WHO approves first generic, heat-stable version of Kaletra
Matrix Laboratories Limited, an India-based subsidiary of generic pharmaceutical manufacturer Mylan, Inc., recently became the first and only company to receive World Health Organization (WHO) approval to create lopinavir 250 mg/ritonavir 50 mg tablets. The combination of these drugs is marketed by Abbott Laboratories in the U.S. and Europe under the brand name Kaletra, and as Alluvia in the developing world.
Lopinavir/ritonavir is from the antiretroviral class of drugs known as protease inhibitors, and is used in combination with other anti-HIV medications to control HIV infection. Matrix’s version of the product is heat-stable and less costly than its brand name counterparts, making it more practical for distribution and use in warmer climates.
Approval from WHO indicates that a drug meets international safety, efficacy, and manufacturing quality standards, allowing for Matrix to market the product in most countries outside the United States and Europe. Matrix currently produces a wide range of generic antiretroviral products, including drugs that are recommended for first and second-line regimens. The company’s emphasis on producing affordable products has allowed it to drive down the average annual cost per patient of effective therapies. Approximately 30% of HIV/AIDS patients in the developing world depend on Matrix’s ARV products.
“Our goal is to provide HIV treatments to patients around the world—especially in developing countries,” said Mylan Vice Chairman and CEO Robert J. Coury. “With [our] heat-stable and affordable version of lopinavir/ritonavir, patients in remote parts of developing nations now have access to this important medicine.”