Merck's HIV Drug Isentress Gets FDA Approval For Higher Dose

Merck & Co., Inc. (NYSE:MRK) recently announced that the FDA has approved Isentress HD, a new 1,200 mg once daily dose of its marketed drug Isentress (raltegravir), in combination with other anti-retroviral therapies. The drug is meant for the treatment of adults and pediatric patients with HIV-1 infection (weighing at least 40 kg).

In such patients – adult or pediatric – the recommended dosage is 1,200 mg, comprising two 600 mg tablets once daily for the treatment of HIV-1 in treatment-naïve patients or patients whose virus remains suppressed after treatment with an initial regimen of 400 mg of Isentress twice-daily. Presently, Isentress is approved in a 400 mg twice daily formulation for the treatment of HIV-1 infection in adults.

We remind investors that the once-daily formulation of Isentress (600 mg tablets) received positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) earlier this month. A final decision on approval is expected in the second half of 2017.

Shares of Merck have outperformed the Zacks classified Large Cap Pharma industry in the last one year. The stock has gained 15.2% during the period, while the broader industry witnessed an increase of 1.8%.

Coming back to the latest news, the approval was supported by data from a phase III pivotal study (ONCEMRK) evaluating the efficacy and safety of Isentress in treatment-naive HIV-1 infected patients.

After 48 weeks of treatment, 89% of the patients in the Isentress HD arm (given as 2 x 600 mg once-daily) achieved viral suppression of HIV-1 RNA (

The company expects Isentress HD to be made available in pharmacies approximately in the next four weeks. We note that Isentress faces competitive pressure and is being impacted by slowing growth of the integrase class. Sales of the drug declined 10% in the first quarter of 2017 and 8% in 2016.

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Zacks Rank & Key Picks

Merck currently carries a Zacks Rank #2 (Buy). Stocks worth considering in the health care sector include VIVUS, Inc. (NASDAQ:VVUS) and Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) . VIVUS sports a Zacks Rank #1 (Strong Buy) while Regeneron carries a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank stocks here.

VIVUS’s loss per share estimates narrowed from 50 cents to 39 cents for 2017 over the last 30 days. The company posted positive earnings surprises in all the four trailing quarters with an average beat of 233.69%.

Regeneron’s earnings per share estimates increased from $10.17 to $10.52 for 2017 and from $10.90 to $12.10 for 2018 over the last 30 days. The company posted positive earnings surprises in two of the four trailing quarters with an average beat of 0.45%.

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