CHMP recommends approval of Pifeltro for HIV.- Merck Inc.

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Pifeltro (doravirine), from Merck Inc, intended for the treatment of HIV-1 infection. Pifeltro will be available as 100-mg film -coated tablets. The active substance of Pifeltro is doravirine, a new non-nucleoside reverse transcriptase inhibitor (NNRTI) which inhibits HIV -1 replication by non-competitive inhibition of HIV-1 reverse transcriptase. The benefits with Pifeltro are its ability to achieve a potent antiretroviral response in a once daily, single pill regimen. The most common side effects are nausea and headache. The full indication is: �Pifeltro is indicated, in combination with other antiretroviral medicinal products, for the treatment of adults infected with HIV-1 without past or present evidence of resistance to the NNRTI class (see sections 4.4 and 5.1).�

Recent US approval was based on data from the Phase III DRIVE-AHEAD and DRIVE-FORWARD studies. In the former, Delstrigo showed non-inferiority to Gilead Sciences' Atripla. In the latter, Pifeltro showed non-inferiority to Johnson & Johnson's Prezista plus 100 mg of ritonavir. Both treatments in DRIVE-FORWARD were administered in combination with either Gilead's Truvada or Epzicom/Kivexa. Comment: The oral medications are taken once-daily with or without food for adult HIV-1 patients who have never received antiretroviral treatment.