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Merck (MRK) Receives FDA Approval for Two HIV Medicines

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Merck & Co., Inc. (MRK - Free Report) announced that the FDA has approved two new medicines for the deadly HIV-1 disease containing its investigational medicine, doravirine. Delstrigo and Pifeltro were approved to treat adult patients who have not undergone any antiretroviral treatment.

Delstrigo is a once-daily triple combination regimen consisting of its non-nucleoside reverse transcriptase inhibitor (“NNRTI”), doravirine (100 mg), lamivudine (3TC, 300 mg) and tenofovir disoproxil fumarate (TDF, 300 mg). Pifeltro (doravirine), a once-daily single tablet should be administered in combination with other antiretroviral medicines. The FDA’s decision came almost two months ahead of the action date in late October.

However, Delstrigo was approved with boxed warning about post-treatment acute exacerbation of hepatitis B infection. Both the drugs are not cures for HIV-1 infection or AIDS.

Merck’s shares have increased 21.8% so far this year compared to the industry’s rise of 5.4%.


The approval to the drugs was based on encouraging data from two pivotal studies – DRIVE-AHEAD and DRIVE-FORWARD – evaluating Delstrigo and Pifeltro, respectively.

Data announced in 2017 from DRIVE-AHEAD study showed that Delstrigo met primary endpoint of non-inferiority to efavirenz/emtricitabine/tenofovir disoproxil fumarate combination. In the Destirogo arm, 84% of the patients achieved viral suppression of HIV-1 RNA below 50 copies/mL compared to 81% of patients in the comparator arm over 48-weeks of treatment. Delstrigo also achieved superiority in reduction to LDL-cholesterol and non-HDL-cholesterol from baseline level.

The DRIVE-FORWARD study compared Pifeltro to Pifeltro-ritonavir combination, which was administered along with emtricitabine, TDF, abacavir or 3TC. The Pifeltro arm achieved sustained viral suppression of HIV-1 RNA below 50 copies/mL in 84% patients through 48 weeks compared to 80% for the Pifeltro-ritonavir combination arm. Pifeltro also achieved statistically significant superior lipid profiles (LDL-C and non LDL-C levels).

Although there are several drugs approved to manage HIV virus infection, there is no cure available in the market. So far, Gilead Sciences (GILD - Free Report) and GlaxoSmithKline (GSK - Free Report) 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.

Zacks Rank & Stock to Consider

Merck currently has a Zacks Rank #3 (Hold).

Bristol-Myers Squibb Co. (BMY - Free Report) is a better-ranked stock from the same space, sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Bristol-Myers’ earnings per share estimates have increased from $3.42 to $3.59 for 2018 and from $3.65 to $3.83 for 2018 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 6.39%.

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