Merck & Co., Inc. MRK announced that the European Commission has approved two new HIV drugs — Pifeltro and Delstrigo — containing, doravirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI), for the treatment of HIV-1 infection.
While Pifeltro is a once-daily single tablet containing doravirine to be taken in combination with other antiretroviral agents, Delstrigo is a once-daily fixed-dose combination regimen containing doravirine, lamivudine and tenofovir disoproxil fumarate. In the EU, the drugs are indicated for the treatment of adults with HIV-1 infection without past or present evidence of resistance to the NNRTI class.
The approval was expected as in September, the Committee for Medicinal Products for Human Use of the European Medicines Agency had given a positive opinion recommending approval of the two medicines. Pifeltro and Delstrigo are expected to be launched in the EU in the first half of 2019.
So far this year, Merck’s shares have outperformed the industry. Merck’s shares have risen 37.2% in the period compared with 7.8% increase for the industry.
Pifeltro and Delstrigo were approved by the FDA in August, two months ahead of the action date in late October. In the United States, Pifeltro and Delstrigo are approved for use in adults with no prior antiretroviral treatment experience. Also, in the United States, Delstrigo was approved with boxed warning about post-treatment acute exacerbation of hepatitis B infection.
The approval to the drugs was based on encouraging data from two pivotal studies — DRIVE-AHEAD and DRIVE-FORWARD — evaluating the safety and efficacy of Delstrigo and Pifeltro, respectively through 90 weeks.
Although there are several drugs approved to manage HIV virus infection, there is no cure available in the market. So far, Gilead Sciences GILD and GlaxoSmithKline GSK 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 Eli Lilly & Company LLY, carrying a Zacks Rank #2. Lilly’s earnings estimates have increased 2% for 2018 and 1% for 2019 over the past 60 days. The company’s shares have increased 36.8% this year so far.
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