovir disoproxil fumarate) for adult and pediatric HIV-1 patients who weigh at least 40 kilograms.

This marks the third HIV approval for the company. The FDA recently approved Cimduo (Lamivudine and Tenofovir disoproxil fumarate) and Symvi Lo (efavirenz, lamivudine and tenofovir disoproxil fumarate). Symfi Lo launched earlier this month. The company expects Cimduo and Symfi to launch in the second quarter of this year.

“As the largest supplier of antiretrovirals by volume in the world, Mylan has a longstanding commitment to expanding affordable access to treatments for people living with HIV,” said Heather Bresch, Mylan’s chief executive officer, in a statement. “As we continue to grow our U.S. portfolio of ARV (antiretroviral) products, now including Symfi Lo, Symfi, and Cimduo, we are providing access to patients and empowering them to choose the lower-cost ARV treatment option that is right for them.”

Symfi and Symfi Lo use the same triple combination, but Symfi Lo has a lower dose of efavirenz. Symfi has a dosage similar to other efavirenz products on the market. Mylan argues that their products’ list price will be lower than similar drugs.

“Mylan has been on the forefront of bringing innovative delivery and dosage forms of ARVs to millions of patients in the developing world,” Rajiv Malik, Mylan’s president, said in a statement. “We’ve already extended outreach to people in the U.S. 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.”

Efavirenz 600-mg tablets are a generic form of Bristol-Myers Squibb’s Sustiva. Efavirenz launched on February 1, 2018, and is indicated in combination with other retroviral drugs to treat HIV-1 in adults and pediatric patients at least three months old and weighing at least 3.5 kilograms.

Double and triple-combination cocktails are the trend for HIV treatments. On February 7, 2018, the FDA approved Gilead Sciences' Biktarvy (victegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg, BIC/FTC/TAF), a once-daily single tablet combination to treat HIV-1. The combination is indicated as a complete regimen to treat HIV-1 in adults with no antiretroviral treatment history or to replace current antiretroviral regimen in patients who are virologically suppressed on a stable antiretroviral regimen for at least three months with no history of treatment failure.

There is some speculation that Gilead, a leader in HIV treatment whose HIV franchise brought in $14 billion in revenue last year, may be on track to find a cure for the disease. A two-drug combo, GS-9620 and GS-9722, appeared to eradicate the virus completely in laboratory animals. Most advanced HIV therapeutics, typically a cocktail of two or three different drugs, are able to knock back the virus and control the disease. But the virus hides in pockets in the immune system, and if the patient stops taking the drugs, or is immuno-compromised or stressed, the virus can make a resurgence.

Although that’s at least several years down the road, companies are increasingly developing combination therapies to control the disease, and companies such as Mylan are coming out with lower-cost generic combinations as well.

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