Lupin Receives FDA Approval for Anti-HIV-1 Tenofovir Alafenamide Tablet

The American Food and Drug Administration (U.S. FDA) has approved Lupin Limited’s (Lupin) abbreviated new drug application (ANDA) for Tenofovir Alafenamide Tablets, 25 mg, a substitute for Gilead Sciences, Inc.’s Vemlidy® Tablets, 25 mg. The Lupin factory in Nagpur, India, will produce this product. The yearly sales of 25 mg Tenofovir Alafenamide Tablets (RLDVemlidy®) in the United States were $531 million (IQVIA MAT December 2022).

Tenofovir Alafenamide is a prescription medication used to treat HIV-1 infection in adults and pediatric patients aged 12 years and older. It is a type of antiretroviral medication that works by inhibiting the activity of reverse transcriptase, an enzyme that HIV uses to replicate itself.

Tenofovir Alafenamide is a newer version of the previously used Tenofovir Disoproxil Fumarate (TDF) and is designed to have better efficacy, safety, and tolerability. Tenofovir Alafenamide has a higher plasma stability, which allows it to be taken at lower doses than TDF, resulting in reduced systemic exposure and lower potential for side effects such as kidney and bone toxicity. Tenofovir Alafenamide also achieves higher concentrations of the active drug in target cells such as CD4+ T cells, which may contribute to its effectiveness.

Tenofovir Alafenamide is typically taken orally once daily in combination with other antiretroviral medications as part of a complete treatment regimen for HIV-1 infection. It is important to follow the instructions of your healthcare provider and to take TAF as prescribed to ensure optimal treatment outcomes. As with any medication, Tenofovir Alafenamide can cause side effects, so it is important to discuss any concerns or questions with your healthcare provider.

More About Lupin

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

The Company enjoys a leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas. Lupin is the third-largest pharmaceutical company in the U.S. by prescriptions. The company invested 8.7% of its revenue in research and development in FY22.

Lupin has 15 manufacturing sites, 7 research centers, more than 20,000 professionals working globally, and has been consistently recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector.

More About HIV-1

HIV-1 is a type of virus that causes acquired immunodeficiency syndrome (AIDS), a condition that damages the immune system and makes people more susceptible to infections and certain types of cancer. HIV-1 primarily infects CD4+ T cells, which are a type of white blood cell that play an important role in fighting infections.

HIV-1 is transmitted through contact with infected bodily fluids, including blood, semen, vaginal fluids, and breast milk. Common modes of transmission include unprotected sexual intercourse, sharing of contaminated needles, and transmission from mother to child during pregnancy, childbirth, or breastfeeding.

HIV-1 infection progresses in stages, with early symptoms resembling those of the flu. As the virus replicates and the immune system becomes progressively more compromised, more severe symptoms and infections can occur, leading eventually to AIDS.

While there is no cure for HIV-1 infection, antiretroviral therapy (ART) can be very effective at controlling the virus and preventing progression to AIDS. ART involves taking a combination of medications that target different stages of the HIV-1 replication cycle, with the goal of suppressing the virus to undetectable levels in the blood. This can help preserve the immune system and greatly improve life expectancy and quality of life for people living with HIV-1. It is also important to practice safe sex and take other precautions to prevent the transmission of HIV-1 to others.

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