Merck & Co Inc has announced that the US Food and Drug Administration has approved two of its HIV oral drugs, nearly two months ahead of schedule. Reuters Health reports that Merck said 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.
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.
The report says that according to the World Health Organisation, more than 70m people have been infected with the HIV virus and about 35m have died since the beginning of the epidemic.
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.
The report says Gilead Sciences and GlaxoSmithKline have dominated the market for HIV/Aids treatments and sell therapies that generate billions of dollars.
[link url="https://www.reuters.com/article/us-merck-co-fda/fda-approves-two-new-hiv-drugs-from-merck-idUSKCN1LF2IL"]Reuters Health report[/link]