Matrix Laboratories Limited has received the first and only tentative approval from the US Food and Drug Administration under the President's Emergency Plan for AIDS Relief (PEPFAR) for its Abbreviated New Drug Application (ANDA) for lopinavir/ritonavir tablets 200 mg/50 mg. Matrix's version of this product is heat-stable and affordable making it practical for distribution and use in warm climates.
Matrix chairman Robert J Coury said, "Mylan and Martrix are committed to our growing and high quality antiretroviral franchise. Our goal is to provide HIV treatments to patients around the world - especially in developing countries. With Matrix's heat-stable and affordable version of lopinavir/ritonovir, patients in remote parts of developing nations with have access to this important life-saving drug. This is the second regulatory approval that this important product has recently earned, which further confirms our commitment to providing high-quality medicines at affordable prices."
Lopinavir/ritonovir tablets are the generic version of Abbott Laboratories' Kaletra tablets, the brand marketed in the US and Europe, and Aluvia tablets, the brand marketed in developing countries. It is used in combination with other medications to control HIV infection and is included in the antiretroviral (ARV) class of drugs known as HIV protease inhibitors.
Last month, Matrix was awarded the first and only World Health Organization (WHO) approval for the same product. These approvals indicate that Matrix's lopinavir/ritonovir tablets meet internationals safety, efficacy and manufacturing quality standards. This status will significantly increase access to affordable, high quality medicines in many countries, particularly priority countries with high AIDS prevalence rates.
Matrix's wide range of ARV products includes active pharmaceutical ingredients (API) and first and second-line finished doses. Patients often use second-line therapies if and when they develop resistance to initially prescribed treatments or experience clinical failures. 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 per cent of HIV/AIDS patients in developing countries depend on Matrix ARV products.