Mylan will soon be bringing its recently approved HIV medications Symfi Lo and Cimduo to market. The company on Friday said Symfi Lo would become available in the coming weeks, with Cimduo’s launch anticipated in the second quarter. Mylan said that the launches are aimed at reducing the cost of HIV treatments, which is more than $20 billion annually, according to IQVIA data.
“As the world’s largest supplier of antiretrovirals by volume, Mylan is deeply committed to expanding access to treatment for people living with HIV,” said Mylan CEO Heather Bresch. “For a decade, we have helped transform the level of access to high-quality, affordable HIV medications in developing countries. We are excited to bring that same passion to the U.S. with the upcoming launches of Symfi Lo and Cimduo and help deliver significant savings to the healthcare system.”
Symfi Lo (efavirenz, lamivudine 400 mg and tenofovir disoproxil fumarate 300 mg) is a once-daily single-tablet antiretroviral regimen indicated as a complete treatment for HIV-1 in adults and children weighing at least 35 kg. Cimduo (lamivudine 300 mg and tenofovir disoproxil fumarate 300 mg) is a once-daily combination of two nucleoside reverse transcriptase inhibitors that is indicated to be used in combination with other antiretroviral medications to treat HIV.
Mylan said that Symfi Lo’s efavirenz dose is one-third less than the dose originally approved in 1998, and the product was given tentative approval from the Food and Drug Administration in February under the U.S. President’s Emergency Plan for AIDS Relief program. The company dispensed the drug to more than 1 million patients worldwide last year, it said.
“Symfi Lo and Cimduo bring to the U.S. the innovations Mylan has pioneered in the delivery and dosage forms of ARVs used by millions of patients in high-burden countries around the world. We are proud of our continued investments in R&D and manufacturing for ARVs, and we are excited to extend the value of these to Americans living with HIV,” said Mylan President Rajiv Malik. “In particular, we believe the option to take a lower dose of efavirenz in a single-tablet regimen with Symfi Lo will be a welcome addition for patients and providers.”
The company said that it would discount Symfi Lo’s list price, and it would offer Cimduo as a significantly discounted list price compared with other similar treatments.
March 2, 2018