Dive Brief:
- The Food and Drug Administration has given Mylan N.V. a tentative nod for the approval of a fixed-dose formulation of dolutegravir, emtricitabine, and tenofovir alafenamide (TAF), under the U.S. President's Emergency Plan for AIDS Relief (PEPFAR).
- According to Mylan, this is the first combo tablet to include both dolutegravir and tenofovir alafenamide, and comes just under two years after the FDA's approval of Gilead's Descovy, which combines emtricitabine and TAF.
- The tablet, with doses of 50 mg, 200 mg and 25 mg respectively, will be the smallest single-tablet regimen available in the developing world, and will be as a 30- or 90-day package, potentially reducing trips to the clinic.
Dive Insight:
Mylan's new combination of dolutegravir, emtricitabine, and TAF, will be made available immediately in developing countries as a first-line regimen for people being treated with HIV/AIDS, following Tuesday's tentative approval by the Food and Drug Administration, under the U.S. President's Emergency Plan for AIDS Relief (PEPFAR).
According to Mylan, it provides anti-retrovirals to more than 40% of the people being treated worldwide for HIV/AIDS, and nearly half of the FDA's tentative approvals under PEPFAR are Mylan products.
"In the last year alone, we have been the first company to receive approval for three new fixed-dose combination products that use a lower dose of efavirenz, dolutegravir, and now dolutegravir in combination with tenofovir alafenamide," said Mylan President Rajiv Malik.
As the world's largest producer of HIV/AIDS drugs, Mylan says it "provides access to quality, dependable and affordable anti-retrovirals in more than 100 countries around the world."
"The FDA's tentative approval of Mylan's dolutegravir, emtricitabine, and tenofovir alafenamide tablets sets a new standard for affordable access for patients in countries hardest hit by HIV…" said Mylan CEO Heather Bresch. "With limited funding, the world needs cost competitive and clinically effective products like this one, and Mylan is proud to work with partners to make it."
However, "affordable" isn't necessarily the word many people would use to describe Mylan's drugs.
In 2007, Mylan acquired the EpiPen, an epinephrine autoinjector used by people at risk of severe and life-threatening allergic reactions. By 2016, the company had more than 85% of the epinephrine injector market, and had hiked the price up by more than 400%, rising to $608 for a twin pack. Mylan then created a generic version, still retailing at $300.
The pricing furor was then compounded when the company was accused of classifying the injector as a generic drug under the Medicaid Drug Rebate Program, which resulted in the Department of Health and Human Services (HHS) losing out on $1.3 billion worth of rebates between 2006 and 2016. Mylan eventually had to hand over $465 million as a settlement.