August 30, 2018 / 8:27 PM / 2 months ago

FDA approves two new HIV drugs from Merck

(Reuters) - Merck & Co Inc said on Thursday the U.S. Food And Drug Administration approved two of its HIV oral drugs, nearly two months ahead of schedule.

FILE PHOTO: A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. REUTERS/Jason Reed/File Photo

The drugs have been approved to treat adults with the most common strain of the virus, HIV-1, and target patients who have received no prior antiretroviral treatment, Merck said.

Delstrigo, a once-a-day combination tablet, has been approved with a boxed warning, the agency’s strictest, to flag risk of worsening hepatitis B infection.

Pifeltro, the second drug, is an oral medicine to be administered in combination with other antiretrovirals, Merck said.

Merck said it expects to stock both the treatments through wholesalers within a month.

More than 70 million people have been infected with the HIV virus and about 35 million have died since the beginning of the epidemic, according to the World Health Organization.

There is no vaccine to prevent HIV/AIDS with current treatments only helping patients to manage the disease. However, the fast-mutating virus has proved a challenge to the medical community as it often develops resistance to existing medicines.

Gilead Sciences and GlaxoSmithKline have dominated the market for HIV/AIDS treatments and sell therapies that generate billions of dollars.

Reporting by Tamara Mathias in Bengaluru; Editing by Sriraj Kalluvila

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