Merck's two anti-HIV drugs get FDA approval for increased use

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<p class = "canvas-atom canvas-text Mb (1.0em) Mb (0) – sm Mt (0.8em) – sm" type = "text" content = "Merck & amp; Co., Inc. MRK has obtained FDA approval for its additional new drug applications (sNDA) in search of an extension of the label of its two new anti-HIV drugs – Pifeltro and Delstrigo. "Data-reactid =" 11 ">Merck & Co., Inc. MRK has obtained FDA approval for its additional drug applications (sNDA) in search of an extension of the label of its two new anti-HIV drugs – Pifeltro and Delstrigo.

Pifeltro and Delstrigo were approved by the FDA last August for the treatment of adults without previous antiretroviral therapy experience. With the latest FDA approval, anti-HIV drugs are now approved for use in treatment-experienced adults living with HIV-1 and virologically oppressed. The above-mentioned HIV patients on stable antiretroviral therapy now have the choice to switch to Pifeltro (in combination with other antiretrovirals) or Delstrigo.

Merck shares have increased 11.4% this year so far, compared to a 0.5% increase in the industry.

The sNDAs were based on data from the Phase III DRIVE-SHIFT study. Data from the study, presented in the past, showed a not inferior efficacy in patients who switched to Delstrigo compared to those who continued their basic treatment.

While Pifeltro is a once-daily single tablet containing doravirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI), in combination with other antiretroviral agents, Delstrigo is a fixed-dose regimen containing doravirine, lamivudine and tenofovir disoproxil fumarate. Both drugs do not cure HIV-1 infection or AIDS.

Although several drugs have been approved to manage HIV infection, there is no cure in the market. Gilead Sciences GILD and GlaxoSmithKline GSK currently dominate the anti-HIV drug segment with several treatment schemes in their portfolio. The drugs from these companies generate billions of dollars in revenue each quarter.

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Roche Holding AG RHHBY is another leading large-cap pharmaceutical company. Roche's shares have gained 14.9% this year so far.

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