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November 29, 2018

Merck secures EC approval for Delstrigo and Pifeltro indications

The European Commission has granted approval to Merck for its indications Delstrigo and Pifeltro to treat adults with HIV-1. 

The European Commission has granted approval to Merck for its indications Delstrigo and Pifeltro to treat adults with HIV-1.

Delstrigo is a new once-daily, fixed-dose combination tablet of doravirine, lamivudine and tenofovir disoproxil fumarate. It has been indicated for use in the European Union.

Pifeltro is a new, once-daily NNRTI given in combination with other antiretroviral medicines.

Indicated for the treatment of HIV-1 infection in adults with no prior antiretroviral treatment experience in the US, both products are administered orally with or without food.

Merck Research Laboratories global clinical development, infectious diseases vice-president and therapeutic area head Dr George Hanna said: “We are very pleased that the European Commission has approved Delstrigo and Pifeltro, as this approval marks another important milestone in Merck’s unwavering commitment to the global HIV community.

“These medicines bring new treatment options with demonstrated efficacy that could potentially address unmet needs for people in Europe living with HIV.”

“These medicines bring new treatment options with demonstrated efficacy that could potentially address unmet needs for people in Europe living with HIV.”

Approvals are based on findings from the pivotal Phase III randomised, multi-centre, double-blind, active-controlled trials, DRIVE-AHEAD and DRIVE-FORWARD.

Following approval, the company will now be able to market Delstrigo and Pifeltro in all 28 European Union member states, in addition to Iceland, Lichtenstein, and Norway.

At present, marketing authorisation applications for the two indications are also under review in other countries, including Australia and Switzerland.

In August this year, the US Food and Drug Administration approved Delstrigo and Pifeltro. Health Canada approved Pifeltro last month, while Delstrigo secured approval earlier this month.

The two products are expected to be offered in the EU beginning first half of next year.

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