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Merck's Two HIV Drugs Get FDA Approval for Expanded Use

Zacks Equity Research

Merck & Co., Inc. MRK gained FDA approval for its supplemental new drug applications (sNDAs) looking for label expansion of its two new HIV drugs — Pifeltro and Delstrigo.

Pifeltro and Delstrigo were approved by the FDA in August last year for the treatment of adults with no prior antiretroviral treatment experience. With the latest FDA nod, the HIV drugs are now approved for use in treatment-experienced adults living with HIV-1 who are virologically suppressed. The abovementioned HIV patients on a stable antiretroviral regimen now have the choice to switch to Pifeltro (in combination with other antiretrovirals) or Delstrigo.

Merck’s shares have risen 11.4% this year so far compared with the industry’s increase of 0.5%.

 

The sNDAs were based on data from the phase III DRIVE-SHIFT study. Data from the study, presented in the past, showed non-inferior efficacy in those patients who switched to Delstrigo compared to those who continued on their baseline regimen.

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 once-daily fixed-dose combination regimen containing doravirine, lamivudine and tenofovir disoproxil fumarate.  Both the drugs are not cures for HIV-1 infection or AIDS.

Although there are several drugs approved to manage HIV virus infection, there is no cure available in the market. Gilead Sciences GILD and GlaxoSmithKline GSK currently dominate the HIV-drug segment with several drug regimens in their portfolio. The drugs from these companies generate billions of dollars in revenues every quarter.

Merck currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Another top ranked large-cap pharma stock is Roche Holding AG RHHBY, carrying a Zacks Rank #2. Shares of Roche have gained 14.9% this year so far.

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